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The effect of ear acupressure on sexual functioning among lactating women: A randomized sham controlled trial
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Objective: Majority of breastfeeding women experience changes in sexual function. The present study was designed to assess effectiveness of auriculotherapy on improving sexual function in breastfeeding women.
Method: In this randomized sham controlled trial, accomplished from January 2018 to May 2019 in a referral sexual health clinic in city of Qom, Iran, 60 eligible participants were assigned to either intervention and control groups via block randomization. In the intervention group, electrical stimulation was applied for 15 seconds on Shen Men, Zero, Thalamic, Master Cerebral, Libido, Relax, Excitement, Ovary, and Uterus points in 10 auriculotherapy sessions. Then, Vaccaria seeds were stuck on these points. The control group received the same procedure with the device off as a sham method. Data were gathered using the Female Sexual Function Index (FSFI) at three different time points.
Results: At baseline, mean scores of sexual function dimensions were not significantly different between the intervention and control groups except for orgasm. Post-intervention, the results showed significant differences in sexual desire (P = 0.002), sexual arousal (P = 0.008), lubrication (P = 0.001), sexual satisfaction (P = 0.001), and orgasm (P = 0.009). One month after the intervention, the results showed significant differences in sexual desire, sexual arousal, lubrication, sexual satisfaction (P = 0.001), orgasm (P = 0.006), and dyspareunia (P = 0.015). Differences in mean score of sexual function in post-intervention and one-month follow-up were only significant in the intervention group (P = 0.001).
Conclusion: Based on evidence from this study, auriculotherapy is an effective technique for improving sexual function in breastfeeding women.
Many possible factors impact sexual wellbeing for women across the lifespan, and holistic approaches are being utilized to promote health and to address sexual concerns. Female sexual dysfunction disorders, including female orgasmic disorder, female sexual interest/arousal disorder and genito-pelvic pain/penetration disorder, negatively impact quality of life for many women. To reduce distress and improve sexual functioning, numerous behavioral therapies have been tested to date. Here, we present a state-of-the-art review of behavioral therapies for female sexual dysfunction disorders, focusing on empirically validated approaches. Multiple psychotherapies have varying degrees of support, with cognitive-behavioral and mindfulness-based therapies arguably having the most empirical support. Nonetheless, several limitations exist of the studies conducted to date, including the frequent grouping together of multiple types of sexual dysfunctions in randomized clinical trials. Thus, additional research is needed to advance treatment development for female sexual dysfunctions and to promote female sexual health.
Background
The impact of cancer diagnosis and treatment on sexual quality of life (SQoL) is a well-established survivorship issue for gynaecological cancer survivors (GCS), yet little is known on how to intervene.PurposeThe aim of this systematic review was to identify the factors explaining the variability in SQoL for GCS.Methods
We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework and the software Covidence. Electronic databases Scopus, Web of Science, PUBMED and CINAHL were searched for original research on GCS published between 2002 and 2018. We performed a two-stage screening process against selection criteria and quality assessment of individual studies. The Salutogenic Theory and the PRECEDE–PROCEED model were used as theoretical frameworks to identify and categorise factors.ResultsThe initial search yielded 3,505 articles resulting in a total of 46 studies used to examine the association between factors of SQoL and gynaecological cancers. Our findings suggested that SQoL varies across subgroups based on age, menopausal status, relationship status, and treatment modality. Protective factors included clinicians’ knowledge and confidence, preventive medical approach, risk and needs assessment, patient–clinician communication, relationship quality, psychosocial support, symptom management, accessibility of psychosexual care, and self-efficacy in the rediscovery of sexuality.Conclusion
Despite the high incidence and long-term impact of sexual health issues on quality of life, supportive care needs are not being met. A better understanding of the evidence base around the factors of SQoL can help health professionals take steps to protect and improve SQoL in GCS.
Background:
Lactation has a negative effect on female sexual function. Hormonal changes during lactation cause changes which might lead to dyspareunia, lack of libido, and anorgasmia. There are various pharmacological and non-pharmacological approaches to treat sexual dysfunction. While pharmacological treatment has multiple unwanted side effects, non-pharmacological therapies such as complementary medicine are a potential safer alternative. The aim of this study is to evaluate the effect of ear acupressure on sexual function of lactating women.
Methods/design:
This is a randomized clinical trial with a parallel sham control group. In this study, 76 lactating women between 6 months and 1 year after childbirth were referred to health care centers in Qazvin City and would be invited to participate. Participants will be divided into intervention (n = 38) and control (n = 38) groups using simple block randomization. Both intervention and sham control groups will be visited over 10 sessions within a 4-day interval. At each visit, the adhesives containing Vaccaria seed will be adhered for the intervention group, while non-latex-based adhesives with no Vaccaria seeds will be placed on the same ear acupoints for the sham control group. Selected ear acupoints include genitalia (two ear points), pelvic point, master shoulder, and posterior pituitary gland. The women will be asked to hold the seeds on their ears for 3 days and press each ear point three times a day for 20 s. After 3 days, they will be asked to remove the seeds from their ears and rest for 1 day. Sexual function as primary outcome in both groups will be assessed using the Female Sexual Function Index before and immediately after 1 and 2 months after the intervention. Also, Sexual Quality of Life as secondary outcome will be assessed using Sexual Quality of Life-Female (SQOL-F) before and 2 months after intervention. Data will be analyzed using repeated measure ANOVA at the significant level of 0.05.
Discussion:
This study is expected to support the impact of ear channel ear acupressure on sexual function in lactating women.
Trial registration:
Iranian Clinical Trial Registration Center IRCT20190626044028N1 . Registered on 16 August 2019.
BACKGROUND AND OBJECTIVES: Auriculotherapy is widely used to relieve painful conditions, therefore, allowing systematic reviews on the subject. However, they did not propose a unified bank of points of possible choice, their possible combinations or described the location of such points, thus making it the objective of this study. CONTENTS: The systematic review of revisions methodology (Overview) was chosen to achieve the proposed goal. The quality of such material was ascertained by the tool Assessment of Multiple Systematic Reviews, and the databases consulted were PEDro database, Pubmed, Scielo, and LILACS. The keywords and boolean index applied were: auriculotherapy AND pain; ear acupuncture AND pain, ear acupressure AND pain; auricular therapy and pain; auricular medicine AND pain. A total of 242 studies were found, but only six were systematic reviews in humans involving pain and auriculotherapy alone (without association with another technique). The methodological quality of the studies was high (8-10/11 Assessment of Multiple Systematic Reviews). There is variability in the neurophysiological explanation of action, many possible disorders that can be approached with auriculotherapy (acute, chronic, trauma, pre- and postoperative pain among others). Auriculotherapy showed to be promising in the remission of the pain, adjunct to the conventional treatment, low risk, cost, and easy administration. CONCLUSION: There are several ways of justifying its neurophysiological effects, and the most used points were ShenMen, the corresponding somatotopic region and the cavum conchae region (vagal stimulation). Auriculotherapy meets the needs of an immense possibility of painful musculoskeletal conditions, with favorable and promising results. Keywords: Auriculotherapy, Modalities of physiotherapy, Pain, Physiotherapy, Rehabilitation, Traditional Chinese Medicine.
The transition to parenthood following childbirth can be socially and emotionally significant, impacting on postnatal sexual functioning. This study aimed to conduct a systematic review of the literature on mothers’ experiences of sex and sexual intimacy in the first postnatal year, since an early meta-analysis was conducted in 1996. Systematic review strategies of nine databases were conducted to identify relevant literature. Electronic databases were searched for English language, peer-reviewed literature using search terms relating to ‘sex’, ‘intimacy’, ‘postnatal’, ‘experience’, and ‘twelve months’ and their quality was systematically assessed. Thirteen studies meeting the criteria were included. Women typically resumed sexual intercourse during the early postnatal weeks when the prevalence of sexual health problems was high. Women experienced significantly more sexual problems, such as pain and dyspareunia following perineal trauma, yet sexual functioning changes or problems were rarely explored by healthcare professionals. Consistent with earlier reviews, this review demonstrated the lack of focus on all aspects of sexual intimacy post-natally. The prevalence of postnatal sexual problems following perineal trauma highlights the need for interventions aimed at supporting these women, including healthcare professionals providing information, and having discussions with women regarding postnatal sexual changes and possible problems.
Traditional Chinese Medicine (TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM Extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestion for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.
Sexual changes after childbirth between couples are an important factor in creating a sense of satisfaction which
effects on their quality of life. Aim: to evaluate effect of PLISSIT Model sexual counseling program on sexual quality of life
for postpartum women. Research design: A quasi experimental design. Setting: The study was conducted in Obstetrics and
Gynecological Outpatient Clinic at Benha University Hospital. Sample: A purposive sample of all admitted postpartum women
for a period of 6 months (110) woman. Tools: Three tools were used I): An interviewing questionnaire. II): Arizona Sexual
Experience Scale. III) The sexual quality of life-female questionnaire. Results: showed that the mean age of studied women
were 25.02 ± 4.47 years, 85.5% of women did not receive information about sexuality, 72.3% suffered from pain during
intercourse after labor, 63.6% of them returned to sexual relation six week after labor. Only 13.6% of women had good total
sexual quality of life before PLISSIT model counseling program, which increased to 44.5% after program. there were highly
statistically significant differences between women regarding Arizona Sexual Experiences Scale and all sexual quality of life
items before and after sexual counseling program (p<0.001). Conclusion: the PLISSIT model counseling program had a
significant effect on the improvement of the women' sexual quality of life. Recommendations: Establish strategies to facilitate
the women’s understanding and support sexual quality of life through apply this study on a large sample at outpatient clinics.
Keywords: PLISSIT Model Counseling Program, Postpartum Women, Quality of Sexual Life
Background:
the transition to parenthood (TTP) is associated with changes to a couple's relationship. Quantitative evidence shows the TTP is associated with reduced satisfaction and quality of a couples' relationships. Qualitative research provides information on the lived experience of couples in the TTP so can provide a more in-depth understanding of the impact. This review therefore aimed to synthesise qualitative research of the perceived impact of the TTP on a couple's relationship in contemporary Western society.
Design:
a systematic search was conducted of nine databases and grey literature. Key author, citation and reference searches were also undertaken. Papers were included if they presented qualitative data of romantic partner relationships during the TTP with parents aged 18 or over. Studies were restricted to those conducted from 1996 in Western societies. Analysis was conducted using meta-ethnography.
Findings:
searches identified 5256 papers. After applying inclusion criteria 12 papers were included in the meta-synthesis. Six main themes were identified: (1) Adjustment Phase (a period of change in the relationship), (2) Focus on the Baby (with a sub-theme of feeling unprepared for the relationship impact), (3) Communication (shifts in communication patterns and importance), (4) Intimacy (changes to sexual relations, romance and closeness), (5) Strain on the Relationship (short-term or prolonged), and (6) Strengthened Relationships (deepening of connection and new affinity). Except for the themes of Strain on the Relationship and Strengthened Relationships, the findings showed the TTP had positive and negative impacts on couples' relationships.
Key conclusions and implications for practice:
the review highlights a range of TTP relationship issues that couples experience and may require help with. Health care professionals working with parents in the TTP may be able to provide support through antenatal education that includes preparation for relationship changes, and provision of postnatal support to identify and overcome problems.
Background
Missing data may seriously compromise inferences from randomised clinical trials, especially if missing data are not handled appropriately. The potential bias due to missing data depends on the mechanism causing the data to be missing, and the analytical methods applied to amend the missingness. Therefore, the analysis of trial data with missing values requires careful planning and attention.
Methods
The authors had several meetings and discussions considering optimal ways of handling missing data to minimise the bias potential. We also searched PubMed (key words: missing data; randomi*; statistical analysis) and reference lists of known studies for papers (theoretical papers; empirical studies; simulation studies; etc.) on how to deal with missing data when analysing randomised clinical trials.
Results
Handling missing data is an important, yet difficult and complex task when analysing results of randomised clinical trials. We consider how to optimise the handling of missing data during the planning stage of a randomised clinical trial and recommend analytical approaches which may prevent bias caused by unavoidable missing data. We consider the strengths and limitations of using of best-worst and worst-best sensitivity analyses, multiple imputation, and full information maximum likelihood. We also present practical flowcharts on how to deal with missing data and an overview of the steps that always need to be considered during the analysis stage of a trial.
Conclusions
We present a practical guide and flowcharts describing when and how multiple imputation should be used to handle missing data in randomised clinical.
Electronic supplementary material
The online version of this article (10.1186/s12874-017-0442-1) contains supplementary material, which is available to authorized users.
This study explored the level of production and contents
of information available within the global context on
the approach of sexuality in individuals with chronic
disease (CD). The following main themes were
identified: sexuality as a human right and fundamental
part of health for individuals with CD, factors present in
situations of CD that generate alterations in sexuality,
and the models for assessment, measurement, and
intervention of the phenomenon. Scientific production is
scarce and limited on sexuality during CD, with the most
part of said production from recent years.
The outcome of acupuncture on hypertension treatment is inconclusive. This study aims to evaluate the influence of acupuncture on hypertension, based on findings from mechanistic studies over the course of decades particularly those conducted at the University of California, Irvine. Low-current and low-frequency electroacupuncture (EA) at P5–6 (overlying the median nerve) and S36–37 (overlying the deep peroneal nerve) reduced high blood pressure in a subset of patients (~70 %) with mild-to-moderate hypertension, in a slow-onset (4–8 weeks) but long-lasting (1–2 months) manner. EA inhibited cardiovascular sympathoexcitatory neurons through activation of neurons in the arcuate nucleus of the hypothalamus, the ventrolateral periaqueductal gray in the midbrain and the nucleus raphe pallidus in the medulla, through inhibiting the activity of premotor sympathetic neurons in the rostral ventrolateral medulla (rVLM). Several neurotransmitters such as glutamate, acetylcholine, opioids, GABA, nociceptin, serotonin and endocannabinoids were involved in this EA-induced hypotensive response. The long-lasting inhibition of hypertension induced by EA was related to opioids and GABA in the rVLM, neural circuitry between the arcuate and ventrolateral periaqueductal gray, and prolongation of the increase in preproenkephalin mRNA levels and enkephalin levels in the rVLM and arcuate. Moreover, the long-lasting inhibition of sympathetic activity by EA was confirmed in EA-treated hypertensive patients with decreased levels of norepinephrine, renin and aldosterone.
Introduction:
Female sexual dysfunction affects up to 43% of women in the United States and hypoactive sexual desire disorder (HSDD) is the most common type; however, we lack treatment options showing improvement for this condition.
Aims:
To investigate whether acupuncture therapy could improve HSDD.
Methods:
Premenopausal women with a primary diagnosis of HSDD were included in a single-arm prospective pilot study that was approved by the institutional review board. After providing informed consent, subjects completed validated questionnaires. Participants underwent 25-minute twice-weekly acupuncture sessions for 5 weeks with one certified acupuncturist. Questionnaires were completed again 6 weeks after onset of treatment.
Main outcome measures:
Based on a statistically significant change in the desire domain of the Female Sexual Function Index from 2.0 (at baseline) to 2.4 (after intervention with a specialist) in our population of patients diagnosed with HSDD, a sample of 13 was determined, with 90% power and α 0.05.
Results:
Fifteen women were enrolled and 13 completed the study. Mean age was 36.9 ± 11.4 years. Most were white (n = 9, 60%), heterosexual (n = 15, 100%), and non-smokers (n = 14, 93%). Most were sexually active more than four times per month (n = 8, 53%) and none had a history of sexual abuse (n = 15, 100%). Participants received a mean acupuncture needle application of 17 ± 2 at each session. Sexual function improved after intervention, particularly desire (2.1 ± 0.6 to 3.3 ± 1.2, P < .0001), arousal (P < .0001), lubrication (P = .03), and orgasm (P = .005).
Conclusion:
In this cohort of premenopausal women with HSDD, 5 weeks of acupuncture therapy was associated with significant improvements in sexual function, particularly desire. This supports a role for acupuncture as a therapeutic option for women with low desire.
Auricular therapy (AT) has been historically viewed as a convenient approach adjunct to pharmacological therapy for cancer patients with chemotherapy-induced nausea and vomiting (CINV). The aim of this study was to assess the evidence of the therapeutic effect of AT for CINV management in cancer patients. Relevant randomized controlled trials were retrieved from 12 electronic databases without language restrictions. Meanwhile, manual search was conducted for Chinese journals on complementary medicine published within the last five years, and the reference lists of included studies were also checked to identify any possible eligible studies. Twenty-one studies with 1713 participants were included. The effect rate of AT for managing acute CINV ranged from 44.44% to 93.33% in the intervention groups and 15% to 91.67% in the control groups. For delayed CINV, it was 62.96% to 100% and 25% to 100%, respectively. AT seems to be a promising approach in managing CINV. However, the level of evidence was low and the definite effect cannot be concluded as there were significant methodological flaws identified in the analyzed studies. The implications drawn from the 21 studies put some clues for future practice in this area including the need to conduct more rigorously designed randomized controlled trials.
Introduction:
There is growing recognition of female sexual dysfunction (FSD) as an important women's health concern. Despite an increased awareness of the pathophysiologic components to FSD, currently, there are no drugs approved for the most common sexual complaint in women-decreased sexual desire. In response to an overwhelming demand for therapy for FSD, several drugs are undergoing development and testing.
Areas covered:
The aim of this paper is to provide the latest data on pharmacological treatments for FSD currently in Phase I and II clinical trials. These include topical alprostadil, bremelanotide (BMT), intranasal testosterone (TBS-2), intravaginal dehydroepiandrosterone (DHEA), sublingual testosterone with sildenafil, apomorphine (APO), bupropprion and trazodone. It should be noted that the definitions of FSD have recently been revised in the diagnostic and statistical manual for mental disorders (DSM) 5, with merging of hypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD) into female sexual interest/arousal disorder (FSIAD). However, it is noted that the majority of clinical trials discussed in this paper use the DSM IV-R diagnoses of HSDD and FSAD.
Expert opinion:
Medications in early phase trials show promise for the treatment of FSD. These therapies focus on treating many possible causes of FSD. Concerns over gender bias within the FDA need to be resolved given the need for new treatment options for FSD.
This study explored the level of production and contents of information available within the global context on the approach of sexuality in individuals with chronic disease (CD). The following main themes were identified: sexuality as a human right and fundamental part of health for individuals with CD, factors present in situations of CD that generate alterations in sexuality, and the models for assessment, measurement, and intervention of the phenomenon. Scientific production is scarce and limited on sexuality during CD, with the most part of said production from recent years.
Abstract Ear-acupuncture/ear-acupressure (EAP) has been used for a range of health conditions with numerous randomized controlled trials (RCTs) investigating its efficacy and safety. However, the design of sham interventions in these RCTs varied significantly. This study systematically reviewed RCTs on EAP for all clinical conditions involving a number of sham EAPs as a control intervention. The review is guided by the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 and investigated the types and differences of sham EAP interventions. Four electronic English databases (The Cochrane Library, PubMed, Embase, CINAHL(®)) and two Chinese databases (CQVIP, CNKI) were searched in December 2012 and 55 published RCTs comparing real and sham EAP for any clinical condition were included. Characteristics of participants, real and sham interventions, and outcomes were extracted. Four types of sham methods were identified. Among the 55 RCTs, 25 studies involved treatment on nonspecific ear acupoints as the sham method; seven studies used nonacupoints on the ear; nine studies selected placebo needles or placebo ear-acupressure on the same ear acupoints for the real treatment; 10 studies employed pseudo-intervention; and five studies combined two of the above methods to be the sham control. Other factors of treatment such as number of points, treatment duration, and frequency also varied greatly. Risk of bias assessment suggests that 32 RCTs were "high risk" in terms of participants blinding, and 45 RCTs were "high risk" in terms of personnel blinding. Meta-analysis was not conducted due to the high clinical heterogeneity across included studies. No relationship was found between the sham designs and efficacy outcomes, or between the sham types and dropout rate. No solid conclusion of which design is the most appropriate sham control of EAP could be drawn in this review.
Randomized clinical trials are the gold standard for evaluating interventions as randomized assignment equalizes known and unknown characteristics between intervention groups. However, when participants miss visits, the ability to conduct an intent-to-treat analysis and draw conclusions about a causal link is compromised. As guidance to those performing clinical trials, this review is a non-technical overview of the consequences of missing data and a prescription for its treatment beyond the typical analytic approaches to the entire research process. Examples of bias from incorrect analysis with missing data and discussion of the advantages/disadvantages of analytic methods are given. As no single analysis is definitive when missing data occurs, strategies for its prevention throughout the course of a trial are presented. We aim to convey an appreciation for how missing data influences results and an understanding of the need for careful consideration of missing data during the design, planning, conduct, and analytic stages.
Background:
Antidepressants including selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs) are known to cause secondary sexual dysfunction with prevalence rates as high as 50%-90%. Emerging research is establishing that acupuncture may be an effective treatment modality for sexual dysfunction including impotence, loss of libido, and an inability to orgasm.
Objectives:
The purpose of this study was to examine the potential benefits of acupuncture in the management of sexual dysfunction secondary to SSRIs and SNRIs.
Subjects:
Practitioners at the START Clinic referred participants experiencing adverse sexual events from their antidepressant medication for acupuncture treatment at the Mood and Anxiety Disorders, a tertiary care mood and anxiety disorder clinic in Toronto.
Design:
Participants received a Traditional Chinese Medicine assessment and followed an acupuncture protocol for 12 consecutive weeks. The acupuncture points used were Kidney 3, Governing Vessel 4, Urinary Bladder 23, with Heart 7 and Pericardium 6. Participants also completed a questionnaire package on a weekly basis.
Outcomes measured:
The questionnaire package consisted of self-report measures assessing symptoms of depression, anxiety, and various aspects of sexual function.
Results:
Significant improvement among male participants was noted in all areas of sexual functioning, as well as in both anxiety and depressive symptoms. Female participants reported a significant improvement in libido and lubrication and a nonsignificant trend toward improvement in several other areas of function.
Conclusions:
This study suggests a potential role for acupuncture in the treatment of the sexual side-effects of SSRIs and SNRIs as well for a potential benefit of integrating medical and complementary and alternative practitioners.
Auricular acupuncture has been described in ancient China as well as Egypt, Greece, and Rome. At the end of the 1950s, ear acupuncture was further developed by the French physician Dr. Paul Nogier. The goal of this study was to develop a new system for ear acupressure (vibration stimulation) and to perform pilot investigations on the possible acute effects of vibration and manual ear acupressure on heart rate (HR), heart rate variability (HRV), pulse wave velocity (PWV), and the augmentation index (AIx) using new noninvasive recording methods. Investigations were performed in 14 healthy volunteers (mean age ± SD: 26.3 ± 4.3 years; 9 females, 5 males) before, during, and after acupressure vibration and manual acupressure stimulation at the "heart" auricular acupuncture point. The results showed a significant decrease in HR (P ≤ 0.001) and a significant increase in HRV total (P = 0.008) after manual ear acupressure. The PWV decreased markedly (yet insignificantly) whereas the AIx increased immediately after both methods of stimulation. The increase in the low-frequency band of HRV was mainly based on the intensification of the related mechanism of blood pressure regulation (10-s-rhythm). Further studies in Beijing using animal models and investigations in Graz using human subjects are already in progress.
The Publication Manual of the American Psychological Association (American Psychological Association, 2001, American Psychological Association, 2010) calls for the reporting of effect sizes and their confidence intervals. Estimates of effect size are useful for determining the practical or theoretical importance of an effect, the relative contributions of factors, and the power of an analysis. We surveyed articles published in 2009 and 2010 in the Journal of Experimental Psychology: General, noting the statistical analyses reported and the associated reporting of effect size estimates. Effect sizes were reported for fewer than half of the analyses; no article reported a confidence interval for an effect size. The most often reported analysis was analysis of variance, and almost half of these reports were not accompanied by effect sizes. Partial η2 was the most commonly reported effect size estimate for analysis of variance. For t tests, 2/3 of the articles did not report an associated effect size estimate; Cohen's d was the most often reported. We provide a straightforward guide to understanding, selecting, calculating, and interpreting effect sizes for many types of data and to methods for calculating effect size confidence intervals and power analysis.
Randomized controlled trials (RCTs) that use the modified intention-to-treat (mITT) approach are increasingly being published. Such trials have a preponderance of post-randomization exclusions, industry sponsorship, and favourable findings, and little is known whether in terms of these items mITT trials are different with respect to trials that report a standard intention-to-treat.
To determine differences in the methodological quality, sponsorship, authors' conflicts of interest, and findings among trials with different "types" of intention-to-treat, we undertook a cross-sectional study of RCTs published in 2006 in three general medical journals (the Journal of the American Medical Association, the New England Journal of Medicine and the Lancet) and three specialty journals (Antimicrobial Agents and Chemotherapy, the American Heart Journal and the Journal of Clinical Oncology). Trials were categorized based on the "type" of intention-to-treat reporting as follows: ITT, trials reporting the use of standard ITT approach; mITT, trials reporting the use of a "modified intention-to-treat" approach; and "no ITT", trials not reporting the use of any intention-to-treat approach. Two pairs of reviewers independently extracted the data in duplicate. The strength of the associations between the "type" of intention-to-treat reporting and the quality of reporting (sample size calculation, flow-chart, lost to follow-up), the methodological quality of the trials (sequence generation, allocation concealment, and blinding), the funding source, and the findings was determined. Odds ratios (OR) were calculated with 95% confidence intervals (CI).
Of the 367 RCTs included, 197 were classified as ITT, 56 as mITT, and 114 as "no ITT" trials. The quality of reporting and the methodological quality of the mITT trials were similar to those of the ITT trials; however, the mITT trials were more likely to report post-randomization exclusions (adjusted OR 3.43 [95%CI, 1.70 to 6.95]; P < 0.001). We found a strong association between trials classified as mITT and for-profit agency sponsorship (adjusted OR 7.41 [95%CI, 3.14 to 17.48]; P < .001) as well as the presence of authors' conflicts of interest (adjusted OR 5.14 [95%CI, 2.12 to 12.48]; P < .001). There was no association between mITT reporting and favourable results; in general, however, trials with for-profit agency sponsorship were significantly associated with favourable results (adjusted OR 2.30; [95%CI, 1.28 to 4.16]; P = 0.006).
We found that the mITT trials were significantly more likely to perform post-randomization exclusions and were strongly associated with industry funding and authors' conflicts of interest.
In 1984, Jacobson, Follette, and Revenstorf defined clinically significant change as the extent to which therapy moves someone outside the range of the dysfunctional population or within the range of the functional population. In the present article, ways of operationalizing this definition are described, and examples are used to show how clients can be categorized on the basis of this definition. A reliable change index (RC) is also proposed to determine whether the magnitude of change for a given client is statistically reliable. The inclusion of the RC leads to a twofold criterion for clinically significant change.
Introduction: Sexual activity and satisfaction from it is known as one of the most important aspects of human life that is affected by multiple factors such as pregnancy and childbirth. Given the fact that awareness of sexual problems in the postpartum period can be effective in improving quality of care in this period, this study was performed to determine sexual problems of breastfeeding women in Bandar Abbas.
Methods: This descriptive, cross-sectional study was carried out on 130 primipara breastfeeding women referred to Seyed-Alshohada health center of Bandar Abbas, Iran, in 2015. Data collection tools were a form of demographic and obstetric information and Brief Sexual Symptom Checklist (BSSC). To analyze the data, descriptive (frequency and mean) and analytical (logistic) statistics were used in SPSS, version 16. P-value less than 0.05 was considered statistically significant.
Results: The mean number of sexual intercourse during the postpartum period was 1.33±1.09 in a week and the mean time to resumption of the first intercourse was 6.81±2.12 postpartum weeks. Most sexual problems reported by women during the postpartum period were dyspareunia 111 (85.4%), orgasm problem 110 (84.6%), lack of sexual lubrication 107(82.3%), lack of sexual desire 104 (80%), and sexual arousal problem 96 (73.8%). All the sexual problems were more prevalent in the first two months after delivery, which diminished four and six months after delivery (P<0.001).
Conclusion: In general, sexual problems are more frequent in the first two postpartum months, which reduces four and six months after delivery. Because of high prevalence of sexual problems in this period, training programs for empowering midwives to deal with sexual problems of their clients can be an important step towards activating midwives regarding their role in this important portion of their duties.
Aim:
To investigate the effect of auricular acupressure on the severity of postpartum blues.
Methods:
A randomized sham controlled trial was conducted from February to November 2021, with 74 participants who were randomly allocated into two groups of either routine care + auricular acupressure (n = 37), or routine care + sham control (n = 37). Vacaria seeds with special non-latex adhesives were used to perform auricular acupressure on seven ear acupoints. There were two intervention sessions with an interval of five days. In the sham group, special non-latex adhesives without vacaria seeds were attached in the same acupoints as the intervention group. Severity of postpartum blues, fatigue, maternal-infant attachment, and postpartum depression were assessed.
Results:
Auricular acupressure was associated with significant effect in reduction of postpartum blues on 10th and 15th days after childbirth (SMD = -2.77 and -2.15 respectively), postpartum depression on the 21st day after childbirth (SMD = -0.74), and maternal fatigue on 10th, 15th and 21st days after childbirth (SMD = -2.07, -1.30 and -1.32, respectively). Also, maternal-infant attachment was increased significantly on the 21st day after childbirth (SMD = 1.95).
Conclusion:
Auricular acupressure was effective in reducing postpartum blues and depression, reducing maternal fatigue, and increasing maternal-infant attachment in the short-term after childbirth.
Trial registration:
Registered prospectively in Iranian Registry of Clinical Trials (ID: IRCT20180218038789N2).
Introduction
: Pain control after a cesarean section remains a challenge for healthcare professionals and both pharmacological and non-pharmacological treatment methods can be used to reduce this pain. The present study evaluated the effect of auricular acupressure (applied using the finger) combined with routine care on the short-term pain severity compared to sham acupressure or routine care alone.
Methods
: A randomized controlled clinical trial with three parallel groups was conducted between April and May 2021. Participants were pregnant women aged 18-35 years, of gestational age 37-40 weeks who underwent cesarean section according to the anesthesia protocol provided in Imam Ali Hospital, Amol, Mazandaran, Iran. Using the balanced blocks randomization method, participants were randomly allocated into three study groups. Participants (N=180) were randomly assigned to either routine care with auricular acupressure (n=60), routine care with sham control (n=61), or routine care only (n=59). The intervention (auricular acupressure) was performed by a trained nurse three times (three, five, and seven hours after surgery) on ear acupoints including Shen Men, Point Zero, Pelvic, abdomen, Endocrine, and Uterus points, in both ears. The primary outcome was pain severity assessed using the Visual Analog Scale (VAS) at eight time points (i.e., before the intervention, and then 15, 30, and 60 minutes after the intervention, and 3, 6, 12, and 24 hours after the intervention). Patients and outcome assessors were blind.
Results
: The pain intensity in the three groups was not significantly different until 6 hours after the intervention. The level of pain in the intervention group receiving auricular acupressure was significantly lower than the sham group at 6 hours (MD: -1.06 [95% CI: -1.83; -0.30]), 12 hours (MD: -1.24 [95% CI: -1.96; -0.52]), and 24 hours (MD: -1.21 [95% CI: -1.96; -0.47]) after the intervention. Also, the pain intensity in the intervention group was significantly lower than the control group at 6 hours (MD: -0.80 [95% CI: -1.53; -0.08]), 12 hours (MD: -0.98 [95% CI: -1.67; -0.30]) and 24 hours (MD: -1.00 [95% CI: -1.70; -0.29]) after the intervention. Moreover, no adverse outcomes were observed related to auricular acupressure.
Conclusion
: Auricular acupressure might be an effective adjuvant complementary treatment for post-operative cesarean pain in controlling pain and reducing the need for analgesics with no adverse effect.
Trial registration
: Registered prospectively in the Iranian Registry of Clinical Trials (Decree code: IRCT20130822014436N1).
Funding
: Mazandaran University of Medical Sciences.
Objectives
Sexual dysfunction can adversely affect the quality of life and interpersonal relationships. nowadays, a lot of attention is paid to traditional Chinese medicine with better curative effects and less adverse events. Recent studies have implied the promising effect of acupuncture on sexual function. This systematic review evaluate the effectiveness and safety of acupuncture in treating female and male sexual dysfunction.
Content
PubMed, Cochrane Central of Controlled Trials (CENTRAL), EMBASE, Web of Science, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), Scopus, and Google Scholar were searched up to 2021. No limitation to language and date. The methodological quality of the studies was assessed using the Mixed Methods Appraisal Tool (MMAT).
Summary
Among 160 initially assessed papers, 13 articles were included. The findings showed that acupuncture improve sexual dysfunction in domains of desire, libido, erectile dysfunction and impotency. Most studies did not report any serious side effects from acupuncture, and only three studies reported minor adverse events.
Outlook
The available evidence indicate that acupuncture has positive on improvement of sexual dysfunction with no serious side effects. Although acupuncture has gained increasing popularity for the management of sexual dysfunction, high methodological quality evidence regarding its efficacy is lacking.
Prolactin is a proteic hormone best known for its role in enabling the production of milk by female mammals. Secreted by the pituitary gland in response to the stimuli of eating, estrogen treatment, mating, ovulation and nursing, prolactin is involved in over 300 separate processes in a range of vertebrates, including humans. The hormone is released in a pulsatile manner and plays an essential role in metabolism, as well as in the regulation of the immune system and pancreatic development. Nevertheless, prolactin exerts other relevant roles, as it acts at the central nervous system level to modulate behavior, arousal and sexuality. In this experts’ opinion, we aim to give insights into the main activities of prolactin to advance the ability of medical doctors and specialists in obstetrics and gynecology to provide more emphasis in their clinical practices to the link between prolactin and sexuality.
Objectives
This study sought to compare the effects of multi-point ear and body acupressure on labor pain and the duration of labor active phase.
Design
Three-armed randomized controlled trial
Setting
Kowsar Hospital, Qazvin, Iran
Intervention
Participants in the body acupressure group received acupressure on GB21, GB30, BL32, LI4, and SP6 points, each for two minutes, at cervical dilation of four, six, and eight centimeters. For participants in the ear acupressure group, adhesive auriculotherapy-specific Vaccaria seeds were attached to their auricles on the zero, genitalia, Shen Men, thalamic, and uterine 1 and 2 acupoints. The seeds were compressed every thirty minutes, each time for thirty seconds. Participants in the control group received routine care services.
Main outcome measures
Labor pain intensity was assessed using a visual analogue scale at cervical dilation of four and ten centimeters.
Results
While there was no significant difference between mean scores of pain among three groups, mean score of labor pain in both acupressure groups was significantly less than that in the control group (P < 0.001). However, the difference between the acupressure groups was not statistically significant (P = 0.12). Moreover, the duration of labor active phase in the ear acupressure group was significantly less than those in the body acupressure and the control groups (P < 0.001).
Conclusion
Ear acupressure was significantly effective in reducing labor pain and shortening labor active phase. However, body acupressure solely reduces labor pain. Therefore, ear acupressure can be used to reduce labor pain and shorten labor active phase.
Objective:
The minimal clinically important difference (MCID) of a patient-reported outcome measure (PROM) represents a threshold value of change in PROM score deemed to have an implication in clinical management. The MCID is frequently used to interpret the significance of results from clinical studies that use PROMs. However, an understanding of the many caveats of the MCID, as well as its strengths and limitations, is necessary. The objective of this article is to provide a review of the calculation, interpretation, and caveats of MCID.
Data sources:
MEDLINE and PubMed Central.
Review methods:
Literature search-including primary studies, review articles, and consensus statements-pertinent to the objectives of this review using PubMed.
Conclusions:
The MCID of a PROM may vary depending on the patients and clinical context in which the PROM is given. The primary approaches for calculating MCID are distribution-based and anchor-based methods. Each methodology has strengths and limitations, and the ideal determination of a PROM MCID includes synthesis of results from both approaches. The MCID of a PROM is also not perfect in detecting patients experiencing a clinically important improvement, and this is reflected in its accuracy (eg, sensitivity and specificity).
Implications for practice:
Interpretation or application of MCID requires consideration of all caveats underlying the MCID, including the patients in whom it was derived, the limitations of the methodologies used to calculate it, and its accuracy for identifying patients who have experienced clinically significant improvement.
Introduction: Female sexual dysfunction (FSD) is a highly prevalent, yet commonly underdiagnosed and undertreated condition. This paper reviews the diagnostic terminology for FSD, and basic sexual physiology in women. The Food and Drug Administration (FDA) approved drugs for FSD are discussed, followed by investigational drugs for FSD currently in phase 2 or 3 clinical trials, reasons for failure of drug development, and potential future drug targets.
Areas Covered: A literature review was conducted for available treatments for FSD: flibanserin, estrogen, ospemifene and prasterone. Potential treatments are assessed, as was the Pharmaprojects database which includes clinical trial information. Testosterone, bremelanotide, bupropion-trazodone, PDE-5 inhibitors, prostaglandins, tibolone and combination therapies, and the theoretical basis of potential drug targets are discussed.
Expert opinion: The lack of established endpoints for phase 3 studies of FSD has impeded approval of new treatments, and required additional studies for validation, resulting in proposed changes to the FDA draft guidance for FSD clinical trials in October 2016. Current DSM-5 diagnostic nosology also fails to capture the full range of symptomology. Several promising compounds have shown no movement for several years limiting women’s options. Overcoming socio-cultural bias against women’s sexual and reproductive health will be critical in the approval of new treatments for FSD.
Introduction:
There are major problems with failure to replicate research findings. Contributing to this problem is a failure to report on factors related to external validity. Frequently, researchers have little knowledge whether findings apply more generally, especially to low-resource settings and underserved populations. The CONSORT flow diagram has improved reporting on variables related to internal validity, but it has very limited detail on issues related to external validity. A recent CONSORT update and other publications have called for more transparent reporting on external validity and context, and information regarding the sustainability of interventions. All of these elements influence the generalizability of findings from outcomes research.
Methods:
Drawing on theory, a prior meeting, and recent recommendations for reporting factors related to external validity, the authors propose an expansion of the basic CONSORT flow diagram for clinical trials to concisely summarize these data that recent CONSORT statements and other guidelines have recommended.
Results:
The authors propose the use of an expanded CONSORT figure and illustrate its utility with an example. The expanded CONSORT figure adds data about participation and representativeness at the levels of settings and staff, and about intervention sustainability after project support ends. The authors provide an expanded CONSORT figure reporting template, and demonstrate its use.
Conclusions:
Improving transparent reporting on external validity by using the proposed expanded CONSORT figure would help to address both the scientific replication crisis and health equity concerns. This figure provides a method to efficiently address the representativeness, generalizability, and sustainability of outcomes research.
Background and purpose: Quality of life (QOL) is believed to be influenced by sexual function during menopause. The aim of this study was to investigate the relationship between sexual function and QOL among post-menopausal women. Materials and methods: We performed a community-based, descriptive-analytical study of 405 post-menopausal women, aged 40 to 65 years. A multi-stage, randomized sampling was conducted. Data was obtained through interviews using the Female Sexual Function Index (FSFI), World Health Organization Quality of Life-BRIEF)WHOQOL-BREF(, and a researcher-made questionnaire. Data was then analyzed using t-test and multiple linear regression. Results: The mean age and mean duration of menopause were 52.84±3.7 years and 19.8±14.4 months, respectively. Among the subjects 324 (80%) were housewives and 369 (91.2%) had diploma or lower levels of education. The mean total score of QOL was 54.53±7.18. The highest and lowest scores were associated with physical health and psychological health domains, respectively. Overall, 61% had female sexual dysfunction (FSD). The total scores for FSFI were in a positive correlation with the total scores for WHOQOL-BREF (r=0.285, P<0.001) and the scores for all domains of QOL. The scores in all domains of FSFI, except in the domain of pain, had a positive correlation with the total score of QOL (P<0.001). Satisfaction with marital relationship in post-menopausal women was associated with an increase in QOL (P<0.001, r=0.258). Conclusion: Sexual dysfunction could have a negative impact on the quality of life in post-menopausal women. Therefore, to enhance the quality of life in this population sexual dysfunction requires more attention when implementing women’s health initiatives. © 2016, Mazandaran University of Medical Sciences. All Rights reserved.
Introduction: Female sexual dysfunction affects up to 43% of women in the United States and hypoactive sexual desire disorder (HSDD) is the most common type; however, we lack treatment options showing improvement for this condition.
Aims: To investigate whether acupuncture therapy could improve HSDD.
Methods: Premenopausal women with a primary diagnosis of HSDD were included in a single-arm prospective pilot study that was approved by the institutional review board. After providing informed consent, subjects completed validated questionnaires. Participants underwent 25-minute twice-weekly acupuncture sessions for 5 weeks with one certified acupuncturist. Questionnaires were completed again 6 weeks after onset of treatment.
Main Outcome Measures: Based on a statistically significant change in the desire domain of the Female Sexual Function Index from 2.0 (at baseline) to 2.4 (after intervention with a specialist) in our population of patients diagnosed with HSDD, a sample of 13 was determined, with 90% power and α 0.05.
Results: Fifteen women were enrolled and 13 completed the study. Mean age was 36.9 ± 11.4 years. Most were white (n = 9, 60%), heterosexual (n = 15, 100%), and non-smokers (n = 14, 93%). Most were sexually active more than four times per month (n = 8, 53%) and none had a history of sexual abuse (n = 15, 100%). Participants received a mean acupuncture needle application of 17 ± 2 at each session. Sexual function improved after intervention, particularly desire (2.1 ± 0.6 to 3.3 ± 1.2, P < .0001), arousal (P < .0001), lubrication (P = .03), and orgasm (P = .005).
Conclusion: In this cohort of premenopausal women with HSDD, 5 weeks of acupuncture therapy was associated with significant improvements in sexual function, particularly desire. This supports a role for acupuncture as a therapeutic option for women with low desire.
Most questions in social and biomedical sciences are causal in nature: what would happen to individuals, or to groups, if part of their environment were changed? In this groundbreaking text, two world-renowned experts present statistical methods for studying such questions. This book starts with the notion of potential outcomes, each corresponding to the outcome that would be realized if a subject were exposed to a particular treatment or regime. In this approach, causal effects are comparisons of such potential outcomes. The fundamental problem of causal inference is that we can only observe one of the potential outcomes for a particular subject. The authors discuss how randomized experiments allow us to assess causal effects and then turn to observational studies. They lay out the assumptions needed for causal inference and describe the leading analysis methods, including, matching, propensity-score methods, and instrumental variables. Many detailed applications are included, with special focus on practical aspects for the empirical researcher.
Health professionals from a wide range of backgrounds apply auriculotherapy to successfully relieve chronic pain and treat addictions. The most popular book on the subject, this practical handbook combines information on Chinese and French systems of ear acupuncture to offer treatment plans for over 250 medical conditions. Presenting the ear reflex points based on extensive research conducted at the UCLA Pain Management Center, it provides a standardized auricular nomenclature system for designating different anatomical zones of the ear, and it represents each ear reflex point with both a number and an auricular zone location.
Background:
Anxiety and fatigue adversely affect women's postpartum recovery, but few effective non-pharmacological interventions are known to relieve these two common and unpleasant symptoms.
Objectives:
To examine the efficacy of an auricular acupressure intervention provided during early postpartum in reducing anxiety, fatigue levels, cortisol levels, blood pressure, and heart rate.
Design:
A single-blind, randomised controlled trial.
Setting:
A 40-bed postpartum unit.
Participants:
Women who underwent caesarean section were randomly allocated to two groups: intervention (auricular pressure, n=40), and control (usual care, n=40).
Methods:
The intervention group received auricular acupressure on the shenmen acupoint twice a day (9 AM and 5 PM), and the control group received usual postpartum care. Serum cortisol levels were assessed by immunochemiluminescence, with blood pressure and heart rate assessed by electric sphygmomanometer. Anxiety and fatigue symptoms were assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory and the Fatigue Continuum Form, respectively.
Results:
Of the 76 women who completed the study, those who received auricular acupressure had significantly lower mean cortisol levels (mean difference=4μg/dl, p<0.05), heart rate (mean difference=9.2 beats/min, p<0.001), anxiety symptoms (mean difference=3.8, p<0.01), and fatigue symptoms (mean difference=7.1, p<0.01) than women in the control group at 5 days postpartum.
Conclusions:
Auricular acupressure is an effective non-pharmacological method for reducing cortisol levels, heart rate, anxiety, and fatigue in early postpartum after caesarean section.
Purpose: The aim of this study was to identify the effects of auricular acupressure on nausea, vomiting and serum serotonin level in gynecological cancer patients with chemotherapy. Methods: The research was a randomized control group pretest-posttest design. Participants were 26 patients for the experimental group, and 26 patients for the control group. Auricular acupressure in Shen men, Occiput, Stomach and Sympathetic points was administered to those in the experimental group. Data were analyzed using x2-test, t-test, ANCOVA, and repeated measures of ANOVA. Results: The experimental group had reported significantly lower mean nausea NRS (Number Rating Scale), INVR (Index of Nausea, Vomiting, and Retching), and serum serotonin level than those in the control group. Conclusion: Results of the study show auricular acupressure is an effective nursing intervention for reducing chemotherapy-induced nausea, vomiting and serum serotonin level of gynecological cancer patients.
IntroductionThe incidence of vulvodynia in American women has been reported to be between 8.3% and 16%. However, there is no consistently effective standardized treatment for vulvodynia.AimTo determine the feasibility and potential effects of using a standardized acupuncture protocol for the treatment of women with vulvodynia.Main Outcome MeasuresThe primary outcome was vulvar pain, and sexual function was the secondary outcome. Pain was assessed by the Short-Form McGill Pain Questionnaire, and function was measured by the Female Sexual Function Index (FSFI).Methods
Thirty-six women with vulvodynia met inclusion criteria. The women were randomly assigned either to the acupuncture group or to the wait-list control group. The 18 subjects assigned to the acupuncture group received acupuncture two times per week for 5 weeks for a total of 10 sessions.ResultsReports of vulvar pain and dyspareunia were significantly reduced, whereas changes in the aggregate FSFI scores suggest significant improvement in sexual functioning in those receiving acupuncture vs. those who did not. Acupuncture did not significantly increase sexual desire, sexual arousal, lubrication, ability to orgasm or sexual satisfaction in women with vulvodynia.Conclusion
This was the first randomized controlled pilot study to examine the use of acupuncture for the treatment of vulvodynia. The acupuncture protocol was feasible and in this small sample appeared to reduce vulvar pain and dyspareunia with an increase in overall sexual function for women with vulvodynia. This study should be replicated in a larger double-blinded randomized controlled trial. Schlaeger JM, Xu N, Mejta CL, Park CG, and Wilkie DJ. Acupuncture for the treatment of vulvodynia: A randomized wait-list controlled pilot study. J Sex Med **;**:**–**.
Female sexual dysfunction has a known impact on the quality of life.
The purpose of this study was the translation and validation of an Iranian version of the Sexual Quality of Life questionnaire-Female (SQOL-F) in Iranian women.
A population sample of N = 2,675 women aged 17–67 years from Qazvin City of Iran and two clinical population samples (women with sexual dysfunctions N = 295 and women with type 2 diabetes N = 449) participated in the study. A self-constructed demographic questionnaire, the SQOL-F, the Short Form Health Survey (SF-36), and the Female Sexual Function Index (FSFI) were used for data collection.
Internal consistency and test–retest reliability were examined. Correlations between the SQOL-F, SF-36, and FSFI were assessed with convergent validity. Furthermore, known-groups comparison analysis was conducted to compare differences in SQOL-F scores between healthy women and those with sexual problems and diabetes. Confirmatory factor analysis assessed the factor structure of the SQOL-F.
Cronbach's alpha ranged from 0.84 to 0.98. Significant correlations between the SQOL-F, SF-36, and FSFI scores were found (ranging from r = 0.4 to r = 0.72). The SQOL-F scores were significantly different between women with and without a clinical condition (P < 0.05). A unifactorial model provided the best fit to the data.
The questionnaire represents a suitable measure to assess sexuality-related quality of life to sexual function in healthy women, as well as in women suffering from a chronic medical condition. Application of the scale to other clinical samples needs to be further explored.
Female sexual dysfunction (FSD) is a prevalent problem in the female population in Iran. A subjective assessment instrument that allows cross-cultural comparison of FSD is urgently needed.
The aims of the study were to translate, validate, and enhance cross-cultural comparability of an Iranian version (IV) of the Female Sexual Function Index (FSFI)-the IV-FSFI.
A total of 448 women (19-54 years, mean 29.7, standard deviation 7.3) from five different Iranian outpatient obstetrics and gynecology clinics were eligible for this study. The IV-FSFI was developed through forward and backward translation, revision by a research team, and a subsequent pilot study. After an interview for clinical diagnosis of FSD based on the Diagnostic and Statistical Manual of Mental Disorders, all participants completed the IV-FSFI for the validation study. Three hundred sixty-two women completed the IV-FSFI again, 4 weeks after the first visit.
Test-retest reliability was determined by Pearson's product-moment correlations. Reliability was tested using Cronbach's alpha coefficient. Construct validity was evaluated by principal component analysis using varimax rotation and by subsequent confirmatory factor analysis (CFA). Discriminant validity was assessed with between-groups analysis of variance.
The overall test-retest reliability coefficients were high for each domain of the IV-FSFI (r ranging from 0.73 to 0.86) and the internal consistencies within the acceptable range (α from 0.72 to 0.90). Principal component analysis with varimax rotation revealed a best fitting five-factor structure similar to the original FSFI (χ(2) = 2.1, degree of freedom = 17, P < 0.001). CFA confirmed the underlying domain structure, supporting the factorial validity of the IV-FSFI.
In conclusion, the newly developed IV-FSFI has demonstrated to be a reliable and valid instrument with good psychometric properties that allows a quick and accurate preliminary screening of women with unknown sexual health status in clinics and other medical settings.
To evaluate the effects of early pelvic floor muscle training after vaginal delivery on sexual function.
Prospective randomized study.
Urogynecology clinic of a tertiary medical center in Istanbul, Turkey.
Total of 75 primiparous women.
Pelvic floor-muscle strength was assessed during rest and straining in primiparous women in their 4th postpartum month, after which the women were randomized into training (n = 37) and control (n = 38) groups. Patients were re-evaluated in the 7th postpartum month.
Female sexual function and pelvic muscle strength scores.
Desire, pain and total female sexual index scores were significantly higher in the 7th month compared to 4th month in both groups (p < 0.05). However, sexual arousal, lubrication, orgasm, and satisfaction scores were improved in the 7th month in the training group (paired t-test, p < 0.001), but not significantly in the control group (p > 0.05). All domains except satisfaction were significantly higher in the training group compared with the controls. Pelvic floor-muscle strength was found to be increased in the 7th month in the training group (Wilcoxon rank test, Z = 4.123, p < 0.001), whereas there was no significant difference between the 4th and 7th month measurements in the controls (p > 0.05).
Pelvic floor-muscle training improves pelvic floor-muscle function, and starting after the puerperal period, exercise appears to have positive effects on female sexual function.
Provoked vestibulodynia (PVD) is a distressing genital pain condition affecting 12% of women. Treatment modalities vary and although vestibulectomy has the highest efficacy rates, it is usually not a first-line option. Acupuncture has a long history in the traditional Chinese medicine (TCM) system and operates on the premise that pain results from the blockage or imbalance of important channels. The main principle of treatment is to move Qi and blood to cease genital pain.
To explore effect sizes and feasibility in a pilot study of acupuncture for women with PVD.
Eight women with PVD (mean age 30 years) underwent 10 1-hour acupuncture sessions. Specific placement of the needles depended on the woman's individual TCM diagnosis. TCM practitioners made qualitative notes on participants' feedback after each session. Main Outcome Measures. Self-reported pain (investigator-developed), pain-associated cognitions (Pain Catastrophizing Scale [PCS], Pain Vigilance and Awareness Questionnaire), and sexual response (Female Sexual Function Index) were measured before and after treatment sessions 5 and 10. Qualitative analyses of TCM practitioner notes were performed along with one in-depth case report on the experience of a participant.
A repeated measures analysis of variance revealed significant decreases in pain with manual genital stimulation and helplessness on the PCS. An examination of effect sizes also revealed strong (though nonsignificant) effects for improved ability to have intercourse and sexual desire. Qualitative analyses were overall more positive and revealed an improvement in perceived sexual health, reduced pain, and improved mental well-being in the majority of participants.
Effect sizes and qualitative analyses of practitioner-initiated interviews showed overall positive effects of acupuncture, but there were statistically significant improvements only in pain with manual genital stimulation and helplessness. These findings require replication in a larger, controlled trial before any definitive conclusions on the efficacy of acupuncture for PVD can be made.
The development of a 10-item self-report scale (EPDS) to screen for Postnatal Depression in the community is described. After extensive pilot interviews a validation study was carried out on 84 mothers using the Research Diagnostic Criteria for depressive illness obtained from Goldberg's Standardised Psychiatric Interview. The EPDS was found to have satisfactory sensitivity and specificity, and was also sensitive to change in the severity of depression over time. The scale can be completed in about 5 minutes and has a simple method of scoring. The use of the EPDS in the secondary prevention of Postnatal Depression is discussed.