Acupressure to improve sleep quality of older people in residential aged care: a randomised controlled trial protocol

Abstract

Background:
Sleep disturbance in older people is an important health issue that is associated with many other health problems. Effective interventions are required to address sleep problems in this group. Acupressure has been suggested as a potential therapeutic technique to improve sleep. The aim of this study is to evaluate the effects of an acupressure intervention on sleep quality, anxiety, depression, and quality of life among older persons in residential aged care facilities within an Australian context.

Methods/design:
This is a randomised controlled trial with two parallel groups in a pre- and post-test study. Study participants will be older people living in residential aged care facilities. They will be assigned to intervention and control groups using computer-generated random numbers. The intervention group will receive 12-min acupressure three times per week for four consecutive weeks, applied on three acupoints: HT7, PC6, and SP6. The control group will receive only routine care. The primary outcome measure is sleep quality, and secondary outcomes include anxiety, depression, and quality of life. Data will be collected before the intervention, immediately after the end of the intervention, and 2 weeks after the intervention.

Discussion:
This study targets a poorly met healthcare need of older people who are experiencing sleep disturbance and its negative consequences. To the researchers' knowledge, this is the first study evaluating acupressure in an Australian aged care context, using specific acupoints and a standardised acupressure protocol. If the results show positive outcomes, acupressure could be used to manage sleep disturbances for older people in the Australian context as well as in the global ageing population. This will contribute to reducing negative consequences of sleep disturbance and use of sleep medications.

Trial registration:
Australian New Zealand Clinical Trials Registry: ACTRN12619000262101. Registered on 20 February 2019.

Full text

S T U D Y P R O T O C O L Open Access
Acupressure to improve sleep quality of
older people in residential aged care: a
randomised controlled trial protocol
Nant Thin Thin Hmwe
1*
, Graeme Browne
1
, Lyndall Mollart
1
, Viv Allanson
2
and Sally Wai-Chi Chan
3
Abstract
Background: Sleep disturbance in older people is an important health issue that is associated with many other
health problems. Effective interventions are required to address sleep problems in this group. Acupressure has been
suggested as a potential therapeutic technique to improve sleep. The aim of this study is to evaluate the effects of
an acupressure intervention on sleep quality, anxiety, depression, and quality of life among older persons in
residential aged care facilities within an Australian context.
Methods/design: This is a randomised controlled trial with two parallel groups in a pre- and post-test study. Study
participants will be older people living in residential aged care facilities. They will be assigned to intervention and
control groups using computer-generated random numbers. The intervention group will receive 12-min
acupressure three times per week for four consecutive weeks, applied on three acupoints: HT7, PC6, and SP6. The
control group will receive only routine care. The primary outcome measure is sleep quality, and secondary
outcomes include anxiety, depression, and quality of life. Data will be collected before the intervention,
immediately after the end of the intervention, and 2 weeks after the intervention.
Discussion: This study targets a poorly met healthcare need of older people who are experiencing sleep
disturbance and its negative consequences. To the researchers’knowledge, this is the first study evaluating
acupressure in an Australian aged care context, using specific acupoints and a standardised acupressure protocol. If
the results show positive outcomes, acupressure could be used to manage sleep disturbances for older people in
the Australian context as well as in the global ageing population. This will contribute to reducing negative
consequences of sleep disturbance and use of sleep medications.
Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12619000262101. Registered on 20
February 2019.
Keywords: Acupressure, Older people, Aged care, Residential aged care facilities, Sleep disturbance, Sleep quality
Introduction
Sleep disturbances increase with advancing age, with the
prevalent rate approaching 50% in older people aged 65
and above [1]. Sleep disturbances in older persons are
associated with poor health status, cognitive decline, de-
pression, poor quality of life (QoL) and higher risk of
falls [1,2]. Recent systematic reviews and meta-analyses
found that sleep disturbances contributed to higher risk
of dementia [3], mental illnesses including anxiety and
depression [4], hypertension [5], and cardiovascular dis-
ease [6]. Sleep disturbances are also found to have a bi-
directional relationship with depression and anxiety [7].
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* Correspondence: nantthinthin.nantthinthinhmwe@uon.edu.au
1
School of Nursing and Midwifery, The University of Newcastle, University
Drive, Callaghan, NSW 2308, Australia
Full list of author information is available at the end of the article
Hmwe et al. Trials (2020) 21:360
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Insomnia and sleep problems were related to high level
of anxiety and depression; on the other hand, anxiety
and depression were related to insomnia [7].
These health and psychosocial issues are especially
pertinent for older people in residential care. The preva-
lence of sleep disturbance is higher among older people
in residential care than among those living in the com-
munity [8–11]. A study conducted in Spain showed that
a high percentage of nursing home residents (72.1%)
were poor sleepers, and poor sleep quality was found to
be correlated with decline in functional status [10]. In a
European study, the prevalent rate of insomnia in long-
term care residents was 24% (ranging from 13% to 30%)
[8]. Authors of a narrative review of sleep among long-
term care residents in China reported that the preva-
lence of poor sleep quality ranged from 33% to 73% [9].
In Australia, 47.3% of residents in aged care had poorer
night-time sleep quality [12]. The high prevalence of
sleep problems in this population is a global health con-
cern that needs to be addressed. Promoting sleep quality
may have a positive impact on its associated conditions
such as depression, anxiety, and poor QoL.
Background
Sleep disturbance in the older population is a worldwide
health issue that is associated with many health condi-
tions and increased healthcare burdens [1,13]. Sleep dis-
turbances comprise a broad range of clinical conditions:
difficulty in initiating or maintaining sleep, excessive
daytime sleepiness, and disrupted sleep–wake patterns
[7,14]. Sleep disturbance in older people is a multifac-
torial geriatric health issue that calls for a comprehen-
sive treatment approach, with consideration of multiple
risk factors such as comorbid diseases, side effects of
medications, and psychosocial factors [1,13]. Integrating
conventional medical treatment with complementary
therapy to address this clinical issue might be beneficial.
Sleep disturbance in older people is often treated with
medications, which have potential adverse effects: drow-
siness, poor concentration, loss of memory, and drug de-
pendence [15,16]. These adverse effects contribute to
risks of falls, accidents, and cognitive impairment with
long-term use of sleep medications [13,17]. To avoid
the adverse effects of sleep medications, a non-
pharmacological treatment approach has been recom-
mended to manage sleep disturbances in older people
[17,18]. Use of complementary and alternative medicine
(CAM) may be beneficial for sleep improvement in older
people.
Acupressure, application of fingers or thumb pressure
on acupuncture points, is a CAM modality which has
potential to improve sleep quality [19–21]. Previous re-
search and reviews have shown that acupressure im-
proved sleep quality with no reported adverse effects
[19–24]. In addition, acupressure may have potential to
reduce the frequency and amount sleep medications
used [23,25]. This can further reduce the cost and side
effects of sleep medications. There is also some evidence
that acupressure may improve depression [19], anxiety
[26] and QoL [21]. However, some studies have meth-
odological limitations as well as variation in acupressure
techniques and the selection of acupoints [19,20,26].
Future well-designed studies, using standardised treat-
ment protocols, are required to provide evidence of acu-
pressure’s usefulness in clinical practice.
Acupressure is a simple technique which can be ad-
ministered by nurses with minimal training. Integrating
acupressure into aged care settings may be beneficial to
promote sleep quality and wellbeing, without having
harmful side effects. However, the acceptability and ef-
fectiveness of acupressure on sleep improvement re-
mains unclear in the Australia aged care context. The
majority of the acupressure studies were carried out in
Asian countries (in Taiwan, China, and Hong Kong),
and the participants were Chinese who might have had
beliefs in traditional Chinese medicine (TCM) [19,20].
There is a paucity of studies evaluating the outcomes of
acupressure in Western countries, including Australia
[19,20]. Acupressure studies conducted in Western pop-
ulations would enhance the generalisability of the find-
ings. Thus, it is timely to test the efficacy of a
standardised acupressure intervention protocol, with
well-defined techniques applied on specific acupoints, in
residential aged care facilities (RACFs) within the
Australia context.
In this study, we focus on sleep quality as the primary
outcome because sleep disturbance in this age group is a
significant issue which has negative impacts on health sta-
tus. We will measure anxiety, depression, and QoL as sec-
ondary outcomes that are associated with sleep
disturbances. The findings of this study will provide im-
portant implications and recommendations for future im-
plementation of acupressure intervention in the
Australian aged care context, as well as in the worldwide
general population with sleep disturbances.
Acupressure for sleep
Acupressure is the stimulation of acupuncture points
(acupoints) on the meridian lines using finger or thumb
pressure [27]. The purpose of acupressure is to regulate
the vital energy (known as Qi) that maintains the per-
son’s health and wellbeing [27]. Manual stimulation of
acupoints helps release muscle tension, promotes blood
circulation, and strengthens immunity [27,28]. In the
TCM perspective, health is considered as having the
normal flow of a vital energy and balance between Yin
and Yang [29]. When Qi flows freely, the person is
healthy and well-balanced. If there is insufficient Qi,or
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normal movement of Qi is impaired, dysfunction occurs, and
then physical, emotional, and mental illnesses develop. In the
condition of sleep disturbances, it is a result of internal dis-
harmony in Qi flow, Yin and Yang imbalance, and dysfunc-
tion of the internal organs [30]. Application of acupressure
regulates Qi flow within the body or in a specific organ, re-
storing good health and improving sleep quality [27,31].
Acupoints for sleep improvement
In TCM, sleep problems are associated with dysfunction
of the heart and other organs, including the spleen, liver,
kidneys, and stomach [24,30]. Therefore, selecting the
major acupoint on the heart meridian (HT7) and add-
itional acupoints that are linked to other internal organs
(PC6 and SP6) may enhance sleep quality. The acu-
points—namely, Shenmen (HT7), Neiguan (PC6), and
Sanyinjiao (SP6)—have commonly been used to improve
sleep quality [19,20,32,33].
Shenmen (HT7) is an important acupoint along the
heart meridian that passes through and ends in the heart
[24]. Shenmen is described as the ‘spirit gate’that is a path-
way related to vitality and stabilises mental state, and it is be-
lieved to calm the nerves and ease the mind [31]. In TCM,
dysfunction of the heart is thought to be a major cause of
sleep disturbance. Therefore, pressure applied to the Shen-
men, the major point of the heart channel, is thought to
regulate sleep function [20,31].AsshowninFig.1,HT7is
located on the palmar wrist crease at the depression radial to
the proximal border of the pisiform bone [34].
Neiguan (PC6) is the connecting point of the pericar-
dial meridian (PC) that controls the functions of the
heart and respiration [35]. This acupoint is commonly
used for nausea and vomiting, but it can be used to treat
illnesses related to the heart, lungs, and stomach and
mental problems. The Neiguan regulates the heart Qi,
opens the chest, harmonises the stomach, and calms the
spirit. Acupressure on applied on Neiguan could relieve
insomnia, dyspnoea, cough, tightness of chest, nausea,
vomiting, motion sickness, headache, depression and
anxiety [35,36].
In TCM, dysfunctions of the heart and stomach could
be related to sleep disturbances [30]. Thus, the Neiguan
is a useful point that regulates normal functions of the
heart and stomach, thereby relieving sleep problems and
associated symptoms. PC6 is located at the anterior as-
pect of the forearm, between two tendons (the palmaris
longus and the flexor carpi radialis), 2-cun proximal to
the palmar wrist crease (shown in Fig. 1)[34].
Sanyinjiao (SP6) is one of the commonly used acu-
points because it is located at the intersection of three Yin
meridians: the spleen, kidney and liver meridians [35]. This
acupoint can be used to treat the conditions related to uro-
genital disorders, menstruation, childbirth, menopause, in-
digestion, insomnia and emotional imbalances [35,36].
According to TCM, sleep disturbance is also caused dys-
functions of spleen, kidney and liver; thus, stimulating the
Sanyinjiao is commonly applied to improve sleep [24,30].
SP6 is located on the tibial aspect of the leg, posterior to
the medial border of the tibia, 3-cun superior to the prom-
inence of the medial malleolus (shown in Fig. 1)[34].
TCM emphasises the individualised nature of therapy,
and therefore individualised treatments are given depend-
ing on the patient’sconditions[31,36]. However, in re-
search and clinical practice, standardised acupressure
protocols are required, with clearly defined technique and
specific acupoints. In this study, finger or thumb pressure
applied on three specific acupoints—HT7, PC6 and SP6—
is expected to produce a positive effect on sleep quality.
Study aim and hypotheses
This study aims to evaluate the effects of an acupressure
intervention, using three specific acupoints (HT7, PC6
and SP6), on sleep quality, anxiety, depression, and QoL
of older people in RACFs in Australia.
Hypotheses
After the intervention, compared with the control
group, the experimental group receiving acupressure
would have:
Fig. 1 Location of selected acupoints
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1. Significant improvement of sleep quality,
2. Significant reduction of level of depression and
anxiety, and
3. Significant improvement of QoL.
Methods/design
Study design
A randomised controlled trial with two parallel groups,
pre- and post-test design, is proposed. The study proto-
col followed the Standard Protocol Items: Recommenda-
tions for Interventional Trials (SPIRIT) checklist
(Additional File 1). The study participants will be ran-
domly assigned to the intervention group, receiving 12-
min acupressure sessions and routine care, or the con-
trol group, receiving routine care only.
Setting and participants
This study will be conducted in three RACFs (RACFs 1,
2 and 3) in New South Wales State, Australia. The se-
lected study venues are facilities accredited by the Aged
Care Quality and Safety Commission, Australia. These
facilities offer general healthcare for the residents and
specialised aged care services, such as dementia care and
palliative care. Study participants will be older people
residing in the study venues.
Inclusion and exclusion criteria
The inclusion criteria to participate in this study are (i)
aged 65 and above, (ii) a resident of an aged care facility
or a retirement village, (iii) have self-reported poor sleep
quality, (iv) able to communicate, and (v) able to give writ-
ten consent to participate and do so. Self-reported poor
sleep quality will be identified on the basis of residents’
subjective complaint of disrupted sleep, having sleep prob-
lems or poor sleep quality. When potential participants
express interest in the study, the researcher will ask them
whether they have sleep problems or disturbed sleep.
The exclusion criteria are (i) severe cognitive impair-
ment that would limit the accuracy of assessment; (ii)
amputation or recent fracture of upper or lower limbs,
because the selected acupoints are located on both
hands and legs; (iii) severe illness, presence of blood
clotting disorders such as thrombophlebitis, or bleeding
disorder such as haemophilia to avoid potential compli-
cations; (iv) currently taking blood thinning medication,
anti-coagulants and anti-clotting agents; and (vi) pres-
ence of skin lesions, infection or inflammation near se-
lected acupoints. Cognitive function level will be
determined on the basis of the Mini Mental State Exam-
ination (MMSE) record used in the facility. An MMSE
score of 9 or lower is considered as severe cognitive im-
pairment in older populations [37].
Sample size estimation
The sample size estimation is based on a previous study
that indicated statistical significance in sleep quality be-
tween intervention and control group [23]. The mean
difference of sleep quality (Pittsburgh Sleep Quality
Index [PSQI] score) between groups was 5, and the
pooled standard deviation was 6.35. To detect a mean
difference of 5 points (assuming a standard deviation of
6.35), 26 participants in each group are required for a
power of 0.80 and P= 0.05. Considering a 10% attrition
rate, 29 participants in each group, with a total of 58
participants, are required.
Randomisation
Block randomisation with 1:1 allocation ratio will be
used. Block sizes of 4 and 6 will be used. The random
sequence numbers will be produced by using an internet
tool (www.sealedenvelope.com). Sealed envelopes with
sequential numbering will be used to conceal group allo-
cation. Blinding is not possible in this study, because it
has limited funding to employ assistants for data collec-
tion and acupressure intervention. Therefore, the pri-
mary researcher will perform the acupressure and will
collect and analyse the data.
Acupressure intervention and routine care
The participants assigned in the intervention group will
receive acupressure and routine care offered in the se-
lected RACFs. The control group will receive routine
care only. During the intervention period, participants in
both groups will be allowed to take prescribed medica-
tions and go for their routine daily activities. The re-
search team does not control any routine activity and
prescribed treatment, including sleep medication.
Acupressure intervention
The acupressure intervention runs for 4 weeks, with 12-
min session to be given three times per week. The acu-
pressure intervention protocol has been developed on the
basis of TCM concepts, research evidence [22,23,38,39],
and systematic and integrative reviews on acupressure
studies [19,20,32]. One of the supervisors is a qualified
acupressure practitioner. She has supervised the design of
the acupressure intervention protocol.
The intervention ‘dosage’is based on the findings of
systematic and integrative reviews [19,20,32]. System-
atic reviews suggested that acupressure was most effect-
ive when applied three or more times per week for a
minimum of 3 weeks [20], and a 4-week duration was
most commonly used [32]. Finger pressure applied on
each acupoint should be a minimum of 1 min [20], and
2–3 min duration applied on each point [19,32]. In this
study, pressure will be applied for 2 min on each acu-
point—HT7, PC6 and SP6—on both hands and legs,
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thus a total of six points for both sides with 12-min dur-
ation. Table 1shows the acupressure intervention
protocol.
The student researcher (first author) will perform the
acupressure intervention. She has experience in general
nursing practice and nursing education. She has received
training in acupressure technique from a qualified Chin-
ese medicine physician and has performed similar acu-
pressure intervention in her previous postgraduate
research. To enhance her skills in acupressure for the
present study, she attended acupressure practitioner
training in Australia. During the training period, she had
practised accuracy of acupoint location and acupressure
technique with healthy persons, under supervision of the
acupressure trainer, who has extensive experience in
acupressure practice and training. Before conducting the
acupressure intervention sessions, she rehearsed the acu-
point locations and acupressure technique with healthy
volunteers, which is verified by the co-researcher, who is
expert in acupressure.
To ensure intervention fidelity, the student researcher
will perform acupressure following the intervention
protocol (Table 1). She will keep field notes that record
the date and time of each acupressure session, as well as
the observation of participants’general condition during
each acupressure session. To minimise potential discom-
fort of participants during the treatment, the student re-
searcher will assess the participant’s response, and the
intensity of pressure will be adjusted according to the
person’s level of tolerance. She will also observe any
issue or adverse event that occurs during the interven-
tion period. If any untoward effect occurs, the student
researcher will stop doing acupressure on the affected
person and report to the nurse in charge and the facility
manager. The student researcher and supervisors will
have regular meetings to discuss the progress of the
study, as well as any issues and concerns related to the
study.
Routine care
The control group will receive routine care offered in
the selected aged care centre (prescribed medications
and routine activities). Routine care is the care offered to
the participants according to the existing standard prac-
tices established in a particular care setting [40]. Routine
care is often used for control groups, to compare a spe-
cific intervention (e.g., acupressure) with the existing
practice in a selected setting [40]. In this study setting,
the control group will be given daily routine care, nurs-
ing care, general healthcare, and specialised care based
on the individual’s needs. The care given to control
group will be equal to intervention group, except for the
acupressure.
Recruitment
The recruitment procedure will be carried out by the
student researcher. The recruitment poster will be
posted in the facility to advertise the research project,
and flyers will be placed in reception and common areas
of the facility. The student researcher will also promote
the study during their routine social activities. She will
present the study and then ask the potential participants
for their expression of interest, either verbally or by con-
tacting her via telephone or email. When the residents
contact the student researcher and express interest in
participating, the student researcher will explain the de-
tails of study procedures and provide them the partici-
pant information sheet and consent form. The
researcher will assure that their participation in the
study or decision to decline to participate will not affect
Table 1 Acupressure intervention protocol
Acupressure sessions and length of intervention •12-min session, three times per week for 4 weeks
•Daytime (9 a.m.–5 p.m.), following the convenient
time for study participants
Selection of acupoints 1. Shenmen (HT7) on both hands
2. Neiguan (PC6) on both hands
3. Sanyinjiao (SP6) on both legs
Sequence and time of acupressure application per point Apply finger pressure for 2 min on each point with
the following sequence:
1. PC6 in left hand
2. PC6 in right hand
3. HT7 in left hand
4. HT7 in right hand
5. SP6 on left leg
6. SP6 on right leg
Acupressure technique •Apply consistent finger or thumb pressure on each
point in circular motion
•Circular motion in clockwise for 1 min and counter-
clockwise for 1 min
•Intensity of pressure adjusted according to the
person’s level of tolerance
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the services they receive in the facility. If they agree to
participate, information about inclusion and exclusion
criteria will be identified on the basis of their medical re-
cords. Residents who give consent and meet the inclu-
sion criteria will be enrolled in the study, given with a
specific identification number (e.g., 001, 002). They will
then be assigned to the intervention or control group,
using random sequence numbers generated by the inter-
net tool.
Data collection
Data collection will be carried out by the researcher for
pre-test, post-test, and 2-week post-test. The data collec-
tion timeline is shown in Table 2. The baseline data col-
lection (pre-test, T0) will be conducted before
commencing the acupressure intervention, using a struc-
tured questionnaire for demographic and clinical data and
validated assessment tools for sleep quality, depression,
anxiety and QoL. Demographic and clinical data include
age, sex, marital status, number of children, education
level, residential status, length of stay in facility, source of
funding, presence of chronic disease, and medications.
The outcome assessments will be conducted at the
end of intervention (post-test, T1) and 2 weeks post-
intervention (post-test, T2). The participants will receive
only routine care after the intervention period. The pur-
pose of the follow-up test (T2) is to assess whether the
treatment effect of acupressure can be retained 2 weeks
after the intervention. For the control group, baseline
and outcome data (T0, T1 and T2) will be collected
using the same set of questionnaires and following the
same time frame as in the intervention group. The stu-
dent researcher will provide the assessment tools to the
participants and assist them in completing the question-
naires if needed.
Outcome assessments
The primary outcome for the acupressure intervention is
sleep quality, which will be measured using the PSQI
[41] and an objective sleep measurement device (Acti-
Graph, Pensacola, FL, USA). The secondary outcome
measures include anxiety, depression and QoL. The
Hospital Anxiety and Depression Scale (HADS) [42] will
be used to measure anxiety and depression, and the brief
Older People’s Quality of Life Questionnaire (OPQOL-
Brief) [43] will be used to measure QoL.
Pittsburgh Sleep Quality Index
The PSQI measures a person’s subjective sleep quality
over the previous 1-month time period. It consists of 19
items with seven sub-scores: subjective sleep quality,
sleep latency, sleep duration, sleep efficiency, daytime
dysfunction, sleep disturbances and use of sleeping med-
ications [41]. The total score ranges from 0 to 21; higher
scores indicates worse sleep quality, and a score greater
than 5 indicates poor sleep quality [41].
The original version of the PSQI is a valid and reliable
tool that is widely used to measure subjective sleep qual-
ity, with Cronbach’sαof 0.83 in healthy adults and indi-
viduals with sleep complaints and psychiatric symptoms
[41]. The construct validity and internal consistency reli-
ability in older adults was shown to be adequate, with
the Cronbach’sα= 0.69 in older men [44] and α= 0.72
in older women [45].
In this study, sleep quality will be assessed before,
immediately after and again 2 weeks after the inter-
vention. To be consistent with the period between
Table 2 Data collection timeline
Stages Enrolment Pre-test
T0
4-Week acupressure intervention Post-test, T1 Follow-up, T2
Time point Week
0
Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8
Recruitment and consent 4–6 weeks
Baseline assessment:
- Demographic and clinical data
- ActiGraph
- PSQI, HADS, OPQOL-Brief
X
Intervention:
IG: acupressure + routine care
CG: routine care
XXXX
Post-test outcome assessment:
- ActiGraph
- PSQI, HADS, OPQOL-Brief
X
Follow-up assessment:
- ActiGraph
- PSQI, HADS, OPQOL-Brief
X
CG Control group, HADS Hospital Anxiety and Depression Scale, IG Intervention group, OPQOL-Brief Older People’s Quality of Life questionnaire–brief version, PSQI
Pittsburgh Sleep Quality Index
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ratings, the time frame of the PSQI is modified as
‘during past two weeks’instead of ‘during past
month’. The modified version of the PSQI assesses
sleep quality within the past 2 weeks.
Objective sleep measurement (ActiGraph)
The actigraphy device (ActiGraph GT9X Link) is
equipped with a sensor that measures objective sleep
patterns of a person. The ActiGraph is found to be a
valid tool to determine the changes in sleep quality in-
duced by specific intervention; therefore, it is suggested
as a useful device for intervention studies [46]. To obtain
reliable sleep data, the participants need to wear the de-
vice for a 1-week period [46,47]. Therefore, the Acti-
Graph data will be recorded for 7 days before the
intervention (T0), after the intervention (T1), and for 2
weeks post-intervention (T3). Participants will be asked
to wear the device on the dominant wrist for 7 days and
nights continuously, with it to be taken off only when
showering. The data recorded by the ActiGraph will be
downloaded and analysed using the ActiGraph software
(ActiLife 6).
Hospital Anxiety and Depression Scale
The HADS is a tool for detecting emotional states of de-
pression and anxiety in an adult population, and it is rec-
ommended for use in examining changes over time
through intervention trial [42,48]. It includes 14 items:
seven items for anxiety and seven for depression. The
HADS uses a 4-point Likert scale (0–3) for each item. The
total score of anxiety and depression subscales ranges
from 0 to 21; a higher score indicates higher level of de-
pression or anxiety [42]. The HADS has shown good psy-
chometric properties with good internal consistency in
older adult samples: α= 0.84 for the anxiety subscale, and
α= 0.75 for the depression subscale [48].
Brief Older People’s Quality of Life Questionnaire
The OPQOL-brief is a short version of the 35-item
OPQOL questionnaire [43]. The total score ranges from
13 to 65; a higher score represents higher QoL. The
OPQOL-brief was shown to be a reliable tool (α= 0.85),
and it is a suitable tool for outcome assessment of social
and health interventions in older people [43].
Data analysis plan
Data will be analysed using IBM SPSS Statistics version
24.0 software (IBM, Armonk, NY, USA). The researcher
will perform data entry using participants’code num-
bers. The data will be explored and assessed for missing
values, outliers, extreme values and normal distribution.
Descriptive statistics will be used to explore baseline
data. The generalised estimating equation (GEE) for re-
peated measurements will be used to examine the
intervention effects on sleep quality, depression, anxiety
and QoL. The primary outcome will be the treatment ef-
fect of acupressure on the post-treatment (T1) sleep
quality scores measured by the PSQI and the ActiGraph.
The post-treatment scores for the HADS and QoL will
be used as secondary outcomes. The outcome data mea-
sured at 2-week follow-up will be analysed to determine
the treatment effect of acupressure on the outcome vari-
ables (PSQI, ActiGraph, HADS and QoL scores) 2 weeks
after the intervention.
Adjusted analyses will be conducted for age group; sex;
use of sleep medication; and baseline PSQI, HADS and
QoL scores. Sub-group analyses will be conducted to deter-
mine the differences in treatment effect of acupressure
based on age group (65–85, 85–100, > 100 years) and use
of sleep medication (yes/no). The correlation between out-
come variables will be analysed (baseline, post-treatment,
and 2-week follow-up), using Pearson or Spearman rank-
correlation, depending on whether the data meet statistical
assumptions. The statistical significance will be P< 0.05.
The intention-to-treat method will be used that analyses
participants according to their treatment allocation, regard-
less of deviation from the intervention protocol [49].
Missing-at-random assumption will be used to handle
missing data in GEE analysis. The study flow diagram is
showninFig.2.
Ethical consideration
This study will be conducted with approval from the
University Human Research Ethics Committee, granted
on February 2019 (approval reference no. H-2018-0345).
Permission and organisational consent will be obtained
from the director or manager of the facilities. This study
will be conducted following the ethical standards estab-
lished by the National Health and Medical Research
Council, Australia [50]. The researchers will ensure that
participation in this study is on a voluntary basis, and
the participants can withdraw from the study at any time
before completion of the study without any impact on
the care they receive. Residents who agree to participate
will be required to sign a written consent form before
enrolling in the study. Participants’confidentiality will
be ensured by using identification code numbers. Partici-
pants’consent forms and completed demographic data
and assessment tools will be stored in a locked office
cabinet that can be accessed only by the student re-
searcher and supervisors involved in the study. All elec-
tronic information and files containing electronic data
will be saved on a password-secured computer.
Trial registration
This study is prospectively registered in the Australian
New Zealand Clinical Trials Registry (ACTR
N12619000262101; registered on 20 February 2019). At
Hmwe et al. Trials (2020) 21:360 Page 7 of 10
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the completion of the study, a summary of the results
and changes from initial protocol will be updated in the
trial registry/ (http://www.anzctr.org.au/ACTRN1261
9000262101.aspx).
Discussion
This study is designed to investigate the effects of an acu-
pressure intervention on sleep quality and associated con-
ditions, namely depression, anxiety, and QoL, among
older people living in RACFs in an Australian context. To
the researchers’knowledge, this is the first study evaluat-
ing the outcomes of an acupressure intervention in an
Australian aged care context. This study uses a well-
defined acupressure intervention protocol, focusing on
three specific acupoints—HT7, PC6 and SP6—for pro-
moting sleep quality. In addition, this study uses both sub-
jective and objective sleep measurements (questionnaire
and ActiGraph), which can provide a valid outcome of
sleep quality. The secondary outcomes for depression,
anxiety, and QoL are measured using the valid and reliable
assessment tools. The findings from this study will provide
good evidence of the usefulness and effectiveness of
acupressure regarding the sleep quality and wellbeing of
older people in the Australian context.
With regard to participant characteristics, Australian
older people living in aged care facilities or retirement
villages are aged 65 and above and have diverse socio-
demographic backgrounds. They are living with chronic
conditions and taking multiple prescribed medications.
The characteristics of the study sample are similar to the
wider population in RACFs. The study venues are also
representative of the Australian aged care context. To
ensure recruiting of representative samples, the student
researcher will promote the project and provide study
information to potential participants while the residents
are attending their routine activities in the study venues
(e.g., morning exercise, afternoon tea, craft sessions). She
will also connect with facility staff and the care team to
get support for recruiting participants.
When analysing the outcome data, robust statistical
methods will be used, including adjusted and sub-group
analyses. There may be correlation between outcome
variables, such as improvement of sleep quality may be
correlated with improvement in depression, anxiety, and
QoL. Therefore, we will conduct correlation analysis of
Fig. 2 Study flow diagram
Hmwe et al. Trials (2020) 21:360 Page 8 of 10
Content courtesy of Springer Nature, terms of use apply. Rights reserved.

outcome measures, and the results will be discussed fur-
ther in reporting the findings in a paper. This study will
not include a cost-utility analysis. If the older people
have better sleep, it could lead to better wellbeing and
less dependence on medication, and it may reduce some
healthcare costs.
Stimulating acupoints using finger or thumb pressure
is a simple technique that is easy to learn. Nurses, care-
givers and even family members can learn basic acupres-
sure techniques and apply acupressure for older people.
Therefore, integration of acupressure in aged care and
clinical practice is feasible and could be beneficial for
promoting sleep and wellbeing of older people and the
general population.
Limitations of the study
The researchers and participants are not blinded to the
study. The student researcher will carry out data collec-
tion, acupressure intervention, and data analysis with guid-
ance from her doctoral degree supervisors. The researcher
will comply with the codes of conduct and research integ-
rity to minimise study bias. She will administer the ques-
tionnaires without influencing participants’responses to
the questions. The identification code numbers will be
used throughout collecting and analysing data.
Sham intervention and attention control are not used
for the comparison group. Because only one researcher
will perform acupressure, it is not possible for her to
perform sham acupressure or attention control activities
concurrently with the acupressure group. This is a study
for doctoral program project that evaluates the potential
efficacy of acupressure in promoting sleep quality and
associated outcomes. If the intervention is found to be
effective, further funding will be sought for a large-scale
study, with sham intervention and blinding procedures.
Trial status
Participant recruitment commenced in March 2019
(protocol version 3, dated 26 November 2018). Recruit-
ment has been slower than expected. Many residents had
little knowledge of acupressure, and they had low interest.
Some of them were unable to commit their time to the
intervention, and some interested participants did not
meet eligibility criteria. We extended the recruitment sites
in RACF 2 (protocol version 4, dated 29 May 2019) and
RACF 3 (protocol version 5, dated 23 July 2019). The pro-
ject has been completed in 15 April 2020. The study find-
ings will be published in journals and presented at local
and international conferences.
Conclusion
This study targets a poorly met healthcare need of older
people who are experiencing sleep disturbance and its
negative consequences. Acupressure is a simple
technique that can be easily applicable in practice set-
tings to promote the sleep and wellbeing of older people.
If the results show the usefulness of acupressure to pro-
mote sleep and wellbeing, it will provide broad implica-
tions for the use of acupressure in aged care and other
clinical practices. The standardised acupressure protocol
and specific acupoints used in this study may contribute
to the further development of acupressure intervention
for promoting sleep and wellbeing. Therefore, this
study’s findings will be applicable to the global ageing
population as well as those in the general population
who are experiencing sleep disturbances.
Supplementary information
Supplementary information accompanies this paper at https://doi.org/10.
1186/s13063-020-04286-2.
Additional file 1. SPIRIT checklist.
Abbreviations
CAM: Complementary and alternative medicine; GEE: Generalised estimating
equations; HADS: Hospital Anxiety and Depression Scale; HT: Heart meridian;
MMSE: Mini Mental State Examination; OPQOL: Older People’s Quality of Life
Questionnaire; PC: Pericardial meridian; PSQI: Pittsburgh Sleep Quality Index;
QoL: Quality of life; RACF: Residential aged care facility; SP: Spleen meridian;
SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials;
TCM: Traditional Chinese medicine
Acknowledgements
The authors acknowledge the postgraduate research scholarship offered to
the first author: UNIPRS and UNRSC 2017 from The University of Newcastle,
Australia. The expenses for ActiGraph devices and software are supported by
an infrastructure grant, Priority Research Centre for Brain and Mental Health,
The University of Newcastle, Australia.
Authors’contributions
All the authors (NTTH, GB, LM, VA, and SWCC) contributed to the conception
and design of the research. NTTH will contribute to the conduct of the study
and acquisition of the data, data analysis, and interpretation of the findings.
SWCC, GB, LM, and VA will provide guidance and support in conducting
research, data analysis and interpretation of the findings. NTTH wrote the
first draft of the manuscript. All authors (NTTH, GB, LM, VA, and SWCC)
critically reviewed, revised, and approved the final version of the manuscript.
Availability of data and materials
The study findings will be published in journals and presented at local and
international conferences. The datasets analysed during this study will be
available from the corresponding author upon reasonable request.
Ethics approval and consent to participate
This study will be conducted with approval from the local university human
research ethics committee, granted in February 2019 (approval reference no.
H-2018-0345). Study participants will be given detailed information about the
study purpose and procedures before they are asked to provide consent to
participate. Participants who agree to participate will be required to sign a
written consent form before being enrolled in the study.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no completing interests.
Author details
1
School of Nursing and Midwifery, The University of Newcastle, University
Drive, Callaghan, NSW 2308, Australia.
2
Maroba Caring Communities,
Hmwe et al. Trials (2020) 21:360 Page 9 of 10
Content courtesy of Springer Nature, terms of use apply. Rights reserved.

Waratah, NSW, Australia.
3
UON Singapore, International and Advancement
Division, The University of Newcastle, Callaghan, NSW, Australia.
Received: 2 December 2019 Accepted: 26 March 2020
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