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Trial registered on ANZCTR


Registration number
ACTRN12619000262101
Ethics application status
Approved
Date submitted
14/02/2019
Date registered
20/02/2019
Date last updated
30/01/2020
Date data sharing statement initially provided
20/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupressure to Promote Sleep Quality of Older People in Residential Aged Care Facilities
Scientific title
Acupressure to Promote Sleep Quality of Older People in Residential Aged Care Facilities
Secondary ID [1] 297373 0
None
Universal Trial Number (UTN)
U1111-1228-3908
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep disturbance 311512 0
poor sleep quality 311632 0
Condition category
Condition code
Alternative and Complementary Medicine 310148 310148 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves 12-minute acupressure sessions, three times a week for four weeks. Acupressure technique is application of finger or thumb pressure for 2 minutes on each acupoint (acupuncture point) using circular motion. The selected acupoints are HT7, PC6 and SP6; located on both wrists, hands, and calves. The time for acupressure will be scheduled in the morning or afternoon (from 9am – 5pm), at a convenient time for the participants.

Acupressure will be performed by the PhD student researcher, who has career background in general nursing, hemodialysis and nursing education. She attended acupressure practitioner training in Sydney, Australia. One of the supervisors of the PhD student researcher is a qualified acupressure practitioner. She has supervised the design and implementation of the acupressure intervention.

This dosage is based on the findings of systematic and integrative reviews (Hmwe et al., 2018; Hmwe et al., 2016; Waits et al., 2016). For the present study, acupressure intervention protocol has been developed based on TCM concepts, literatures including reviews (Hmwe et al., 2016; Hmwe et al.; 2018; Huang et al., 2009; Waits et al., 2016), research evidences (Lai et al., 2017; Lu et al., 2013; Reza et al., 2010; Zeng et al., 2016), and consultation with qualified specialist in acupressure (one of the PhD supervisors).

To maintain fidelity of the intervention, student researcher will adhere to the acupressure intervention protocol. She will keep field note records, which include date and time of acupressure sessions, and observation on participants' general condition during each acupressure session. The supervision team will monitor the performance of student researcher.
Intervention code [1] 313629 0
Treatment: Other
Comparator / control treatment
Control treatment is the routine care offered in the residential aged care facility.
Control group will receive routine daily care, general healthcare and personalized care based on their individual needs and medical condition. The nature of care provided to control group will be the same as that given to intervention group, except for the acupressure.
Control group
Active

Outcomes
Primary outcome [1] 319046 0
The primary outcome is sleep quality, measured using the Pittsburgh Sleep Quality Index- PSQI (Buysse et al., 1989).
Timepoint [1] 319046 0
The PSQI questionnaire will be administered before commencing the intervention (pre-test), at the finish of intervention (post-test), and 2-week post intervention.

Primary outcome [2] 319129 0
Objective sleep measurement, using Actigraph.

The actigraph is an ambulatory device used to measure objective sleep pattern, based on the periods of activity and inactivity of a person. It is equipped with a sensor, and worn by participants to record gross motor activities continuously over extended period of time. A minimum of 1-week period is required to achieve the reliable estimate of sleep patterns. The recorded data will be downloaded for analysis, using actigraph software (ActiLife 6).
Timepoint [2] 319129 0
Actigraph record will be obtained for one week period before the intervention, after the intervention, and 2-week post-intervention.
Participants will be instructed to wear the actigraph on the dominant wrist for seven consecutive days and night, and to be removed only when they are showering.
Primary outcome [3] 319144 0
Feasibility of the acupressure intervention will be measured by the following parameters:
(This is a composite outcome for feasibility.)
- Recruitment rate: number and percent of residents recruited from selected aged care center.
- Adherence to intervention protocol: number and percent of participants who completed acupressure sessions; three times per week for four weeks, a total of 12 sessions.
- Completion rate: number and percent of participants who completed outcome assessments.

Timepoint [3] 319144 0
Recruitment rate will be measured during recruitment process, before intervention.

Adherence to intervention protocol will be measured at the end of 4-week acupressure intervention.

Completion rate will be measured after administration of questionnaires for post-test, and 2-week post intervention.
Secondary outcome [1] 366789 0
Depression and anxiety, measured using the Hospital Anxiety and Depression Scale- HADS (Zigmond and Snaith, 1983).
Timepoint [1] 366789 0
before commencing intervention (pre-test), at the finish of intervention (post-test), and 2-week post intervention.
Secondary outcome [2] 366790 0
Quality of life, measured using the brief Older People’s Quality of Life questionnaire (Bowling et al., 2013)
Timepoint [2] 366790 0
before commencing intervention (pre-test), at the finish of intervention (post-test), and 2-week post intervention.

Eligibility
Key inclusion criteria
i) aged 65 and above,
ii) a resident of an aged care facility or a retirement village
iii) self-reported poor sleep quality,
iv) able to communicate with researcher in response to questionnaires, and
v) give informed valid consent to participate in the study
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) severe cognitive impairment (MMSE score 9 or less),
ii) amputation of upper or lower limbs because acupressure will be applied on both hands and legs,
iii) recent fracture on forearm or on the leg,
iv) severe illness, presence of bleeding disorder such as haemophilia, or blood clotting disorders such as thrombophlebitis to avoid potential complications,
v) current treatment on blood thinning drugs, and
vi) inflammation, skin infection or lesions near selected acupoints.

Level of cognitive impairment will be identified based on Mini-Mental Health Status (MMSE) record in the respective care unit. The MMSE score less than or equal to 9, will be considered as severe cognitive impairment in older population (Molloy et al., 1991; Molloy and Standish, 1997).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered sealed envelopes will be used for allocation concealment,
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization with 1:1 allocation ratio and block size of four will be applied.
The randomization scheme will be generated by using the online tool on sealedenvelope.com (https://www.sealedenvelope.com/simple-randomiser/v1/lists).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The generalised estimation equation (GEE) for repeated measurements will be used to examine the intervention effects on sleep quality, depression, anxiety, and QoL. Adjusted analyses will be conducted for age group, gender, use of sleep medication, and baseline PSQI, HADS and QoL scores. Sub-group analyses will be conducted to determine the differences in treatment effect of acupressure based on age groups, and use of sleep medication (yes/no).
The intention-to-treat method will be used. Missing-at-random assumption will be used to handle missing data in GEE analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301941 0
University
Name [1] 301941 0
The University of Newcastle, Australia
Address [1] 301941 0
University Drive, Callaghan NSW 2308 Australia
Country [1] 301941 0
Australia
Primary sponsor type
University
Name
The University of Newcastle, Australia
Address
University Drive, Callaghan NSW 2308 Australia
Country
Australia
Secondary sponsor category [1] 301704 0
None
Name [1] 301704 0
Address [1] 301704 0
Country [1] 301704 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302623 0
The University of Newcastle, Human Research Ethic Committee
Ethics committee address [1] 302623 0
Human Research Ethics Administration
Research & Innovation Services
Research Integrity Unit
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 302623 0
Australia
Date submitted for ethics approval [1] 302623 0
23/08/2018
Approval date [1] 302623 0
11/02/2019
Ethics approval number [1] 302623 0
H-2018-0345

Summary
Brief summary
This aim of this study is to evaluate the feasibility and effects of acupressure intervention to improve on sleep quality of older persons living in residential care, within Australian context. Study participants will be older persons receiving services from aged care facilities and retirement village. They will be randomly assigned into intervention and control groups. The intervention group will receive acupressure (12-minute/session) three time a week for four weeks. Control group will receive routine care only. The primary outcome measures include sleep quality and feasibility of acupressure intervention (recruitment, adherence and completion rate). The secondary outcomes are depression, anxiety and quality of life. The baseline data will be collected before commencing acupressure intervention (T0), followed by 4-week acupressure sessions. The outcome data will be collected at the end of intervention (T1) and two weeks after the intervention (T2).
Trial website
Trial related presentations / publications
Public notes
This study is supported by research scholarship awarded to the first author (a PhD Candidate), from The University of Newcastle International Postgraduate Research Scholarship (2017 UNIPRS) and The University of Newcastle Research Scholarship Central (2017 UNRSC). The study was also supported by Research Training Program Funding from School of Nursing and Midwifery, The University of Newcastle. Expenses for actigraph software and devices are supported by the Infrastructure Grant, Priority Research Centre for Brain and Mental Health.

Contacts
Principal investigator
Name 90854 0
Prof Sally Wai-Chi Chan
Address 90854 0
School of Nursing and Midwifery
Faculty of Health and Medicine
The University of Newcastle
University Drive, Callaghan NSW 2308 Australia
Country 90854 0
Australia
Phone 90854 0
+61 2 4921 6770
Fax 90854 0
+61 2 4921 6981
Email 90854 0
sally.chan@newcastle.edu.au
Contact person for public queries
Name 90855 0
Prof Sally Wai-Chi Chan
Address 90855 0
School of Nursing and Midwifery
Faculty of Health and Medicine
The University of Newcastle
University Drive, Callaghan NSW 2308 Australia
Country 90855 0
Australia
Phone 90855 0
+61 2 4921 6770
Fax 90855 0
+61 2 4921 6981
Email 90855 0
sally.chan@newcastle.edu.au
Contact person for scientific queries
Name 90856 0
Prof Sally Wai-Chi Chan
Address 90856 0
School of Nursing and Midwifery
Faculty of Health and Medicine
The University of Newcastle
University Drive, Callaghan NSW 2308 Australia
Country 90856 0
Australia
Phone 90856 0
+61 2 4921 6770
Fax 90856 0
+61 2 4921 6981
Email 90856 0
sally.chan@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification; individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, and no end date
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
For secondary analysis or meta-analysis.
How or where can data be obtained?
access subject to approvals by Principal Investigator
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 1345 0
Study protocol
Citation [1] 1345 0
Link [1] 1345 0
Email [1] 1345 0
Other [1] 1345 0
The study protocol will be submitted for publication in a Journal..
The URL will be given when it is published.
Attachment [1] 1345 0
Summary results
No Results