- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07349446
Effects of Circadian-Based Acupressure on Sleep Quality in Nursing Home Residents
January 15, 2026 updated by: Santa Maria Pangaribuan, Taipei Medical University
Effects of Circadian-Based Acupressure on Sleep Quality in Nursing Home Residents: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of circadian-based acupressure compared with sham acupressure in improving sleep quality among nursing home residents.
Additionally, the study will examine the effects of the intervention on insomnia severity, heart rate variability, and psychological distress, including depression, anxiety, and stress.
A total of 80 older adults aged 60 years and above residing in a nursing home in Jakarta, Indonesia, will be randomly assigned to either the circadian-based acupressure group or the sham acupressure group.
Participants in the intervention group will receive circadian-based acupressure twice daily, five days per week for four weeks, with acupoints selected and administered according to circadian meridian activity, while the control group will receive sham acupressure at non-acupuncture points with the same frequency and duration.
Outcome measures will be assessed at baseline and immediately post-intervention.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Poor sleep quality affects approximately 65% of institutionalized older adults and is associated with adverse outcomes including cognitive decline, psychological distress, falls, and increased mortality.
Current geriatric guidelines recommend nonpharmacological interventions as first-line management for sleep disturbances.
Acupressure, a low-cost and non-invasive therapy derived from Traditional Chinese Medicine (TCM), has shown promise in improving sleep; however, prior trials have largely used fixed protocols without considering circadian timing.
According to TCM meridian clock theory, qi circulates through specific meridians in a 24-hour rhythm, suggesting that time-aligned acupressure may enhance therapeutic effects.
To evaluate the effectiveness of circadian-based acupressure on sleep quality in nursing home residents compared with sham acupressure, and to examine its effects on insomnia severity, heart rate variability (HRV), depression, anxiety, and stress.
This randomized, participant- and assessor-blinded controlled trial will recruit 80 nursing home residents aged ≥60 years in Jakarta, Indonesia.
Eligible participants must have lived in the facility for ≥3 months, score ≥25 on the Mini-Mental State Examination, and have poor sleep quality (PSQI ≥5).
Participants will be randomly assigned (1:1) to circadian-based acupressure or sham acupressure.
The intervention will be delivered twice daily, five days per week for four weeks: SP6 and HT7 at 11:00 am, and PC6 and GB20 at 7:00 pm, aligning with circadian meridian activity.
Each acupoint will be stimulated for 3 minutes using standardized pressure.
The sham group will receive massage at non-acupoints with identical frequency and duration.
The primary outcome is sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI).
Secondary outcomes include insomnia severity (Athens Insomnia Scale), HRV (ANSWatch), and psychological distress (DASS-21).
Measurements will be collected at baseline and immediately post-intervention (Week 4).
Analyses will follow the intention-to-treat principle.
Baseline differences will be assessed using chi-square tests, ANOVA, or nonparametric equivalents.
Intervention effects over time will be examined using generalized estimating equations to assess group × time interactions, adjusting for demographic covariates.
Post-hoc pairwise comparisons will be conducted when appropriate.
Missing data will be handled using multiple imputation.
Statistical significance will be set at p ≤ 0.05.
This study is the first randomized controlled trial to investigate circadian-based acupressure in nursing home residents.
Findings will provide evidence on whether aligning acupressure with circadian meridian activity enhances sleep quality and related physiological and psychological outcomes, supporting a feasible and theory-driven nonpharmacological intervention for institutionalized older adults.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: SANTA MARIA PANGARIBUAN, M.Sc
- Phone Number: 0000 +6285132499047
- Email: maria.pangaribuan@ukrida.ac.id
Study Contact Backup
- Name: Hsiao Yean Chiu, PhD
- Phone Number: 6301 / 6329 +886-2-27361661
- Email: hychiu0315@tmu.edu.tw
Study Locations
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesia, 12840
- Jl. Bina Marga No.58 7 6 7, RT.7/RW.5, Cipayung, Kec. Cipayung, Kota Jakarta Timur, Daerah Khusus Ibukota Jakarta 13840
-
Contact:
- Panti Werdha Budi Mulia I Cipayung
- Phone Number: (021) 87713052
- Email: pstwbm1ciracas1@gmail.com
-
Contact:
- Rahmat Prastyan, Registered Nurse
- Phone Number: +628567305855
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age ≥60 years
- ability to communicate and complete the questionnaires in Indonesian
- had lived in the nursing home for at least 3 months,
- had a Mini-Mental State Examination score of ≥25, had self-reported PSQI Indonesian version scores of ≥5 (where higher scores indicate worse sleep) over the past 4 weeks,
- agreed to participate in the research
Exclusion Criteria:
- The exclusion criteria in this study were severe psychiatric disorders, such as schizophrenia, bipolar disorder, or current receipt of intensive psychiatric treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Circadian-based acupressure
Participants in the Circadian-based Acupressure group will receive circadian-based acupressure twice daily, five days a week for four weeks.
|
Participants in the Circadian-based Acupressure group will receive circadian-based acupressure twice daily, five days a week for four weeks.
Acupressure will be administered in the morning one hour after breakfast (at 11am) and in the evening one to two hours before bedtime (at 7 pm).
Acupressure was performed by applying consistent fingertip pressure of 3-5 kg, with gentle rotational movements, on the selected acupoints.
The selected acupoints were based on our network meta-analysis the most used acupoint: Sanyinjiao (SP6), Shenmen (HT7), Fengchi (GB20), and Neiguan (PC6).
The accuracy of the acupressure was confirmed if the participants felt sore, numb, distended, or warm at the point of application.
The duration of each session was limited to 3 minutes, with an interval of 5 seconds of pressure followed by a 1-second rest.
Acupoints of Sanyinjiao and Shenmen will be apply at 11 am and Neiguan and Fengchi at 7 pm.
|
|
Sham Comparator: Sham Acupressure
Sham Acupressure (placebo) group received massage at a non-acupuncture point.
|
Sham Acupressure (placebo) group received massage at a non-acupuncture point, located 10 mm from the actual point, with the same frequency as the experimental group.
According to traditional Chinese medicine, manipulation of non-acupuncture points should not elicit a sensation of de qi.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep quality
Time Frame: Baseline (before intervention/0 weeks) and After Intervention (4 weeks)
|
Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI).
The PSQI can be used to assess self- reported sleep quality and sleep disturbance in the preceding month.
The scale comprises 19 items and the following seven dimensions: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) sleep efficiency, (5) sleep disturbance, (6) sleeping medication use, and (7) daytime dysfunction.
The items are rated on a four-point Likert scale with endpoints ranging from 0 to 3, and the overall score ranges from 0 to 20.
A score of less than five indicates favorable sleep quality.
The Indonesian version of the PSQI exhibited high validity and reliability (Cronbach's α = 0.720)
|
Baseline (before intervention/0 weeks) and After Intervention (4 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Variability
Time Frame: Baseline (before intervention/0 weeks) and After Intervention (4 weeks)
|
HRV was measured using a wrist monitor ANSWatch model (TS-0411, Taiwan Scientific Corp., Taipei, Taiwan).
ANSWatch was calibrated using a sphygmomanometer U-300 with an accuracy of ±8 mmHg, and calibrated using ECG (Agilent A3) with an accuracy of ±5%
|
Baseline (before intervention/0 weeks) and After Intervention (4 weeks)
|
|
Insomnia
Time Frame: Baseline (before intervention/0 weeks) and After Intervention (4 weeks)
|
Insomnia was measured using Athens Insomnia Scale.
The AIS-8 is an eight-item self-report questionnaire that measures the intensity of sleep difficulties (Soldatos et al., 2000, 2003) in accordance with the ICD-10 diagnostic criteria for insomnia.
Five items assess sleep induction, awakenings during the night, final awakening earlier than desired, total sleep duration, and overall sleep quality.
Total scores for the AIS-8 range from 0 to 24.
The AIS Indonesian demonstrated favorable internal consistency (Cronbach's α: 0.86), and acceptable test-retest reliability (0.85).
CFA indicated a strong model fit for the AIS-I.
AIS-I scores exhibited significant associations with the ISCI, IGAD-7, and IPHQ-9, and EQ-5D (r = -0.55,
0.55, 0.66, and -0.31, respectively, all P < .001).
Scores greater than 7 were classified as indicating insomnia.
|
Baseline (before intervention/0 weeks) and After Intervention (4 weeks)
|
|
Psychological distress
Time Frame: Baseline (before intervention/0 weeks) and After Intervention (4 weeks)
|
Psychological distress was measured using the Depression, Anxiety and Stress Scale (DASS-21) Bahasa Indonesia version.
It is translated by Damanik (2011).
This is a self-report questionnaire consists of three 14-items subscales, measure depression, anxiety and stress (negative mental health).
Total score ranged from 0-42 with higher scores showing higher level of distress.
|
Baseline (before intervention/0 weeks) and After Intervention (4 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Santa Maria Pangaribuan, M.Sc, Taipei Medical University, Taiwan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Soldatos CR, Dikeos DG, Paparrigopoulos TJ. The diagnostic validity of the Athens Insomnia Scale. J Psychosom Res. 2003 Sep;55(3):263-7. doi: 10.1016/s0022-3999(02)00604-9.
- Soldatos CR, Dikeos DG, Paparrigopoulos TJ. Athens Insomnia Scale: validation of an instrument based on ICD-10 criteria. J Psychosom Res. 2000 Jun;48(6):555-60. doi: 10.1016/s0022-3999(00)00095-7.
- Schlaeger JM, Gabzdyl EM, Bussell JL, Takakura N, Yajima H, Takayama M, Wilkie DJ. Acupuncture and Acupressure in Labor. J Midwifery Womens Health. 2017 Jan;62(1):12-28. doi: 10.1111/jmwh.12545. Epub 2016 Dec 21.
- Setyowati A, Chung MH. Validity and reliability of the Indonesian version of the Pittsburgh Sleep Quality Index in adolescents. Int J Nurs Pract. 2021 Oct;27(5):e12856. doi: 10.1111/ijn.12856. Epub 2020 Jul 7.
- Reza H, Kian N, Pouresmail Z, Masood K, Sadat Seyed Bagher M, Cheraghi MA. The effect of acupressure on quality of sleep in Iranian elderly nursing home residents. Complement Ther Clin Pract. 2010 May;16(2):81-5. doi: 10.1016/j.ctcp.2009.07.003. Epub 2009 Aug 19.
- Raana HN, Fan XN. The effect of acupressure on pain reduction during first stage of labour: A systematic review and meta-analysis. Complement Ther Clin Pract. 2020 May;39:101126. doi: 10.1016/j.ctcp.2020.101126. Epub 2020 Feb 29.
- Geng SH, Liu L, Lin ZM, Zhang H, Mei RG, Liu X, Liu JC, Huang GR, Zhang WC. A review of novel research technology to explore the mystery of traditional Chinese medicine: Terahertz. Medicine (Baltimore). 2023 Nov 17;102(46):e35870. doi: 10.1097/MD.0000000000035870.
- Pangaribuan SM, Wu TY, Herlianita R, Jao YL, Lee HC, Hasan F, Mukminin MA, Chiu HY. Global occurrence rates of sleep disturbances among institutionalized older adults: A systematic review and meta-analysis. Sleep Med Rev. 2025 Jun;81:102091. doi: 10.1016/j.smrv.2025.102091. Epub 2025 Apr 11.
- Luo J, Feng L, Wang L, Fang Z, Lang J, Lang B. Restoring brain health: Electroacupuncture at GB20 and LR3 for migraine mitigation through mitochondrial restoration. Brain Circ. 2024 Jun 26;10(2):154-161. doi: 10.4103/bc.bc_95_23. eCollection 2024 Apr-Jun.
- Li LW, Harris RE, Tsodikov A, Struble L, Murphy SL. Self-Acupressure for Older Adults With Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Feb;70(2):221-229. doi: 10.1002/acr.23262. Epub 2017 Dec 29.
- Lee WJ, Park H. Effects of auricular acupressure on sleep and pain in elderly people who have osteoarthritis and live in nursing homes: A randomized, single-blind, placebo-controlled trial. Explore (NY). 2023 Mar-Apr;19(2):214-222. doi: 10.1016/j.explore.2022.07.001. Epub 2022 Jul 5.
- Lee IS, Ryu Y, Chae Y. Oversimplifying the name of the 12 meridian channels. Integr Med Res. 2023 Dec;12(4):101002. doi: 10.1016/j.imr.2023.101002. Epub 2023 Oct 21. No abstract available.
- Lai FC, Chen IH, Chen PJ, Chen IJ, Chien HW, Yuan CF. Acupressure, Sleep, and Quality of Life in Institutionalized Older Adults: A Randomized Controlled Trial. J Am Geriatr Soc. 2017 May;65(5):e103-e108. doi: 10.1111/jgs.14729. Epub 2017 Feb 2.
- Hmwe NT, Subramanian P, Tan LP, Chong WK. The effects of acupressure on depression, anxiety and stress in patients with hemodialysis: a randomized controlled trial. Int J Nurs Stud. 2015 Feb;52(2):509-18. doi: 10.1016/j.ijnurstu.2014.11.002. Epub 2014 Nov 11.
- Hmwe NTT, Browne G, Mollart L, Allanson V, Chan SW. Acupressure to improve sleep quality of older people in residential aged care: a randomised controlled trial protocol. Trials. 2020 Apr 25;21(1):360. doi: 10.1186/s13063-020-04286-2.
- Bourgeois J, Elseviers MM, Van Bortel L, Petrovic M, Vander Stichele RH. Sleep quality of benzodiazepine users in nursing homes: a comparative study with nonusers. Sleep Med. 2013 Jul;14(7):614-21. doi: 10.1016/j.sleep.2013.03.012. Epub 2013 May 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 20, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
January 9, 2026
First Submitted That Met QC Criteria
January 9, 2026
First Posted (Estimated)
January 16, 2026
Study Record Updates
Last Update Posted (Actual)
January 20, 2026
Last Update Submitted That Met QC Criteria
January 15, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001/KEPK/IKI/E2/I/2026
- NSTC113-2628-B-038-003-MY3 (Other Grant/Funding Number: Taiwan's National Science and Technology Council)
- NSTC114-2314-B-038-094-MY3 (Other Grant/Funding Number: Taiwan's National Science and Technology Council)
- 01/UKKW/LPPM-FKIK/LIT/I/2026 (Other Grant/Funding Number: Universitas Kristen Krida Wacana)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Particular data will be shared: Individual participant data that underlie the results reported in this article after identification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 60 months following article publication.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose, for example, for a meta-analysis or other study.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States
Clinical Trials on Circadian-based acupressure
-
China Medical University HospitalNational Science and Technology CouncilRecruitingIschemic Stroke | Sleep | Circadian Rhythm | Post-stroke Fatigue | Acupressure | Inflammatory CytokineTaiwan
-
Oregon Health and Science UniversityRecruitingWeight Loss | Circadian Rhythm | Time Restricted Feeding | Cardiometabolic Health | Cardiovascular HealthUnited States
-
Taipei Medical UniversityNot yet recruitingFatigue | Hemodialysis PatientVietnam
-
Ove AndersenAalborg University; Albertslund Kommune; Gate 21; Chromaviso A/SCompletedElderly Housing Residents With Frailty or DementiaDenmark
-
Assaf-Harofeh Medical CenterHadassah Medical Organization; Western University, CanadaNot yet recruitingADHD | Memory Impairment | T1DM | Sleep Disorders, Circadian Rhythm
-
University of UtahRecruitingSleep | Type 2 Diabetes | Overweight and Obesity | Insulin Sensitivity | Time Restricted Feeding | Sleep Hygiene | Cardiometabolic Syndrome | Eating Habit | Lifestyle FactorsUnited States
-
Chang-Hua HospitalChina Medical University HospitalUnknownInsomnia | Anxiety | Menopause | Auricular AcupressureTaiwan
-
University of AarhusRecruitingCircadian Rhythm | Time PerceptionDenmark
-
University of ChicagoCompleted
-
Mersin UniversityRecruiting