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Poor Sleep QualityNCT07349446

Effects of Circadian-Based Acupressure on Sleep Quality in Nursing Home Residents

A study testing Circadian-based acupressure in people with Poor Sleep Quality and Anxiety, run by Taipei Medical University at 1 site in Indonesia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Poor Sleep Quality, Anxiety, Depression
What is being tested?
Circadian-based acupressure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteIndonesia
Study dates
20 Jan 2026to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • The exclusion criteria in this study were severe psychiatric disorders, such as schizophrenia, bipolar disorder, or current receipt of intensive psychiatric treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Indonesia1 site
  • Jl. Bina Marga No.58 7 6 7, RT.7/RW.5, Cipayung, Kec. Cipayung, Kota Jakarta Timur, Daerah Khusus Ibukota Jakarta 13840

    Jakarta, DKI Jakarta, 12840

    Panti Werdha Budi Mulia I Cipayung, (021) 87713052, pstwbm1ciracas1@gmail.com

    Rahmat Prastyan, Registered Nurse, +628567305855

Other trials in Indonesia

About this study

Official title: 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.

Read the 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.

Being tested
Circadian-based acupressure, Sham Acupressure
Keywords
poor sleep quality, Insomnia, depression, anxiety, stress
Medical subject headings
Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Circadian-based acupressureOther

    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 AcupressureOther

    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.

Study groups in NCT07349446
Study groupRoleWhat they receive
Circadian-based acupressureExperimentalParticipants in the Circadian-based Acupressure group will receive circadian-based acupressure twice daily, five days a week for four weeks.
Receives: Other: Circadian-based acupressure
Sham AcupressureSham comparatorSham Acupressure (placebo) group received massage at a non-acupuncture point.
Receives: Other: Sham Acupressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep quality

    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)

    Measured: Baseline (before intervention/0 weeks) and After Intervention (4 weeks)

Secondary outcomes (3)
  1. Insomnia

    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.

    Measured: Baseline (before intervention/0 weeks) and After Intervention (4 weeks)

  2. Heart Rate Variability

    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%

    Measured: Baseline (before intervention/0 weeks) and After Intervention (4 weeks)

  3. Psychological distress

    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.

    Measured: Baseline (before intervention/0 weeks) and After Intervention (4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study start20 Jan 2026 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two arm parallel group designs: (1) Circadian-based acupressure intervention, and (2) Sham acupressure.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07349446
Sponsor's protocol ID
001/KEPK/IKI/E2/I/2026
Other IDs
NSTC113-2628-B-038-003-MY3, NSTC114-2314-B-038-094-MY3, 01/UKKW/LPPM-FKIK/LIT/I/2026
Status last verified
Jan 2026
First submitted
9 Jan 2026
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Particular data will be shared: Individual participant data that underlie the results reported in this article after identification (text, tables, figures, and appendices).

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.

    PubMed 12932801
  • 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.

    PubMed 11033374
  • 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.

    PubMed 32632973
  • 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.

    PubMed 28002621
  • 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.

    PubMed 20347838
  • 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.

    PubMed 32379664
  • 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.

    PubMed 37986326
  • 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.

    PubMed 40239318
  • 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.

    PubMed 39036293
  • 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.

    PubMed 28437570
  • 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.

    PubMed 35835645
  • 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.

    PubMed 37953755
  • 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.

    PubMed 28152177
  • 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.

    PubMed 25468282
  • 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.

    PubMed 32334620

Questions about this trial

What is this clinical trial studying?

A study testing Circadian-based acupressure in people with Poor Sleep Quality and Anxiety, run by Taipei Medical University at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SANTA MARIA PANGARIBUAN, M.Sc (+6285132499047 ext. 0000, maria.pangaribuan@ukrida.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep quality (time frame: Baseline (before intervention/0 weeks) and After Intervention (4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07349446, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

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