NCT07349446

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

January 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 9, 2026

Last Update Submit

January 15, 2026

Conditions

Keywords

poor sleep qualityInsomniadepressionanxietystress

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (3)

  • Insomnia

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

  • Heart Rate Variability

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

  • Psychological distress

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

Study Arms (2)

Circadian-based acupressure

EXPERIMENTAL

Participants in the Circadian-based Acupressure group will receive circadian-based acupressure twice daily, five days a week for four weeks.

Other: Circadian-based acupressure

Sham Acupressure

SHAM COMPARATOR

Sham Acupressure (placebo) group received massage at a non-acupuncture point.

Other: Sham Acupressure

Interventions

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.

Circadian-based acupressure

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.

Sham Acupressure

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, Indonesia

Location

Related Publications (16)

  • 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.

    PMID: 12932801BACKGROUND
  • 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.

    PMID: 11033374BACKGROUND
  • 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.

    PMID: 32632973BACKGROUND
  • 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.

    PMID: 28002621BACKGROUND
  • 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.

    PMID: 20347838BACKGROUND
  • 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.

    PMID: 32379664BACKGROUND
  • 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.

    PMID: 37986326BACKGROUND
  • 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.

    PMID: 40239318BACKGROUND
  • 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.

    PMID: 39036293BACKGROUND
  • 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.

    PMID: 28437570BACKGROUND
  • 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.

    PMID: 35835645BACKGROUND
  • 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.

    PMID: 37953755BACKGROUND
  • 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.

    PMID: 28152177BACKGROUND
  • 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.

    PMID: 25468282BACKGROUND
  • 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.

    PMID: 32334620BACKGROUND
  • 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.

    PMID: 23692988BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepressionSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Santa Maria Pangaribuan, M.Sc

    Taipei Medical University, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SANTA MARIA PANGARIBUAN, M.Sc

CONTACT

Hsiao Yean Chiu, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participant will be blinded to group allocation. Outcome assessors will remain blinded to group allocation until the end of the study, therapists will be aware of group assignments due to the nature of the intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two arm parallel group designs: (1) Circadian-based acupressure intervention, and (2) Sham acupressure.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Registered Nurse

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 16, 2026

Study Start

January 20, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Particular data will be shared: Individual participant data that underlie the results reported in this article after identification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending 60 months following article publication.
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.

Locations