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

NCT ID: NCT07349446

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-20
• Study Completion Date: 2026-06-30

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.

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.

Conditions

Poor Sleep Quality; Anxiety; Depression; Stress; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Circadian-based acupressure

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

Group Type: EXPERIMENTAL

Circadian-based acupressure

Intervention Type: OTHER

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 Acupressure

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

Group Type: SHAM_COMPARATOR

Sham Acupressure

Intervention Type: OTHER

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.

Interventions

Circadian-based acupressure

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.

Intervention Type: OTHER

Sham 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Krida Wacana Christian University

OTHER

Sponsor Role: collaborator

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Santa Maria Pangaribuan

Principal Investigator, Registered Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Santa Maria Pangaribuan, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University, Taiwan

Locations

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, Indonesia

Countries

Indonesia

Central Contacts

SANTA MARIA PANGARIBUAN, M.Sc

Role: CONTACT

maria.pangaribuan@ukrida.ac.id

+6285132499047 ext. 0000

Hsiao Yean Chiu, PhD

Role: CONTACT

hychiu0315@tmu.edu.tw

+886-2-27361661 ext. 6301 / 6329

Facility Contacts

Panti Werdha Budi Mulia I Cipayung

Role: primary

pstwbm1ciracas1@gmail.com

(021) 87713052

Rahmat Prastyan, Registered Nurse

Role: backup

+628567305855

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Other Identifiers

NSTC113-2628-B-038-003-MY3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NSTC114-2314-B-038-094-MY3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

01/UKKW/LPPM-FKIK/LIT/I/2026

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

001/KEPK/IKI/E2/I/2026

Identifier Type: -

Identifier Source: org_study_id