Anxiety, Depression, Insomnia, Poor Sleep Quality, Stress
Conditions
Keywords
poor sleep quality, Insomnia, depression, anxiety, stress
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.
Interventions
OTHERCircadian-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.
OTHERSham 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.
Sponsors
Taipei Medical University
Krida Wacana Christian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Two arm parallel group designs: (1) Circadian-based acupressure intervention, and (2) Sham acupressure.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia | 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. |
| Heart Rate Variability | 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% |
| Psychological distress | 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. |
Countries
Indonesia
Contacts
CONTACTSANTA MARIA PANGARIBUAN, M.Sc
CONTACTHsiao Yean Chiu, PhD
PRINCIPAL_INVESTIGATORSanta Maria Pangaribuan, M.Sc
Taipei Medical University, Taiwan
Outcome results
None listed