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临床试验/NCT07349446
NCT07349446尚未招募不适用

Effects of Circadian-Based Acupressure on Sleep Quality in Nursing Home Residents: A Randomized Controlled Trial

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Sleep quality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Circadian-based acupressure (Other)

Sham Acupressure

Sham Comparator

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

干预措施: Sham Acupressure (Other)

结局指标

主要结局

Sleep quality

时间窗: 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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Santa Maria Pangaribuan

Principal Investigator, Registered Nurse

Taipei Medical University

研究点 (1)

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