Effects of Circadian-Based Acupressure on Sleep Quality in Nursing Home Residents
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorTaipei Medical University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
The exclusion criteria in this study were severe psychiatric disorders, such as schizophrenia, bipolar disorder, or current receipt of intensive psychiatric treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
Circadian-based acupressure
Other interventionParticipants 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
Other interventionSham 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Circadian-based acupressureExperimental treatment 1 intervention
Group B: Sham AcupressureSham comparator 1 intervention
Trial outcomes
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)
Time frame
Baseline (before intervention/0 weeks) and After Intervention (4 weeks)Secondary outcomes
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.
Time frame
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%
Time frame
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.
Time frame
Baseline (before intervention/0 weeks) and After Intervention (4 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Taipei Medical University
Lead sponsor
Krida Wacana Christian University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: