Self-acupressure for Insomnia in Perimenopausal Women
- Conditions
- InsomniaPerimenopausal Women
- Interventions
- Behavioral: Self-Administered Acupressure GroupBehavioral: Sleep Hygiene Education group
- Registration Number
- NCT06463197
- Lead Sponsor
- The Hong Kong Polytechnic University
- Brief Summary
Insomnia is a common complaint in peri-menopausal women. Acupressure might be a potential way to treat insomnia. Although acupressure can be self-administered, it is uncertain that whether the effects of self-administered acupressure are comparable to that of the practitioner-administered acupressure, due to the variability in patients' capability of mastering the acupressure technique and self-compliance. Previous studies seemingly suggested that self-administered acupressure may improve sleep quality, their conclusion on the efficacy of self-administered acupressure for insomnia was limited due to the lack of standardized subjective and objective sleep assessments and unclear diagnostic method of insomnia. To fill out this research gap, the proposed study will explore the effectiveness of self-acupressure for improving sleep in perimenopasual women using an RCT approach.
- Detailed Description
Insomnia is a common complaint in peri-menopausal women, with approximately one-third to half of the women aged 40-55 years suffering from insomnia. A recent clinical study indicated that the microbial composition in insomnia patients was different from healthy controls, and the immune factors and metabolic pathways could mediate the relationship between gut microbes and insomnia. However, such linkage needs more studies to verify.
Acupressure is a treatment modality in traditional Chinese medicine (TCM), in which the practitioner stimulates patient's acupoints using fingers, hands, or elbows according to TCM meridian theory.
Instead of practitioner-administered, the patients can be trained and perform acupressure on themselves. Such self-administered acupressure is less time-intensive and flexible to perform. Once the patient has learned the technique, self-administered acupressure does not cost anything, hence constitutes the lowest financial burden.
Although acupressure can be self-administered, it is uncertain that whether the effects of self-administered acupressure are comparable to that of the practitioner-administered acupressure, due to the variability in patients' capability of mastering the acupressure technique and self-compliance. Previous studies seemingly suggested that self-administered acupressure may improve sleep quality, their conclusion on the efficacy of self-administered acupressure for insomnia was limited due to the lack of standardized subjective and objective sleep assessments and unclear diagnostic method of insomnia. To fill out this research gap, the proposed study will explore the effectiveness of self-acupressure for improving sleep in perimenopasual women using an RCT approach.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Self-acupressure group Self-Administered Acupressure Group Subjects will attend two weekly 120-minute of self-administered acupressure training according to the group allocation in a classroom at the School Nursing, the Hong Kong Polytechnic University. The subjects will be trained to perform self-administered acupressure by an acupuncturist. To enhance interaction and ensure the quality of teaching, each class will be conducted in a small group of 5 to 7 subjects. Participants in this group will learn the self-acupressure technique and passed fidelity check. The treatment protocol included 6 acupoints, namely, Baihui (GV20) and bilateral Fenchi (GB20), Neiguan (PC6), Shenmen (HT7), Shenxu (BL23) and Yongquan (KI1) (Table 1). Subjects were given an acupressure log to record their practice at home, and they were phoned twice a week to remind their practice during the 4-week treatment period. Sleep Hygiene Education group Sleep Hygiene Education group The participants in this group will receive education on sleep hygiene. The treatment duration, frequency, and telephone follow-up schedule for the SHE group will be the same as the self-administered acupressure group (2 sessions, 2 hours each). Sleep hygiene education is often used as a comparison group in randomized controlled trials of self-help and psychological interventions for insomnia. The SHE group will provide subjects with the same amount of contact hours with the healthcare professional (instructor) in order to control the non-specific effects of practitioner-patient interaction in the self-administered acupressure group.
- Primary Outcome Measures
Name Time Method Insomnia Severity Index Week 4 The Insomnia Severity Index has 7 items that measured the severity of insomnia complaints and related daytime impairments. The total score ranges between 0 and 28, with the higher scores indicating more severe insomnia.
- Secondary Outcome Measures
Name Time Method Microbiota Week 4 16s rRNA sequencing of gut microbiota of the current study will be performed. The stool samples will be collected using commercially available kits. The kit contains a 5 ml buffer tube. The stool sample should be soaked in the buffer, therefore about 2-3 g stool will be collected. The kits will rapidly homogenize and stabilize the samples at the point-of-collection and transport and store stabilized DNA at ambient temperature for at least one month-no cold chain required.
A 7-day sleep diary Measued one-week before the assessment time point. the subjects will be asked to record their daily sleeping-waking schedule using a standard sleep diary for 7 days, and Sleep parameters, such as sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE), and sleep duration (TST) will be measured.
Hospital Anxiety and Depression Scale Week 4 The Hospital Anxiety and Depression Scale is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).
Trial Locations
- Locations (1)
School of Nursing, the Hong Kong Polytechnic University
ðŸ‡ðŸ‡°Hong Kong, Hong Kong