Self-acupressure for Insomnia in Perimenopausal Women

Not Applicable

Not yet recruiting

• Conditions: Insomnia; Perimenopausal Women

• 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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-17
• Last Update Posted: 2024-06-17
• Study Start: 2024-07-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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; 🇭🇰 Hong Kong, Hong Kong