Self-acupressure for Insomnia in Perimenopausal Women

NCT06463197 | Not Yet Recruiting DMC

• 1 other identifier: SAP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Perimenopausal Women

Keywords

perimenopausal women; insomnia; sleep disorders

Outcome Measures

Primary Outcomes (3)

• Insomnia Severity Index

  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.

  Baseline

• Insomnia Severity Index

  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.

  Week 2

• Insomnia Severity Index

  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.

  Week 4

Secondary Outcomes (7)

• A 7-day sleep diary

  Measued one-week before the assessment time point.

• Hospital Anxiety and Depression Scale

  Baseline

• Hospital Anxiety and Depression Scale

  Week 2

• Hospital Anxiety and Depression Scale

  Week 4

• Microbiota

  Baseline

Study Arms (2)

Self-acupressure group

EXPERIMENTAL

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.

Behavioral: Self-Administered Acupressure Group

Sleep Hygiene Education group

ACTIVE COMPARATOR

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.

Behavioral: Sleep Hygiene Education group

Interventions

Self-Administered Acupressure Group BEHAVIORAL

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.

Also known as: SAPG

Self-acupressure group

Sleep Hygiene Education group BEHAVIORAL

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.

Also known as: SHEG

Sleep Hygiene Education group

Eligibility Criteria

• Age: 35 Years - 64 Years
• Gender Eligibility Details: peri-menopausal women, defined as menstrual cycle irregularity (a change of 7 days or more in the menstrual cycle) or amenorrhea for no longer than 60 consecutive days, according to the recommendations from the Stages of Reproductive Aging Workshop
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, the Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers who will collect data from participants will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)