Self-acupressure for Insomnia in Perimenopausal Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-64
SponsorThe Hong Kong Polytechnic University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Self-Administered Acupressure Group
BehavioralSubjects 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
BehavioralThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Self-acupressure groupExperimental treatment 1 intervention
Group B: Sleep Hygiene Education groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Week 23
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.
Time frame
Week 4Secondary outcomes
1
A 7-day sleep diary
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.
Time frame
Measued one-week before the assessment time point.2
Hospital Anxiety and Depression Scale
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).
Time frame
Baseline3
Hospital Anxiety and Depression Scale
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).
Time frame
Week 24
Hospital Anxiety and Depression Scale
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).
Time frame
Week 4Sponsors and contacts
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Source ClinicalTrials.gov
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