Self-acupressure for Insomnia in Perimenopausal Women

Insomnia Clinical Trial

— SAP  

Official title:

Self-acupressure for Insomnia in Perimenopausal Women: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463197
• Other study ID #: SAP
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: June 2024
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 64 Years

Eligibility

The inclusion criteria were as follows: (i) Chinese Hong Kong residents who were able to read Chinese; (ii) age 35 to 64 years; (iii) 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; and (iv) with a current clinical DSM-5 diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire. The criteria included having difficulties falling asleep, staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months. (v) An Insomnia Severity Index total score of at least 10 indicated that insomnia was present at the clinical level and (vi) Able to understand Chinese and Cantonese or Mandarin; (vii) willing to give informed consent and comply with the trial protocol. For (iv) and (v), both the Brief Insomnia Questionnaire and Insomnia Severity Index were included as inclusion criteria. This is because the two scales have different purposes. Specifically, Brief Insomnia Questionnaire is used to confirm the participants fulfil the diagnostic criteria of DSM-5 insomnia disorder, while the Insomnia Severity Index is used to assess the severity of the insomnia symptoms and related daytime impairments. The exclusion criteria are: (i) pregnancy; (ii) at significant suicide risk according to the rating by the Hamilton Depression Rating Scale item on suicide (score =3); (iii) no comorbid sleep disorders primarily requiring other treatments, such as sleep apnea or narcolepsy; (iv) change in the dose of their psychotropic drugs within 12 weeks prior to baseline, which would possibly indicate instability in their psychiatric condition; and (v) taking any antibiotics in 3 months before the baseline or any food containing probiotics, such as yogurt, in 7 days before the baseline.

Related Conditions & MeSH terms

• Insomnia
• Perimenopausal Women
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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
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.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, the Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Measued one-week before the assessment time point.
Secondary	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).	Baseline
Secondary	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).	Week 2
Secondary	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).	Week 4
Secondary	Microbiota	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.	Baseline
Secondary	Microbiota	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.	Week 2
Secondary	Microbiota	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.	Week 4