Clinical trial NCT06463197: Self-acupressure for Insomnia in Perimenopausal Women
Official title: Self-acupressure for Insomnia in Perimenopausal Women: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia
Perimenopausal Women
Keywords: perimenopausal women
insomnia
sleep disorders
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Baseline
measure: Insomnia Severity Index
timeFrame: Week 2
measure: Insomnia Severity Index
timeFrame: Week 4
Secondary outcomes:
measure: A 7-day sleep diary
timeFrame: Measued one-week before the assessment time point.
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: Week 2
measure: Hospital Anxiety and Depression Scale
timeFrame: Week 4
measure: Microbiota
timeFrame: Baseline
measure: Microbiota
timeFrame: Week 2
measure: Microbiota
timeFrame: Week 4
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, the Hong Kong Polytechnic University
Study officials:
References: