The Effects of Acupuncture on Insomnia Among Midlife Women: A Randomized Clinical Trail
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Pittsburgh sleep quality index (PSQI)
Study Overview
Brief Summary
Aims: To explore the effects of acupuncture on the improvement of insomnia, fatigue, depression and menopausal symptoms among midlife women.
Detailed Description
This research is a study with a randomized clinical trial. Participants were 40-60 years old with a sleep disturbance which persists more than one month. Twenty participants were randomly assigned into the experimental and control groups. The experimental group received acupuncture treatment (Taichong, Shenmen, Neiguan points) twice a week, total three weeks, plus sleep hygiene guidance; the control group received subcutaneous acupuncture (non-therapeutic acupuncture points) twice a week, total three weeks and given sleep Health guidance. All participants received pre-test and post-test, including sleep multiple physiological examination (PSG), Pittsburgh sleep quality table, Epworth sleepiness scale, hospital anxiety depression scale, menopausal symptom questionnaire, sleep disturbance comprehensive scale, and wore Actiwatch for three days. Data analysis was performed using SPSS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The patients will not know that they are recieving acupuncture or sham acupuncture
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women aged 40-60 years
- •Complaints of insomnia symptoms in the past month that lasted for at least one week, such as difficulty falling asleep, waking up easily in the middle of the night, unable to fall asleep after waking up, still not getting enough sleep after waking up in the morning
- •The score of sleep disorder on the Pittsburgh Sleep Quality Scale was more than 5 points
Exclusion Criteria
- •History of psychiatric disorders
- •History of sleep apnea or nocturnal myoclonus
- •Center or neurodegenerative disease
- •Melatonin or sleeping pills use in the past month
Outcomes
Primary Outcomes
Pittsburgh sleep quality index (PSQI)
Time Frame: 15 minutes
The scale is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, as well as for the evaluation of sleep quality in general people.
Secondary Outcomes
- Epworth Sleepiness Scale (ESS)(15 minutes)
- Hospital Anxiety and Depression Scale (HADS)(15 minutes)
- Total sleep time (TST)(8 hours)
- Minimum spo2 level during sleep(8 hours)
- Wake time after sleep onset (WASO)(8 hours)
- Sleep Latency(8 hours)
- Snore Outcomes Survey (SOS)(15 minutes)
- Percentage of rapid eye movement (REM) stage(8 hours)
- Mean heart rate during REM(8 hours)
- Global Physical Activity Questionnaire(15 minutes)
- Sleep efficiency (SE)(8 hours)