An interventional study of Acupuncture in Menopause Syndrome, sponsored by National Cheng-Kung University Hospital. Completed at 1 site in Taiwan. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-01-13.
Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Treatment
Aims: To explore the effects of acupuncture on the improvement of insomnia, fatigue, depression and menopausal symptoms among midlife women.
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 592 are open to participants now.
This study's enrollment of 42 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
The experimental group received acupuncture treatment (Taichong, Shenmen, Neiguan points) twice a week, total three weeks, plus sleep hygiene guidance
Other: Acupuncture
The control group received subcutaneous acupuncture (non-therapeutic acupuncture points) twice a week, total three weeks and given sleep Health guidance.
Other: Acupuncture
Acupoint:Taichong, Shenmen, Neiguan points with twice a week for total three weeks
Pittsburgh sleep quality index (PSQI)
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.
Time frame: 15 minutes
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment questionnaire that has been found to be a reliable instrument for detecting states of anxiety and depression in the setting of hospital outpatient clinic.
Time frame: 15 minutes
Epworth Sleepiness Scale (ESS)
The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities.
Time frame: 15 minutes
Snore Outcomes Survey (SOS)
The SOS consists of 8 items relating to the intensity, duration, frequency, and impact of SDB symptoms - specifi cally snoring.
Time frame: 15 minutes
Global Physical Activity Questionnaire
The Global Physical Activity Questionnaire was developed by WHO for physical activity surveillance in countries. It collects information on physical activity participation in three settings (or domains) as well as sedentary behaviour, comprising 16 questions (P1-P16)
Time frame: 15 minutes
Total sleep time (TST)
TST was determined as the number of minutes asleep in bed after "lights off," considering only nighttime sleep.
Time frame: 8 hours
Wake time after sleep onset (WASO)
Wake time after sleep onset is time during which one is awake.
Time frame: 8 hours
Sleep Latency
Sleep latency, or sleep onset latency, is the time it takes a person to fall asleep after turning the lights out.
Time frame: 8 hours
Percentage of rapid eye movement (REM) stage
REM sleep is the stage in which most people vividly dream. These periods of sleep typically start around 90 minutes after someone falls asleep.
Time frame: 8 hours
Sleep efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), plays a central role in insomnia research and practice. The significance of SE is understandable because it captures a core problem for those suffering from insomnia-spending too much time in bed trying to sleep.
Time frame: 8 hours
Minimum spo2 level during sleep
A normal level of oxygen is usually 95% or higher. Some people with chronic lung disease or sleep apnea can have normal levels around 90%.
Time frame: 8 hours
Mean heart rate during REM
Rapid eye movement (REM) sleep is characterized by periods of profound cardiac autonomic activation evident in heart rate surges in humans and canines.
Time frame: 8 hours
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
National Cheng-Kung University Hospital