APA on Sleep Quality in Women With PCOS

Study Overview
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Brief Summary
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Women with polycystic ovary syndrome (PCOS) appear to have an increased frequency of sleep problems. The aim of this study was to explore the effect of auricular point acupressure (APA) pressure on sleep quality in women with PCOS.

Detailed Description
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Polycystic ovary syndrome (PCOS) is a prevalent disorder affecting 5-18% of reproductive-age women. In recent years, women with PCOS appear to have an increased frequency of sleep problems, and the prevalence of poor sleep in PCOS is high at 31%. The aim of this study was to explore the effect of auricular point acupressure (APA) pressure on sleep quality in women with PCOS. We verified the effect of APA pressure on sleep quality, quality of life, anxiety level, sex hormone indexes, and biochemical indexes in two groups after the intervention. So as to provide a sleep management strategy in PCOS women for future clinical practice guidelines.

Official Title
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The Effect of Auricular Point Acupressure on Sleep Quality in Women With Polycystic Ovary Syndrome：A Randomized Controlled Trial

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: Auricular point acupressure (APA)


Participation Criteria
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Eligibility Criteria
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Subjects were included if they were aged between 18-40 years old; met the clinical diagnostic criteria of Western and Chinese medicine for PCOS with sleep disorders; were evaluated by the Pittsburgh Sleep Quality Index Scale (PSQI) and had a score ≥ 7 points; did not participate in other clinical trials. Subjects were excluded if they had a serious organic condition such as cardiovascular, cerebrovascular, liver, or kidney disease; had acute gynecological inflammation, gynecological tumors, or reproductive system malformations; had severe anxiety, depression, or other mental illnesses; were pregnant; had used sleeping and sedative drugs in the past month; were allergic to ear point tape; had local rupture of the skin at the selected ear point; refused to fill out questionnaires and sign informed consent forms.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APA group<br> | Other: Auricular point acupressure (APA)<br>* Auricular point acupressure (APA) is a method derived from Traditional Chinese Medicine. PCOS women in the APA group began to apply pressure on the first day of enrollment. Patients were instructed to press each acupuncture point 3 times a day for 30 times. The PCOS woman is then trained to go to the outpatient clinic every 5-7 days to change the auricular acupressure sticker. The intervention period was 4 weeks.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a cornerstone tool for the assessment of sleep quality | Baseline and 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Polycystic Ovary Syndrome Health Related Quality of Life Questionnaire (MPCOSQ) |  | Baseline and 30 days | 
| Self-Rating Anxiety Scale (SAS) | The cutoff value for anxiety assessment of Self-Rating Anxiety Scale (SAS) is 50 oints, and the higher the score, the more obvious the anxiety tendency. Below 49 is normal; 50-59 is mild; 60-69 is moderate; A score of 69 or above is considered severe. | Baseline and 30 days | 
| Testosterone (T) level(ng/mL） |  | Baseline and 30 days | 
| Progesterone (P) level(ng/mL） |  | Baseline and 30 days | 
| fasting serum insulin (pmol/L) |  | Baseline and 30 days | 
| fasting blood-glucose(mmol/L) |  | Baseline and 30 days |