Clinical trial NCT06009172: APA on Sleep Quality in Women With PCOS
Official title: The Effect of Auricular Point Acupressure on Sleep Quality in Women With Polycystic Ovary Syndrome：A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: Subjects were included if they

1. were aged between 18-40 years old;
2. met the clinical diagnostic criteria of Western and Chinese medicine for PCOS with sleep disorders;
3. were evaluated by the Pittsburgh Sleep Quality Index Scale (PSQI) and had a score ≥ 7 points;
4. did not participate in other clinical trials.

Subjects were excluded if they

1. had a serious organic condition such as cardiovascular, cerebrovascular, liver, or kidney disease;
2. had acute gynecological inflammation, gynecological tumors, or reproductive system malformations;
3. had severe anxiety, depression, or other mental illnesses;
4. were pregnant;
5. had used sleeping and sedative drugs in the past month;
6. were allergic to ear point tape;
7. had local rupture of the skin at the selected ear point;
8. refused to fill out questionnaires and sign informed consent forms.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and 30 days
Secondary outcomes:
measure: Modified Polycystic Ovary Syndrome Health Related Quality of Life Questionnaire (MPCOSQ)
timeFrame: Baseline and 30 days
measure: Self-Rating Anxiety Scale (SAS)
timeFrame: Baseline and 30 days
measure: Testosterone (T) level(ng/mL）
timeFrame: Baseline and 30 days
measure: Progesterone (P) level(ng/mL）
timeFrame: Baseline and 30 days
measure: fasting serum insulin (pmol/L)
timeFrame: Baseline and 30 days
measure: fasting blood-glucose(mmol/L)
timeFrame: Baseline and 30 days
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Department of Endocrinology and Diabetes, the First Affiliated Hospital of Xiamen University, School of medicine, Xiamen university, Xiamen, China
state: Fujian
Study officials:
References: