APA on Sleep Quality in Women With PCOS

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT06009172
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

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.

Study Timeline

• Study Start: 2022-07-24
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-31
• Status Verified: 2023-08
• Study First Submitted: 2023-08-19
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-24
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	Baseline and 30 days	The PSQI is a cornerstone tool for the assessment of sleep quality

Secondary Outcome Measures

Name	Time	Method
fasting serum insulin (pmol/L)	Baseline and 30 days
fasting blood-glucose(mmol/L)	Baseline and 30 days
Modified Polycystic Ovary Syndrome Health Related Quality of Life Questionnaire (MPCOSQ)	Baseline and 30 days
Self-Rating Anxiety Scale (SAS)	Baseline and 30 days	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.
Testosterone (T) level(ng/mL）	Baseline and 30 days
Progesterone (P) level(ng/mL）	Baseline and 30 days

Trial Locations

Locations (1)

Department of Endocrinology and Diabetes, the First Affiliated Hospital of Xiamen University, School of medicine, Xiamen university, Xiamen, China; 🇨🇳 Xiamen, Fujian, China