APA on Sleep Quality in Women With PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06009172
• Other study ID #: XMYY-2022KY055-01
• Status: Completed
• Phase: N/A
• Start date: July 24, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: The First Affiliated Hospital of Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 31, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• Auricular point acupressure (APA)
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.

Locations

Country	Name	City	State
China	Department of Endocrinology and Diabetes, the First Affiliated Hospital of Xiamen University, School of medicine, Xiamen university, Xiamen, China	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index (PSQI)	The PSQI is a cornerstone tool for the assessment of sleep quality	Baseline and 30 days
Secondary	Modified Polycystic Ovary Syndrome Health Related Quality of Life Questionnaire (MPCOSQ)		Baseline and 30 days
Secondary	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
Secondary	Testosterone (T) level(ng/mL)		Baseline and 30 days
Secondary	Progesterone (P) level(ng/mL)		Baseline and 30 days
Secondary	fasting serum insulin (pmol/L)		Baseline and 30 days
Secondary	fasting blood-glucose(mmol/L)		Baseline and 30 days