APA on Sleep Quality in Women With PCOS

NCT06009172 | Completed

• 1 other identifier: XMYY-2022KY055-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

  The PSQI is a cornerstone tool for the assessment of sleep quality

  Baseline and 30 days

Secondary Outcomes (6)

• Modified Polycystic Ovary Syndrome Health Related Quality of Life Questionnaire (MPCOSQ)

  Baseline and 30 days

• Self-Rating Anxiety Scale (SAS)

  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

Study Arms (2)

APA group

EXPERIMENTAL

Other: Auricular point acupressure (APA)

Control group

NO INTERVENTION

Interventions

Auricular point acupressure (APA) OTHER

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.

APA group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

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

Xiamen, Fujian, 361003, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2023
• First Posted: August 24, 2023
• Study Start: July 24, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 31, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

CN (1)