APA on Sleep Quality in Women With PCOS

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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Other: Auricular point acupressure (APA)

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Department of Endocrinology and Diabetes, the First Affiliated Hospital of Xiamen University, School of medicine, Xiamen university, Xiamen, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: APA group	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: August 19, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: XMYY-2022KY055-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No