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Completed

NCT Number: NCT06009172

APA on Sleep Quality in Women With PCOS

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Xiamen, Fujian, 361003, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Subjects were included if they

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

Subjects were excluded if they

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

Treatment and study plan

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.

Primary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and 30 days

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

Secondary outcomes

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

    Time frame: Baseline and 30 days

  2. Self-Rating Anxiety Scale (SAS)

    Time frame: 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.

  3. Testosterone (T) level(ng/mL)

    Time frame: Baseline and 30 days

  4. Progesterone (P) level(ng/mL)

    Time frame: Baseline and 30 days

  5. fasting serum insulin (pmol/L)

    Time frame: Baseline and 30 days

  6. fasting blood-glucose(mmol/L)

    Time frame: Baseline and 30 days

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2023
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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