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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06009172
Enrollment
88
Registered
2023-08-24
Start date
2022-07-24
Completion date
2023-07-31
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

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.

Interventions

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.

Sponsors

The First Affiliated Hospital of Xiamen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Pittsburgh Sleep Quality Index (PSQI)Baseline and 30 daysThe PSQI is a cornerstone tool for the assessment of sleep quality

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026