Back to resultsAPA on Sleep Quality in Women With PCOS
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Auricular point acupressure (APA)
Sponsored by
About this trial
This is an interventional health services research trial for Polycystic Ovary Syndrome
Eligibility Criteria
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.
Sites / Locations
- Department of Endocrinology and Diabetes, the First Affiliated Hospital of Xiamen University, School of medicine, Xiamen university, Xiamen, China
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
APA group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a cornerstone tool for the assessment of sleep quality
Secondary Outcome Measures
Modified Polycystic Ovary Syndrome Health Related Quality of Life Questionnaire (MPCOSQ)
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.
Testosterone (T) level(ng/mL）
Progesterone (P) level(ng/mL）
fasting serum insulin (pmol/L)
fasting blood-glucose(mmol/L)
Full Information
NCT ID
NCT06009172
First Posted
August 19, 2023
Last Updated
August 25, 2023
Sponsor
The First Affiliated Hospital of Xiamen University
1. Study Identification
Unique Protocol Identification Number
NCT06009172
Brief Title
APA on Sleep Quality in Women With PCOS
Official Title
The Effect of Auricular Point Acupressure on Sleep Quality in Women With Polycystic Ovary Syndrome：A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 24, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Xiamen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
APA group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Auricular point acupressure (APA)
Intervention Description
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 Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI is a cornerstone tool for the assessment of sleep quality
Time Frame
Baseline and 30 days
Secondary Outcome Measure Information:
Title
Modified Polycystic Ovary Syndrome Health Related Quality of Life Questionnaire (MPCOSQ)
Time Frame
Baseline and 30 days
Title
Self-Rating Anxiety Scale (SAS)
Description
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.
Time Frame
Baseline and 30 days
Title
Testosterone (T) level(ng/mL）
Time Frame
Baseline and 30 days
Title
Progesterone (P) level(ng/mL）
Time Frame
Baseline and 30 days
Title
fasting serum insulin (pmol/L)
Time Frame
Baseline and 30 days
Title
fasting blood-glucose(mmol/L)
Time Frame
Baseline and 30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Endocrinology and Diabetes, the First Affiliated Hospital of Xiamen University, School of medicine, Xiamen university, Xiamen, China
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
12. IPD Sharing Statement
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APA on Sleep Quality in Women With PCOS
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