Mindfulness-based Stress Reduction in Obese Women With Polycystic Ovary Syndrome (PICOS)
NCT ID: NCT06665789
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2024-10-31
2025-04-30
Brief Summary
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Detailed Description
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This study was designed as a single-blind pilot randomized controlled trial. It is planned to be conducted between November 2024 and January 2025 at Zeynep Kamil Women and Children's Diseases Education and Research Hospital.
Power analysis using G\*Power 3.0.10 showed that at least 44 samples were sufficient for 2 groups with Effect size 1. 72, 95% Power and 5% margin of error. Participants to be included in the groups were selected from the sample using a random sampling method with an equal distribution ratio (distribution ratio = 1:1).
Eligible women were randomized into the intervention group (n=22) and the control group (control) (n=22). Women assigned to the intervention group received the MBSR program. MBSR had eight weekly sessions of two hours each and a full-day retreat between the 7th and 8th sessions. The control group received routine care in the hospital but did not receive any other intervention during this period.
The pre-test data of the study were collected by the researcher using a face-to-face interview, a Personal Information Form containing demographic questions, and the measurement tools used in the study. At the end of the 8 weeks, the post-test data were collected using the same method.
The participants were given explanations about the MBSR program and it was stated how, for how long, and where to practice. The online MBSR program was completed by the participants in a way specific to each session (with mind, body, and breathing exercises). The MBSR program was implemented in this way for 8 weeks (eight sessions in total and one session per week). In addition, the participants were given homework (audio recording) to do throughout the week (until the next session) in the form of repeating mindfulness meditation practices. At the end of the eighth week, the measurement tools were re-administered to the participants who attended all eight sessions and completed their homework, and the post-test data were obtained.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Experimental
Mindfulness-based stress reduction training will be given to women selected for the experimental group for 8 weeks.
Mindfulness-based Stress Reduction
An 8-week Mindfulness-based stress reduction training programme
Control
Women in the control group receive routine care at the same hospital's polyclinics.
No interventions assigned to this group
Interventions
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Mindfulness-based Stress Reduction
An 8-week Mindfulness-based stress reduction training programme
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) ≥ 40 kg/m2
* Women with a diagnosis of polycystic ovary syndrome
Exclusion Criteria
* Pregnant women
* Thyroid dysfunction
* Cushing's syndrome
* Hyperprolactinemia
* Cancer history
* Pharmacological treatment for obesity
* Any type of bariatric surgery
* Absence of any psychiatric illness or comorbidities
* Current enrollment in a stress reduction program
* Mindfulness practice within the past 6 months (regular formal practice at least once a week)
18 Years
40 Years
FEMALE
Yes
Sponsors
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Saglik Bilimleri Universitesi
OTHER
Responsible Party
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Leyla Kaya
Assoc. Prof.
Principal Investigators
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Leyla Kaya, PhD
Role: PRINCIPAL_INVESTIGATOR
Saglik Bilimleri Universitesi
Locations
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Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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17.04.2024/34
Identifier Type: -
Identifier Source: org_study_id
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