Mindfulness-based Stress Reduction in Obese Women With Polycystic Ovary Syndrome (PICOS)

Saglik Bilimleri Universitesi

Status: Completed

Conditions: Polycystic Ovary Syndrome; Obesity; Stress

Treatments: Behavioral: Mindfulness-based Stress Reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT06665789

17.04.2024/34

Details and patient eligibility

About

The aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) program on Stress, depression, anxiety, cognitive triad and emotional appetite in obese women with polycystic ovary syndrome (PCOS).

Full description

The aim of this study was to evaluate the effects of mindfulness-based stress reduction (MBSR) program on stress, depression, anxiety, cognitive triad and emotional appetite in obese women with polycystic ovary syndrome (PCOS).

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women between the ages of 18-40
• Body mass index (BMI) ≥ 40 kg/m2
• Women with a diagnosis of polycystic ovary syndrome

Exclusion criteria

• Psychiatric illness
• 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Experimental

Experimental group

Description:

Mindfulness-based stress reduction training will be given to women selected for the experimental group for 8 weeks.

Treatment:

Behavioral: Mindfulness-based Stress Reduction

Control

No Intervention group

Description:

Women in the control group receive routine care at the same hospital's polyclinics.