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Trial Title:
Mindfulness-based Stress Reduction in Obese Women With Polycystic Ovary Syndrome (PICOS)
NCT ID:
NCT06665789
Condition:
Obesity
Polycystic Ovary Syndrome
Stress
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Conditions: Keywords:
Emotional Appetite
Polycystic Ovary Syndrome
Obesity
Stress
Cognitive Triad
Mindfulness
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Masking description:
Single (Participant)
Intervention:
Intervention type:
Behavioral
Intervention name:
Mindfulness-based Stress Reduction
Description:
An 8-week Mindfulness-based stress reduction training programme
Arm group label:
Experimental
Summary:
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).
Detailed 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.
Criteria for eligibility:
Criteria:
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)
Gender:
Female
Gender based:
Yes
Gender description:
Famale
Minimum age:
18 Years
Maximum age:
40 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Address:
City:
İstanbul
Zip:
34668
Country:
Turkey
Contact:
Last name:
Leyla Kaya, PhD
Phone:
+905456449327
Email:
leylakaya02@hotmail.com
Investigator:
Last name:
Yıldız Bilge, Phd
Email:
Sub-Investigator
Investigator:
Last name:
Esra Keles, MD
Email:
Sub-Investigator
Start date:
November 20, 2024
Completion date:
January 20, 2025
Lead sponsor:
Agency:
Saglik Bilimleri Universitesi
Agency class:
Other
Source:
Saglik Bilimleri Universitesi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06665789
