NCT06283693

The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women

The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women on Perceived Stress, Anxiety, Depression and Cortisol Levels

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Saglik Bilimleri Universitesi · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Purpose of the Study This study aims to determine the effect of mindfulness-based stress reduction program given to infertile women on perceived stress, anxiety, depression and salivary cortisol. Materials and Method It will be conducted in a randomized controlled experimental design. This randomized controlled trial will follow the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines.

Detailed description

This study was planned as a randomized controlled experimental study to determine the effect of mindfulness-based stress reduction program given to infertile women on perceived stress, anxiety, depression and salivary cortisol levels. It will be conducted in a randomized parallel controlled experimental design using Consolidated Standards of Reporting Trials (CONSORT) guidelines. Women applying to the infertility outpatient clinic of Health Sciences University Ümraniye Training and Research Hospital in Ümraniye district of Istanbul province will constitute the sample population of the study. Women applying to the infertility outpatient clinic who meet the inclusion criteria and who voluntarily agree to participate in the study will be included in the study. According to the power analysis, a total of 86 infertile women, 43 in the intervention group and 43 in the control group, will constitute the sample of the study. While Mindfulness-Based Stress Reduction Program will be applied to the intervention group with the zoom program, which is an online training platform, routine follow-up will be applied to the control group within the scope of outpatient follow-up of the relevant institution. The participants included in the study will be administered the Informed Voluntary Consent Form, Descriptive Characteristics Information Form, DASS-21, Perceived stress scale and Salivary cortisol test as part of the pre-test. Within the scope of post-test and follow-up test, DASS-21, Perceived stress scale and Salivary cortisol test will be applied again. Discussion and conclusions of the study will be written as a result of the findings

Conditions

• Depression Anxiety Disorder
• Demography, Family
• Awakening Early

Interventions

Type	Name	Description
OTHER	mindfulness-based stress reduction	Müdahale grubundaki kadınlara depresyon, anksiyete ve stres düzeylerini azaltmak için farkındalık temelli bir stres azaltma programı uygulanacaktır. Program, haftada bir seans olmak üzere haftada iki kez toplam 4 hafta boyunca 8 seanstan oluşacaktır. Müdahale grubu haftada 2 seans alacaktır. Her seans 80 dakika sürecektir. Çalışmadaki seanslar, katılımcıların iş yoğunluğu, hayattaki sorumlulukları ve 4 hafta boyunca düzenli olarak katılamama ihtimalleri göz önünde bulundurularak zoom programı üzerinden gerçekleştirilecektir. 4 hafta/8 oturumluk MBSR programı tamamlandıktan sonra müdahale grubundaki kadınlara veri toplama formları tekrar uygulanacak ve son test ölçümleri yapılacaktır. Son test ölçümlerinden sonra müdahale grubundaki kadınların takip ölçümleri ölçümlerden 8 hafta sonra yapılacaktır.

Timeline

• Start date: 2024-04-20
• Primary completion: 2025-05-10
• Completion: 2025-06-10
• First posted: 2024-02-28
• Last updated: 2026-01-12

Locations

1 site across 1 country: Turkey (Türkiye)