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

NCT ID: NCT06283693

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2025-06-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Experimantal group:

Intervention Group : The women in this group will receive a 4-week Mindfulness-Based Stress Reduction program in addition to routine outpatient clinic follow-up at the relevant institution. Before the implementation of the Mindfulness-Based Stress Reduction program, the women in the intervention group will be administered the Informed Voluntary Consent Form, Descriptive Characteristics Information Form, Perceived Stress Scale, DASS-21 and salivary cortisol measurements for pre-test measurements. After the mindfulness program, follow-up tests will be conducted in the 4th week. In the 8th week, the post-test will be conducted. In the post-test and follow-up test; Perceived Stress Scale, DASS-21 and salivary cortisol measurements will be applied.

Group Type: EXPERIMENTAL

mindfulness-based stress reduction

Intervention Type: OTHER

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.

Control group:

The women in this group will not be subjected to any intervention and will be followed up in the routine outpatient clinic of the relevant institution. Informed Voluntary Consent Form, Descriptive Characteristics Information Form, Perceived Stress Scale, DASS-21 and salivary cortisol measurements will be applied for the pre-test measurements of the control group women. In the study, post-test measurements will be made 4 weeks after the pre-test measurements of the control group and follow-up measurements will be made 8 weeks later. Perceived Stress Scale, DASS-21 and salivary cortisol measurements will be applied to the women in the control group for pre-test, post-test and follow-up measurements.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• - Agree to participate in the 8-week MBSR training
• Having completed the Informed Consent Form and volunteering to participate in the study
• Speaking and understanding Turkish
• Idiopathic infertile women
• Primary infertile women
• YTU treatment has not started
• Having attempted YTU at most three times before
• Be able to use ZOOM program

Exclusion Criteria

• - Illiteracy,
• The woman has a cognitive and auditory problem,
• Having a chronic disease
• Not having a psychiatric diagnosis (schizophrenia, bipolar disorder, major depression, anxiety disorders, etc.)
• Having participated in any awareness-based training program in the last 1 year

• Not participating in any session of the 8-session training program, not participating in any of the Pre-test, Post-test-1 and Post-test-2

Being an infertile woman

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

YASEMİN AYDIN KARTAL

assoc. prof. dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

YASEMİN AYDIN KARTAL, Doc. Dr.

Role: PRINCIPAL_INVESTIGATOR

Health S.

ROJDA BAYAR YILDIRIM, PhD StD.

Role: STUDY_CHAIR

Research H.

İBRAHİM KALE, Doc. Dr.

Role: STUDY_CHAIR

Research H.

Locations

Saglık Bilimleri Universitesi

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

RojdaBAYARYILDIRIM

Identifier Type: -

Identifier Source: org_study_id