Clinical trial NCT06283693: The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women
Official title: The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women on Perceived Stress, Anxiety, Depression and Cortisol Levels
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression Anxiety Disorder
Demography, Family
Awakening Early
Keywords: Infertility
women,
mindfulness
cortisol
anxiety
depression
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled classical experimental study
Primary purpose: OTHER

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

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

Exclusion Criteria

- 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

Primary outcomes:
measure: Informed Voluntary Consent Form (Annex 1)
timeFrame: Before implementation
measure: Identifying Characteristics Information Form (Annex 2)
timeFrame: Before implementation
measure: Perceived Stress Scale (Appendix 3):
timeFrame: Before implementation
measure: Depression-Anxiety-Stress Scale (Appendix 4)
timeFrame: Before implementation
measure: Collection and study of salivary cortisol samples
timeFrame: Before implementation
Secondary outcomes:
measure: Perceived Stress Scale (Appendix 3):
timeFrame: After the implemantation (4. week)
measure: Depression-Anxiety-Stress Scale (Appendix 4)
timeFrame: After the implemantation (4. week)
measure: Collection and study of salivary cortisol samples
timeFrame: After the implemantation (4. week)
Other outcomes:
measure: Perceived Stress Scale (Appendix 3):
timeFrame: After the implemantation (8. week)
measure: Depression-Anxiety-Stress Scale (Appendix 4)
timeFrame: After the implemantation (8. week)
measure: Collection and study of salivary cortisol samples
timeFrame: After the implemantation (8. week)
Locations:
city: Istanbul
country: Turkey
facility: Saglık Bilimleri Universitesi
Study officials:
affiliation: Health S.
name: YASEMİN AYDIN KARTAL, Doc. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Research H.
name: ROJDA BAYAR YILDIRIM, PhD StD.
role: STUDY_CHAIR
affiliation: Research H.
name: İBRAHİM KALE, Doc. Dr.
role: STUDY_CHAIR
References: