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

NCT06283693 | Completed

• 1 other identifier: RojdaBAYARYILDIRIM
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Awakening Early; Depression Anxiety Disorder; Demography, Family

Keywords

Infertility; women,; mindfulness; cortisol; anxiety; depression

Outcome Measures

Primary Outcomes (5)

• Informed Voluntary Consent Form (Annex 1)

  This form, which was created by the researchers, includes information about the intervention and control groups, explaining the content and purpose of the study to the participants, the time of the weekly program and how many days the program will last, when the research will end, which data collection tools will be used, for what purpose the data will be used, how information privacy will be ensured, the information of the researcher, and the consent of the participants and their voluntariness.

  Before implementation

• Identifying Characteristics Information Form (Annex 2)

  This form, prepared by the researchers in line with the literature, consists of 20 items. In addition to socio-demographic information such as age, education level, occupation, marriage duration, infertility history is questioned (Garland et al., Domar 2008; Sherratt \& Lunn, 2013, Ozan \& Okumuş, 2013, Güngör \& Bejı̇ , 2015; Fanning et al., 2018;, ; Hosseini et al., 2020;; Örüklü, 2020).

  Before implementation

• Perceived Stress Scale (Appendix 3):

  The Perceived Stress Scale was developed as a five-point Likert-type rating scale with 14 items. The scale consists of "never (0), almost never" (1), "sometimes" (2), "often" (3) and "very often" (4) options. In this 14-item form, items 4-5-6-7-9-10 and 13 are reverse scored. The lowest and highest scores that a participant can obtain from this scale are 0 and 56, respectively. A high total score means a high Perceived Stress Level Scale. It can be said that participants with a score range between 0 and 35 have a positive stress level, can cope with stress effectively and the coping mechanisms they use are functional. It can be said that the methods used by the participants with a score range between 36-56 are not functional and therefore they cannot cope with stress effectively.

  Before implementation

• Depression-Anxiety-Stress Scale (Appendix 4)

  The Cronbach's alpha internal consistency coefficients of the 3 sub-dimensions of the scale were tested as .84 for the anxiety sub-dimension, .91 for the depression sub-dimension and .90 for the stress sub-dimension. The scale is a 4-point Likert-type form for self-assessment. The sub-dimensions and item distribution are as follows: Depression: 7 items in total, including items 3, 5, 10, 13, 16, 17 and 21. Anxiety: 2., 4., 7., 9., 15., 19. and 20. Stress: 1st, 6th, 8th, 11th, 12th, 14th and 18th items, totaling 7 items. In the internal consistency calculations of the scale, the Cronbach Alpha coefficient of the depression sub-dimension was .67; the Cronbach Alpha coefficient of the anxiety sub-dimension was .86; the Cronbach Alpha coefficient of the stress sub-dimension was .67 and the Cronbach Alpha coefficient for the whole scale was .87. There were no reverse items in the scale.

  Before implementation

• Collection and study of salivary cortisol samples

  For the determination of cortisol level; salivary cortisol measurement will be taken from the women in the intervention and control groups for the first test. Then, after the 4 -week MBSR program, salivary cortisol will be taken again from the intervention and control groups for the post-test. Then salivary cortisol test will be taken for follow-up at the 12th week. Saliva samples will be collected by the researcher. In our study, DRG brand Salivary tubes made of polypropylene (PP) / low density polyethylene (LD-PE) material especially designed for cortisol will be used for the collection and storage of saliva samples (Figure 1). These tubes provide high analytical performance from small volumes of samples. Patients will be asked to wet the cotton ball in the salivary tube (Figure 2) completely with saliva by holding it in their mouth for one minute. The samples will be refrigerated and centrifuged at 4000 g for 10 minutes in the biochemistry laboratory.

  Before implementation

Secondary Outcomes (3)

• Perceived Stress Scale (Appendix 3):

  After the implemantation (4. week)

• Depression-Anxiety-Stress Scale (Appendix 4)

  After the implemantation (4. week)

• Collection and study of salivary cortisol samples

  After the implemantation (4. week)

Other Outcomes (3)

• Perceived Stress Scale (Appendix 3):

  After the implemantation (8. week)

• Depression-Anxiety-Stress Scale (Appendix 4)

  After the implemantation (8. week)

• Collection and study of salivary cortisol samples

  After the implemantation (8. week)

Study Arms (2)

Experimantal group:

EXPERIMENTAL

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.

Other: mindfulness-based stress reduction

Control group:

NO INTERVENTION

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.

Interventions

mindfulness-based stress reduction 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.

Experimantal group:

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Being an infertile woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglık Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Infertility; Anxiety Disorders; Depression

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Genital Diseases; Urogenital Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• YASEMİN AYDIN KARTAL, Doc. Dr.

  Health S.

  PRINCIPAL INVESTIGATOR

• ROJDA BAYAR YILDIRIM, PhD StD.

  Research H.

  STUDY CHAIR

• İBRAHİM KALE, Doc. Dr.

  Research H.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Computer-assisted randomization will be used in the study, and participants will be randomized to an intervention or control list control group in a 1:1 ratio by entering the number of samples to be reached through the program whose URL address is https://www.randomizer.org. Women who apply to the infertility outpatient clinic by the researcher and volunteer for the study who meet the sample selection criteria will be given numbers according to the order of outpatient clinic registration. A randomization sequence will be created according to these numbers and women will be assigned to the intervention and control groups by computer-assisted randomization. Since the study is a thesis, blinding will not be possible due to its nature.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. prof. dr

Model Details: Randomized controlled classical experimental study

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: April 20, 2024
• Primary Completion: May 10, 2025
• Study Completion: June 10, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

TU (1)