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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dependent Variables of the Study: Anxiety, Depression, Stress and Salivary Cortisol Levels; Independent Variables of the Study: Women's Socio-demographic Characteristics, Mindfulness-based Stress Reduction Program
• Intervention / Treatment: Other: mindfulness-based stress reduction

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

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YASEMİN AYDIN KARTAL, Doc. Dr.; Phone Number: +90 543 287 00 29; Email: yasemin.aydin@sbu.edu.tr
• Study Contact Backup: Name: ROJDA BAYAR YILDIRIM, PhD StD.; Phone Number: +90 539 395 69 25; Email: rojdabayar95@outlook.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Sağlık Bilimleri Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After the implemantation (4. week)
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.	After the implemantation (4. week)
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.	After the implemantation (4. week)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After the implemantation (8. week)
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.	After the implemantation (8. week)
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.	After the implemantation (8. week)

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: YASEMİN AYDIN KARTAL, Doc. Dr., Health S.; Study Chair: ROJDA BAYAR YILDIRIM, PhD StD., Research H.; Study Chair: İBRAHİM KALE, Doc. Dr., Research H.

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2024
• Primary Completion (Estimated): May 10, 2025
• Study Completion (Estimated): June 10, 2025

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Infertility; women, mindfulness, cortisol, anxiety, depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: RojdaBAYARYILDIRIM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No