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Depression Anxiety DisorderNCT06283693

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

A study testing mindfulness-based stress reduction in people with Depression Anxiety Disorder and Demography, Family, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
mindfulness-based stress reduction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Apr 2024to 10 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • - 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

Who cannot join

  • - 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Saglık Bilimleri Universitesi

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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

Being tested
mindfulness-based stress reduction
Keywords
Infertility, women,, mindfulness, cortisol, anxiety, depression
Medical subject headings
Sleep Initiation and Maintenance Disorders, Infertility, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mindfulness-based stress reductionOther

    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.

Study groups in NCT06283693
Study groupRoleWhat they receive
Experimantal group:ExperimentalIntervention 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.
Receives: Other: mindfulness-based stress reduction
Control group:No interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before implementation

  2. 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).

    Measured: Before implementation

  3. 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.

    Measured: Before implementation

  4. 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.

    Measured: Before implementation

  5. 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.

    Measured: Before implementation

Secondary outcomes (3)
  1. 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.

    Measured: After the implemantation (4. week)

  2. 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.

    Measured: After the implemantation (4. week)

  3. 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.

    Measured: After the implemantation (4. week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start20 Apr 2024
  3. Primary completion10 May 2025
  4. Study completion10 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled classical experimental study
Masking
Single blind
Who is masked
Participant
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06283693
Sponsor's protocol ID
RojdaBAYARYILDIRIM
Status last verified
Jan 2026
First submitted
20 Feb 2024
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing mindfulness-based stress reduction in people with Depression Anxiety Disorder and Demography, Family, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Informed Voluntary Consent Form (Annex 1) (time frame: Before implementation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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