protocolSection identificationModule nctId: NCT06283693, orgStudyIdInfo id: RojdaBAYARYILDIRIM, briefTitle: The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-05-10, completionDateStruct date: 2025-06-10, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Dependent Variables of the Study: Anxiety, Depression, Stress and Salivary Cortisol Levels, conditions: Independent Variables of the Study: Women's Socio-demographic Characteristics, Mindfulness-based Stress Reduction Program, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled classical experimental study, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: 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., whoMasked: PARTICIPANT, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: mindfulness-based stress reduction, outcomesModule primaryOutcomes measure: Informed Voluntary Consent Form (Annex 1), primaryOutcomes measure: Identifying Characteristics Information Form (Annex 2), primaryOutcomes measure: Perceived Stress Scale (Appendix 3):, primaryOutcomes measure: Depression-Anxiety-Stress Scale (Appendix 4), primaryOutcomes measure: Collection and study of salivary cortisol samples, secondaryOutcomes measure: Perceived Stress Scale (Appendix 3):, secondaryOutcomes measure: Depression-Anxiety-Stress Scale (Appendix 4), secondaryOutcomes measure: Collection and study of salivary cortisol samples, otherOutcomes measure: Perceived Stress Scale (Appendix 3):, otherOutcomes measure: Depression-Anxiety-Stress Scale (Appendix 4), otherOutcomes measure: Collection and study of salivary cortisol samples, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Saglık Bilimleri Universitesi, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False