Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT06300112
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prenatal Yoga on Stress, Quality of Sexual Life and Sleep Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019529', 'term': 'Sexuality'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized-controlled trial with pretest-posttest control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-10', 'studyFirstSubmitDate': '2024-03-02', 'studyFirstSubmitQcDate': '2024-03-02', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sleep patterns', 'timeFrame': '6 weeks', 'description': "Participants' sleep patterns will not be evaluated with a scale. Therefore, it does not have a specific scoring. The sleep patterns of the participants will be evaluated with questions created by the researchers."}], 'primaryOutcomes': [{'measure': 'Perceived stress level', 'timeFrame': '6 weeks', 'description': 'This will be measured using "Perceived Stress Scale". The minimum score that can be obtained from the scale is "0", the maximum score is "32", and as the scale score increases, perceived stress level also increase.'}, {'measure': 'Sexual Quality of Life', 'timeFrame': '6 weeks', 'description': 'This will be measured using "Sexual Quality of Life Questionnaire-Female". The minimum score that can be obtained from the scale is "18", the maximum score is "108". The total score obtained from the scale must be converted to 100. As the scale score increases, perceived stress level also increase.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Midwifery', 'Perceived Stress', 'Sexual Quality of Life', 'Sleep', 'Pregnancy'], 'conditions': ['Stress', 'Sexuality', 'Sleep']}, 'descriptionModule': {'briefSummary': 'The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns.', 'detailedDescription': 'Although pregnancy is a natural process, the change in physiological and psychosocial balance and the differentiation of roles in life require bio-psychosocial adaptation for the pregnant woman and her environment. In addition to strengthening the uterine and perineal muscles and supporting the spine, yoga is effective in dealing with common problems of pregnancy such as poor blood circulation, blood pressure fluctuations, excessive weight gain, fatigue, edema and urinary problems. The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy week between 24 and 34,\n* Able to read and write Turkish,\n* No communication problems,\n* Those who voluntarily agreed to participate in the research\n\nExclusion Criteria:\n\n* Those who have risky pregnancies,\n* Those with diagnosed psychiatric problems,\n* Participating in a different training program (meditation, relaxation, etc.)'}, 'identificationModule': {'nctId': 'NCT06300112', 'briefTitle': 'Prenatal Yoga on Stress, Quality of Sexual Life and Sleep Level', 'organization': {'class': 'OTHER', 'fullName': 'Amasya University'}, 'officialTitle': 'The Effect of Pregnancy Yoga on Perceived Stress, Quality of Sexual Life and Sleep Level', 'orgStudyIdInfo': {'id': 'Amasya Univ_emine.akca'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Yoga', 'interventionNames': ['Behavioral: YOGA']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No Intervention'}], 'interventions': [{'name': 'YOGA', 'type': 'BEHAVIORAL', 'description': 'Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05100', 'city': 'Amasya', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Emine İbici Akça, Ph.D', 'role': 'CONTACT', 'email': 'emine.akca@amasya.edu.tr', 'phone': '03582115005-4723'}], 'facility': 'Amasya University', 'geoPoint': {'lat': 40.65333, 'lon': 35.83306}}], 'centralContacts': [{'name': 'Emine İbici Akça, Ph.D', 'role': 'CONTACT', 'email': 'emine.akca@amasya.edu.tr', 'phone': '03582115005-4723'}], 'overallOfficials': [{'name': 'Emine İbici Akça', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amasya University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amasya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof. Dr. in the Amasya University Midwifery Department', 'investigatorFullName': 'Emine Akca', 'investigatorAffiliation': 'Amasya University'}}}}