Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT07201220
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Meditation in Early Labor: Impact on Self-Efficacy and Childbirth Fear in First-Time Mothers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'After informing the pregnant women about the study and the procedures to be implemented, informed consent will be obtained from those who agree to participate. Following this, participants will complete the data collection form, and pre-test questionnaires will be administered. Subsequently, relaxation meditation will be played via headphones during labor, and the questionnaires will be applied again as post-tests.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-09', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in perceived childbirth self-efficacy measured by the Childbirth Self-Efficacy Inventory Short Form (CBSEI-SF)', 'timeFrame': 'From the beginning of the active phase of the first stage of labor to 1 hour after the intervention', 'description': "Perceived childbirth self-efficacy is assessed using the Childbirth Self-Efficacy Inventory Short Form (CBSEI-SF). The scale is administered during the active phase of the first stage of labor (before the intervention), and re-administered 1 hour after relaxation meditation. Change in scores indicates the effect of the intervention on participants' self-efficacy levels."}], 'secondaryOutcomes': [{'measure': 'Change in fear of childbirth measured by the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ Version A)', 'timeFrame': 'From the beginning of the active phase of the first stage of labor to 1 hour after the intervention', 'description': 'Fear of childbirth is assessed using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ Version A). The scale is applied before the relaxation meditation during the active phase of the first stage of labor and re-applied 1 hour after the intervention. The change in scores reflects the effect of the intervention on fear of childbirth.intervention and re-administered within 24 hours after delivery to evaluate changes in fear levels among participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meditation']}, 'descriptionModule': {'briefSummary': 'Aim-Introduction:\n\nThe feeling of uncertainty about what will happen during labor, and the mother\'s perception of inadequacy regarding childbirth, can lead to anxiety and stress in some pregnant women, resulting in fear of childbirth and avoidance behaviors. This study was conducted to examine whether there are significant differences in childbirth self-efficacy and fear of childbirth between primiparous pregnant women who practiced meditation and those who did not during the first stage of labor.\n\nMaterials and Methods:\n\nThis experimental study is planned to be conducted between 01.04.2025 and 01.08.2025 with a total of 60 pregnant women (30 in the experimental group and 30 in the control group) who applied to the delivery unit of a tertiary hospital in Turkey and were in the first stage of labor. After informing the pregnant women about the study and the procedures to be implemented, written informed consent was obtained from those who agreed to participate. Subsequently, the pre-tests of the relevant scales and the data collection form were administered. The relaxation meditation during childbirth was applied to the experimental group, followed by the post-tests of the same scales.\n\nData were collected using the "Childbirth Self-Efficacy Inventory Short Form" and the "Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) Version A." Descriptive statistics and hypothesis tests will be used for data analysis.', 'detailedDescription': "Introduction:\n\nThis study aims to examine whether there are significant differences in childbirth self-efficacy and fear of childbirth between primiparous pregnant women who practice meditation (experimental group) and those who do not (control group) during the first stage of labor. Childbirth is a physiological process for every woman, but feelings of uncertainty, perceived inadequacy, anxiety, and stress can lead to fear of childbirth and avoidance behavior. Studies show that 6.3-75% of pregnant women experience fear of childbirth, with 6-10% affected severely. This fear can be influenced by biological, psychological, social, and secondary factors such as previous traumatic experiences or negative birth stories. Furthermore, gestational age and parity also play important roles in the emergence of birth fear.\n\nFear of childbirth can result in complications such as prolonged labor, emergency or elective cesarean delivery, postpartum depression, post-traumatic stress disorder, and disruption in mother-infant bonding. Various methods, including cognitive-behavioral techniques, psychoeducation, and relaxation therapies like hypnobirthing, are used to manage this fear. Research suggests that birth fear is not solely linked to pain or information deficits but to many other factors, including a woman's sense of self-efficacy.\n\nSelf-efficacy refers to a person's belief in their ability to complete tasks or overcome challenges. A woman with high self-efficacy is more likely to manage stress-inducing situations, such as labor, by trusting her own capabilities. Increasing self-efficacy and reducing fear of childbirth can be achieved through relaxation techniques, one of which is meditation. Meditation involves mental training that helps individuals find strength and solutions to problems, promoting relaxation that may alleviate both mental and physical tension. During pregnancy and labor, meditation can assist in reducing anxiety and enhancing positive birth experiences.\n\nAim:\n\nThe study aims to investigate whether relaxation through meditation in the first stage of labor can enhance self-efficacy and reduce fear of childbirth in primiparous women, contributing to a less stressful and anxious labor process. Gestational age and parity are known to influence childbirth fear. The research will evaluate whether meditation can help reduce anxiety and foster self-efficacy, aiding in a more manageable birth experience.\n\nResearch Problem:\n\nDoes a significant difference exist between the self-efficacy and fear of childbirth of primiparous women who receive meditation during the first stage of labor and those who do not?\n\nKeywords: Primiparous pregnancy, Meditation, Childbirth Self-Efficacy, Fear of Childbirth."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrimiparous pregnant women\n\nIn the first stage of labor\n\nSingleton pregnancy\n\nAged 18 and above\n\nAble to provide informed consent\n\nNo high-risk pregnancy or psychiatric diagnosis\n\nExclusion Criteria:\n\nMultiparous women\n\nHigh-risk pregnancy\n\nPrevious experience with meditation during labor\n\nCommunication difficulties'}, 'identificationModule': {'nctId': 'NCT07201220', 'briefTitle': 'Meditation in Early Labor: Impact on Self-Efficacy and Childbirth Fear in First-Time Mothers', 'organization': {'class': 'OTHER', 'fullName': 'Seyhan District Health Directorate, Adana'}, 'officialTitle': 'The Effect of Relaxation Meditation During the First Stage of Labor on Childbirth Self-Efficacy and Fear in Primiparous Women: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2022.03.06/123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A Randomized Controlled Experimental Study', 'description': 'Experimental Group:\n\n30 primiparous women in the first stage of labor receive relaxation meditation during labor. Pre- and post-tests using the Childbirth Self-Efficacy Inventory Short Form and W-DEQ Version A are applied. Data collected between 01.04.2025 and 01.08.2025 at a tertiary hospital in Turkey.\n\nControl Group:\n\n30 primiparous women in the first stage of labor receive standard care without intervention. The same pre- and post-tests are applied. Data collected in the same period and setting.', 'interventionNames': ['Behavioral: meditation']}], 'interventions': [{'name': 'meditation', 'type': 'BEHAVIORAL', 'description': 'The study is planned to include 60 pregnant women (30 in the experimental group and 30 in the control group) in the first stage of labor. After informing the participants about the study and obtaining informed consent, pre-test scales will be administered. Relaxation meditation will be applied during labor for the experimental group, followed by post-test scales.', 'armGroupLabels': ['A Randomized Controlled Experimental Study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adana', 'state': 'Adana', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'EMEL SALCAN', 'role': 'CONTACT', 'email': 'emelsalcan01@gmail.com', 'phone': '05061727755'}], 'facility': 'Seyhan İlçe Sağlık Müdürlüğü', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'city': 'Seyhan', 'state': 'Adana', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'EMEL SALCAN', 'role': 'CONTACT', 'email': 'emelsalcan01@gmail.com', 'phone': '05061727755'}], 'facility': 'Seyhan İlçe Sağlık Müdürlüğü', 'geoPoint': {'lat': 36.98747, 'lon': 35.30592}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seyhan District Health Directorate, Adana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD Midwife', 'investigatorFullName': 'EMEL SALCAN', 'investigatorAffiliation': 'Seyhan District Health Directorate, Adana'}}}}