Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:21 AM
Study NCT ID:
NCT07354334
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-05
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Listening to Surah Al-Inshirah (The Opening-Up of the Heart) After Cesarean Birth on Postpartum Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study. Due to the nature of the audio-based spiritual intervention, participants and researchers are aware of group assignment.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to either an intervention group receiving routine postpartum care plus listening to Surah Al-Inshirah or a control group receiving routine postpartum care only.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 172}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postpartum Depression Level', 'timeFrame': 'Within the first 48 hours postpartum', 'description': 'Postpartum depression will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), a validated self-report questionnaire measuring depressive symptoms in the postpartum period. Higher scores indicate higher levels of depressive symptoms. The EPDS is a validated 10-item self-report questionnaire assessing depressive symptoms in the postpartum period. Each item is scored on a 4-point scale (0-3). Total scores range from 0 to 30, with higher scores indicating more severe depressive symptoms.'}], 'secondaryOutcomes': [{'measure': 'Spiritual Well-Being', 'timeFrame': 'Within the first 48 hours postpartum', 'description': "Spiritual well-being will be measured using the Spirituality Index of Well-Being (SIWB), which assesses individuals' perceived spiritual quality of life and sense of meaning and peace. The SIWB assesses perceived spiritual quality of life and sense of meaning and peace. The scale contains 12 items scored on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Total scores range from 12 to 60, with higher scores indicating greater spiritual well-being."}, {'measure': 'Maternal Attachment', 'timeFrame': 'Within the first 48 hours postpartum', 'description': 'Maternal attachment will be evaluated using the Maternal Attachment Scale, which measures the emotional bond between mother and infant. The Maternal Attachment Scale evaluates the emotional bond between mother and infant. The scale consists of 18 items scored on a 4-point Likert scale (1 = almost never, 4 = almost always). Total scores range from 18 to 72, with higher scores indicating stronger maternal attachment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Depression', 'Maternal-Fetal Relations', 'Spirituality']}, 'descriptionModule': {'briefSummary': "This randomized controlled trial aims to evaluate the effect of listening to the recitation of Surah Al-Inshirah during the early postpartum period after cesarean birth on women's spiritual well-being, depression levels, and maternal attachment. The postpartum period is a sensitive phase characterized by physical recovery, emotional changes, and adaptation to the maternal role, particularly following cesarean delivery. Spiritual and religious practices are commonly used as coping strategies in this period, especially in Muslim populations.\n\nIn this study, women who have undergone cesarean birth will be randomly assigned to either an intervention group or a control group. The intervention group will listen to the recitation of Surah Al-Inshirah in addition to receiving routine postpartum care, while the control group will receive routine postpartum care only. Outcomes related to spiritual well-being, postpartum depression, and maternal attachment will be assessed within the first 48 hours after birth. The findings of this study are expected to contribute to evidence-based, culturally sensitive, and low-cost supportive care practices in the early postpartum period.", 'detailedDescription': "The postpartum period is a critical transition phase in which women experience significant physiological, psychological, and emotional changes. Women who give birth by cesarean section may face additional challenges such as postoperative pain, limited mobility, delayed recovery, and increased vulnerability to emotional distress. These factors may negatively affect spiritual well-being, increase the risk of postpartum depression, and interfere with the development of maternal attachment.\n\nSpiritual care interventions have gained increasing attention as supportive approaches in maternal health, particularly in cultures where religious beliefs and practices play an important role in coping with stress and emotional difficulties. In Islamic tradition, listening to the recitation of the Qur'an is believed to promote inner peace, emotional comfort, and spiritual strength. Surah Al-Inshirah, which emphasizes relief after hardship and emotional ease, may be especially meaningful during the early postpartum period.\n\nThis study is designed as a randomized controlled trial and will be conducted in the postpartum wards of a tertiary hospital. The study population will consist of primiparous women aged 18 years and older who have undergone cesarean birth and meet the inclusion criteria. Participants will be randomly assigned to either the intervention group or the control group using a randomization procedure conducted by an independent healthcare professional to minimize allocation bias.\n\nWomen in the intervention group will receive routine postpartum care and will additionally listen to a standardized audio recording of Surah Al-Inshirah during the first 48 hours after birth. The recitation will be delivered in a calm and comfortable environment at a safe sound level, with multiple listening sessions scheduled during the early postpartum period. Women in the control group will receive routine postpartum care only, without any additional audio or spiritual intervention.\n\nData will be collected using a personal information form and validated measurement tools, including the Spirituality Index of Well-Being, the Edinburgh Postpartum Depression Scale, and the Maternal Attachment Scale. Measurements will be conducted at baseline and repeated approximately 48 hours after birth to assess changes in outcomes. Statistical analyses will be performed to compare outcomes between the intervention and control groups.\n\nThis study aims to provide scientific evidence regarding the effectiveness of a culturally appropriate, low-cost, and non-invasive spiritual intervention to support women's psychological and emotional well-being after cesarean birth. The results may inform holistic and culturally sensitive postpartum care practices in maternal and newborn health services."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being literate\n* Able to speak and understand Turkish\n* Aged 18 years or older\n* Primiparous women\n* Having undergone cesarean birth\n* Gestational age at birth between 37 and 42 weeks\n* Identifying as Muslim\n* Willing to participate voluntarily after providing written informed consent\n* Women who have given birth within the last 48 hours and are hospitalized during the early postpartum period\n\nExclusion Criteria:\n\n* Having a diagnosed psychiatric disorder\n* Newborn admitted to the neonatal intensive care unit\n* Experiencing stillbirth\n* Having a hearing impairment\n\nCriteria for Withdrawal From the Study\n\n* Development of obstetric complications for any reason during the study\n* Requesting to withdraw from the study during the data collection process\n* Reporting feeling unwell or uncomfortable during the data collection process'}, 'identificationModule': {'nctId': 'NCT07354334', 'briefTitle': 'Effect of Listening to Surah Al-Inshirah (The Opening-Up of the Heart) After Cesarean Birth on Postpartum Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': "The Effect of Listening to Surah Al-Inshirah (The Opening-Up of the Heart) in the Early Postpartum Period After Cesarean Birth on Women's Spiritual Well-Being, Depression, and Maternal Attachment: A Randomized Controlled Trial", 'orgStudyIdInfo': {'id': '22051998'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Surah Al-Inshirah Listening Group', 'description': 'Participants in this group will receive routine postpartum care and will additionally listen to an audio recording of Surah Al-Inshirah during the early postpartum period following cesarean birth.', 'interventionNames': ['Behavioral: Listening to Surah Al-Inshirah']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in this group will receive routine postpartum care only, without any additional audio or spiritual intervention.'}], 'interventions': [{'name': 'Listening to Surah Al-Inshirah', 'type': 'BEHAVIORAL', 'description': 'Participants will listen to a standardized audio recording of Surah Al-Inshirah in a quiet and comfortable environment during the first 48 hours after cesarean birth, in addition to routine postpartum care.', 'armGroupLabels': ['Experimental: Surah Al-Inshirah Listening Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42130', 'city': 'Konya', 'state': 'Selçuklu', 'country': 'Turkey (Türkiye)', 'facility': 'Selçuk University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Dr.', 'investigatorFullName': 'Yasemin ERKAL AKSOY', 'investigatorAffiliation': 'Selcuk University'}}}}