- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07354334
Effect of Listening to Surah Al-Inshirah (The Opening-Up of the Heart) After Cesarean Birth on Postpartum Outcomes
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
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.
In 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Spiritual 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.
This 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.
Women 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.
Data 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.
This 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selçuklu
-
Konya, Selçuklu, Turkey (Türkiye), 42130
- Selcuk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being literate
- Able to speak and understand Turkish
- Aged 18 years or older
- Primiparous women
- Having undergone cesarean birth
- Gestational age at birth between 37 and 42 weeks
- Identifying as Muslim
- Willing to participate voluntarily after providing written informed consent
- Women who have given birth within the last 48 hours and are hospitalized during the early postpartum period
Exclusion Criteria:
- Having a diagnosed psychiatric disorder
- Newborn admitted to the neonatal intensive care unit
- Experiencing stillbirth
- Having a hearing impairment
Criteria for Withdrawal From the Study
- Development of obstetric complications for any reason during the study
- Requesting to withdraw from the study during the data collection process
- Reporting feeling unwell or uncomfortable during the data collection process
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Surah Al-Inshirah Listening Group
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.
|
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.
|
|
No Intervention: Control
Participants in this group will receive routine postpartum care only, without any additional audio or spiritual intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum Depression Level
Time Frame: Within the first 48 hours postpartum
|
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.
|
Within the first 48 hours postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spiritual Well-Being
Time Frame: Within the first 48 hours postpartum
|
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.
|
Within the first 48 hours postpartum
|
|
Maternal Attachment
Time Frame: Within the first 48 hours postpartum
|
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.
|
Within the first 48 hours postpartum
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22051998
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Depression
-
Women and Infants Hospital of Rhode IslandNot yet recruitingPostpartum Anxiety | Paternal Postpartum Depression
-
Bekelu Teka WorkuJimma UniversityNot yet recruitingPrenatal Depression | Mental Health Related Quality of Life | Maternal Postpartum Depression | Paternal Postpartum DepressionEthiopia
-
Jordan University of Science and TechnologyActive, not recruitingPostpartum Depression | Postpartum Depression (PPD)Jordan
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
Afyonkarahisar Health Sciences UniversityNot yet recruitingPostpartum Depression | Postpartum Anxiety
-
University Hospital, ToulouseCompletedPostnatal Depression | Postpartum Depression (PPD)France
Clinical Trials on Listening to Surah Al-Inshirah
-
Hasan Kalyoncu UniversityCompletedHemodialysis PatientsTurkey
-
Seher TanrıverdiCompletedPatients of Laparoscopic CholecystectomyTurkey
-
Universitas Muhammadiyah SurakartaNot yet recruitingHemodialysis | End-Stage Renal Disease | Chronic Kidney Disease Stage VIndonesia
-
Cliniques universitaires Saint-Luc- Université...Completed
-
University of California, IrvineActive, not recruiting
-
Markus KlimekErasmus University RotterdamCompletedPain | AnalgesiaNetherlands
-
Erasmus Medical CenterCompleted
-
University of Southern CaliforniaCompletedAnxiety | Agitated DepressionUnited States
-
Eye & ENT Hospital of Fudan UniversityUnknown
-
Necmettin Erbakan UniversityCompleted