The Effect of Quran of Post Operative Pain
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Quran group
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Pregnant Muslim women
- Term (37-40 weeks) gestation
- uncomplicated singleton pregnancy
- scheduled for elective lower segment cesarean section under spinal anesthesia
Exclusion Criteria:
- Any medical diseases
- Hearing impairment
- Any contraindication to spinal anesthesia
Sites / Locations
- Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Quran group
Non-Quran group
Arm Description
The patients listened to Quran recitation by a compact disc player through an occlusive headphone, started after induction of spinal anesthesia and continued throughout the entire cesarean section duration.
Those patients did not listen to Quran and subjected to operative room noise throughout the surgery.
Outcomes
Primary Outcome Measures
Measurement of postoperative pain by Visual analogue scale
Secondary Outcome Measures
The amount of postoperative analgesics by mg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02589834
Brief Title
The Effect of Quran of Post Operative Pain
Official Title
The Effect of Listening to Quran During Cesarean Section on Postoperative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Postoperative pain management is crucial for surgical patients. Management of postoperative pain entails reducing painful symptoms, improving the quality of recovery and resuming normal daily living activities. In addition to the benefits derived from relieving postoperative pain in women undergoing cesarean section, prolonged immobility as a result of pain during puerperium is associated with risk of thromboembolic disease.
Postoperative pain has negative physiological and psychological impact on patients' well-beings and delays the postoperative recovery. Pain may also impair the mother's ability to provide an optimal care for her infant in the immediate postpartum period. Besides that, it also reduces the maternal ability to breast-feed her infant effectively.
Effective pain relief should not interfere with the mother's ability to move around and care for her infant, and that it results in no adverse neonatal effects in breast-feeding women.
Non-pharmacological techniques for reduction of pain are growing rapidly. Spiritual intervention with listening to Quran recitations as an adjunctive therapy in the postoperative period is a non-pharmacological technique that is inexpensive, non-invasive and has no side-effects. Spiritual and Islamic implication could improve postoperative pain 6-8 hours and 24-30 hours in Muslim patients undergoing abdominal surgery. However, there is limited number of published studies on the effect of spiritual and religious intervention on pain after cesarean section.
Listening to Quran recitation elicits a relaxation response of calmness, mindfulness, and peacefulness in Muslims. Pray therapy results in optimal harmonization, which improves psychological, social, spiritual, and physical health status.
The current study aims to investigate the effects of listening to Quran recitation on pain intensity among patients after cesarean section according to the cultural, social and economic differences in Egypt.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quran group
Arm Type
Active Comparator
Arm Description
The patients listened to Quran recitation by a compact disc player through an occlusive headphone, started after induction of spinal anesthesia and continued throughout the entire cesarean section duration.
Arm Title
Non-Quran group
Arm Type
No Intervention
Arm Description
Those patients did not listen to Quran and subjected to operative room noise throughout the surgery.
Intervention Type
Other
Intervention Name(s)
Quran group
Primary Outcome Measure Information:
Title
Measurement of postoperative pain by Visual analogue scale
Time Frame
4 months
Secondary Outcome Measure Information:
Title
The amount of postoperative analgesics by mg
Time Frame
4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant Muslim women
Term (37-40 weeks) gestation
uncomplicated singleton pregnancy
scheduled for elective lower segment cesarean section under spinal anesthesia
Exclusion Criteria:
Any medical diseases
Hearing impairment
Any contraindication to spinal anesthesia
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
The Effect of Quran of Post Operative Pain
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