The Effect of Quran of Post Operative Pain

Postoperative Pain Clinical Trial

Official title:

The Effect of Listening to Quran During Cesarean Section on Postoperative Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589834
• Other study ID #: QPOP
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2015
• Last updated: October 27, 2015
• Start date: April 2015
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Quran group

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of postoperative pain by Visual analogue scale		4 months	Yes
Secondary	The amount of postoperative analgesics by mg		4 months	Yes