The Effect of Quran of Post Operative Pain

NCT02589834 | Completed Phase 2

• 1 other identifier: QPOP
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Measurement of postoperative pain by Visual analogue scale

  4 months

Secondary Outcomes (1)

• The amount of postoperative analgesics by mg

  4 months

Study Arms (2)

Quran group

ACTIVE COMPARATOR

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.

Other: Quran group

Non-Quran group

NO INTERVENTION

Those patients did not listen to Quran and subjected to operative room noise throughout the surgery.

Interventions

Quran group OTHER

Quran group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant Muslim women
• Term (37-40 weeks) gestation
• uncomplicated singleton pregnancy
• scheduled for elective lower segment cesarean section under spinal anesthesia

You may not qualify if:

• Any medical diseases
• Hearing impairment
• Any contraindication to spinal anesthesia

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 28, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

EG (1)