Postoperative PainPhase 2NCT02589834
The Effect of Quran of Post Operative Pain
A Phase 2 study testing Quran group in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Quran group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2015to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant Muslim women
- Term (37-40 weeks) gestation
- uncomplicated singleton pregnancy
- scheduled for elective lower segment cesarean section under spinal anesthesia
Who cannot join
- Any medical diseases
- Hearing impairment
- Any contraindication to spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Listening to Quran During Cesarean Section on Postoperative Pain
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.
Read more
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
- Being tested
- Quran group
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quran groupOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quran group |
| Non-Quran group | No intervention | Those patients did not listen to Quran and subjected to operative room noise throughout the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of postoperative pain by Visual analogue scale
Measured: 4 months
Secondary outcomes (1)
The amount of postoperative analgesics by mg
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589834
- Sponsor's protocol ID
- QPOP
- Status last verified
- Oct 2015
- First submitted
- 27 Oct 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to Quran During Cesarean Section on Postoperative Pain
- ClinicalTrials.gov ID
- NCT02589834
- Acronym / sponsor ID
- QPOP
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quran group | Active comparator | Other: Quran groupThe 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. |
| Non-Quran group | No intervention | –Those patients did not listen to Quran and subjected to operative room noise throughout the surgery. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant Muslim women
- Term (37-40 weeks) gestation
- uncomplicated singleton pregnancy
- scheduled for elective lower segment cesarean section under spinal anesthesia
Key exclusion criteria (3 listed)
- Any medical diseases
- Hearing impairment
- Any contraindication to spinal anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quran group | Other | Quran group |
Primary outcome
Measurement of postoperative pain by Visual analogue scale
Time frame: 4 months
1 secondary outcome
The amount of postoperative analgesics by mg
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quran group in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of postoperative pain by Visual analogue scale (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.