Effect of Quranic Recitation and Classical Music on Pain Intensity and Interleukin-6 Levels After Lower Limb Orthopedic Surgery with Intrathecal Anesthesia

Not Applicable

Recruiting

• Conditions: Pain; Pain, Postoperative; Inflammation; Orthopedic Surgical Procedures

• Registration Number: NCT06713044
• Lead Sponsor: Universitas Jenderal Soedirman

Brief Summary

The goal of this study is to determine the effect of murottal and classical music on postoperative pain intensity and interleukin 6 levels in patients undergoing lower extremity orthopedic surgery with spinal anesthesia. This study also aims to evaluate whether these therapies can help reduce pain and influence the body's inflammatory response.

Main questions to be answered:

Can murottal or classical music reduce postoperative pain intensity in patients? Can the use of murottal or classical music lower the levels of interleukin 6, an inflammatory marker, in patients after lower extremity orthopedic surgery?

Participants will:

Listen to murottal or classical music during their lower extremity orthopedic surgery with spinal anesthesia.

Measure pain intensity and interleukin 6 levels before and after the intervention to assess the effect of the therapy.

Undergo routine checkups to ensure the safety and success of the therapy. This study aims to provide a deeper understanding of the use of non-pharmacological therapies such as murottal and classical music in managing pain and the inflammatory response in patients after orthopedic surgery.

Detailed Description

This study aims to explore the impact of murottal (recitations of Islamic verses) and classical music on postoperative pain intensity and interleukin 6 levels in patients undergoing lower extremity orthopedic surgery with spinal anesthesia. Murottal and classical music are considered non-pharmacological interventions and have been suggested to have a calming effect that may help reduce pain and manage inflammation.

During the study, participants will be randomly assigned to receive either murottal, classical music, or standard postoperative care. Participants in the murottal group will listen to selected recitations durante operation, while participants in the classical music group will listen to classical music compositions.

Pain intensity will be assessed using a numeric rating scale (NRS) both before and after the intervention. Interleukin 6 levels, an inflammatory marker, will be measured using blood samples taken at the same intervals.

The goal is to determine whether these therapeutic interventions can help reduce pain and inflammation, as indicated by interleukin 6 levels, compared to standard care alone. Regular check-ups will be conducted to monitor safety and ensure the success of the therapy.

The findings of this study will help provide insights into the potential use of non-pharmacological interventions, such as murottal and classical music, in managing pain and inflammation in postoperative patients, with the potential to improve recovery outcomes

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-12-01
• Last Update Submitted: 2024-12-01
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-01-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. All Muslim patients who are scheduled for elective lower extremity orthopedic surgery during the study period.
2. Patients aged 18 to 60 years.
3. Patients who agree to participate in the study.
4. Lower extremity orthopedic surgery (ORIF, OREF, and bone replacement) with a minimum surgery duration of 60 minutes.

Exclusion Criteria

1. Patients with consciousness disorders
2. Patients with neurological disorders
3. Patients with cognitive disorders
4. Patients with more than 3 spinal attempts
5. Patients with hearing impairments
6. BMI < 18 and > 39 kg/m²

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Intensity Postoperatively	Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)	Primary Outcome Measure 1: Pain Intensity Postoperatively Description: This measure will assess the intensity of pain experienced by participants after surgery.; Method of Measurement: Numeric Rating Scale (NRS), where participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
Interleukin-6 (IL-6) Levels Postoperatively	Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)	Primary Outcome Measure 2: Interleukin-6 Levels Postoperatively Description: This measure will evaluate the levels of IL-6, a marker for inflammation, following surgery.; Method of Measurement: Blood sample analysis, expressed in picograms per milliliter (pg/mL)

Trial Locations

Locations (1)

Prof. Dr. Margono Soekarjo Hospital; 🇮🇩 Purwokerto, Jawa Tengah, Indonesia