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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Inflammation; Pain, Postoperative; Orthopedic Surgical Procedures
• Intervention / Treatment: Device: Murottal Therapy Intervention Name: Murottal (Islamic verse recitation); Device: Classical Music Therapy Intervention Name: Classical Music Listening; Other: Standard Care (in control arm)

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 Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guruh Perkasa, Doctor; Phone Number: +6285245883215; Email: perkasaguruh90@gmail.com

Study Locations

• Indonesia
  • Jawa Tengah
    • Purwokerto, Jawa Tengah, Indonesia, 53146
      • Recruiting
      • Prof. Dr. Margono Soekarjo Hospital
      • Contact: Prof. Dr. Margono Soekarjo Hospital Prof. Dr. Margono Soekarjo Hospital; Phone Number: +62281-632708; Email: rsmargono@jatengprov.go.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Murottal Therapy; Arm 1: Murottal Therapy Intervention: Participants in this group will listen to selected recitations of Islamic verses (murottal) as a non-pharmacological intervention during their postoperative recovery.	Device: Murottal Therapy Intervention Name: Murottal (Islamic verse recitation); To evaluate whether murottal recitations can reduce postoperative pain intensity and lower interleukin 6 levels, which are indicative of inflammation.
Experimental: Arm 2: Classical Music Therapy; Intervention: Participants in this group will listen to selected classical music compositions during their recovery from lower extremity orthopedic surgery with spinal anesthesia.	Device: Classical Music Therapy Intervention Name: Classical Music Listening; To evaluate the impact of classical music on reducing postoperative pain intensity and interleukin 6 levels in the body, thereby managing inflammation.
Experimental: Arm 3: Standard Care; Participants in this group will receive standard postoperative care following their surgery, without any additional interventions.	Other: Standard Care (in control arm); To serve as a control group no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity Postoperatively	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).	Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)
Interleukin-6 (IL-6) Levels Postoperatively	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)	Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)

Collaborators and Investigators

• Sponsor: Universitas Jenderal Soedirman

Publications and helpful links

General Publications

• The Effect of Music Therapy on Pain, Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: A Randomized Controlled Trial Ibrahim Karagoz. et al.

Helpful Links

• The Effect of Perioperative Music on Medication Requirement and Hospital Length of Stay: A Meta-analysis

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: December 1, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: December 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Pain Management; Non-Pharmacological Intervention; Quranic Recitation; Classical Music Therapy; Inflammation IL 6
• Additional Relevant MeSH Terms: Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain; Pain, Postoperative; Inflammation
• Other Study ID Numbers: 420/08774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes