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Recruiting NCT06713044

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

No phase Interventional Pain Pain, Postoperative Inflammation Orthopedic Surgical Procedures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Murottal Therapy Intervention Name: Murottal (Islamic verse recitation), Classical Music Therapy Intervention Name: Classical Music Listening, Standard Care (in control arm).
Who it may be relevant to
Registry conditions: Pain, Pain, Postoperative, Inflammation, Orthopedic Surgical Procedures. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • 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.
  • 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.
  • Other Standard Care (in control arm)
    To serve as a control group no intervention

Primary outcome measures

  • Pain Intensity Postoperatively [Time frame: Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)]
  • Interleukin-6 (IL-6) Levels Postoperatively [Time frame: Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Patients with consciousness disorders
  • Patients with neurological disorders
  • Patients with cognitive disorders
  • Patients with more than 3 spinal attempts
  • Patients with hearing impairments
  • BMI < 18 and > 39 kg/m²

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Prof. Dr. Margono Soekarjo Hospital — Purwokerto

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.

Identifiers

NCT: NCT06713044 · 420/08774

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗