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NCT Number: NCT06713044

Effect of Quranic Recitation and Classical Music on Pain Intensity and Interleukin-6 Levels After 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.

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Key information

Conditions

Pain Agnosia Inflammation Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthopedic Surgical Procedures Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Dr. Margono Soekarjo Hospital

Purwokerto, Central Java, 53146, Indonesia

Location status: Recruiting

Location contact

Prof. Dr. Margono Soekarjo Hospital Prof. Dr. Margono Soekarjo Hospital

CONTACT

[email protected]

+62281-632708

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Murottal Therapy Intervention Name: Murottal (Islamic verse recitation)

Device

To evaluate whether murottal recitations can reduce postoperative pain intensity and lower interleukin 6 levels, which are indicative of inflammation.

Classical Music Therapy Intervention Name: Classical Music Listening

Device

To evaluate the impact of classical music on reducing postoperative pain intensity and interleukin 6 levels in the body, thereby managing inflammation.

Standard Care (in control arm)

Other

To serve as a control group no intervention

Primary outcomes

  1. Pain Intensity Postoperatively

    Time frame: 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).

  2. Interleukin-6 (IL-6) Levels Postoperatively

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Guruh Perkasa, Doctor

CONTACT

[email protected]

+6285245883215

Sponsors and collaborators

Lead sponsor

Universitas Jenderal Soedirman

Other

Registry information

Official study 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

Acronym: QRCM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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