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

NCT06713044 | Recruiting DMC FDA Device

• 1 other identifier: 420/08774
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Pain, Postoperative; Inflammation; Orthopedic Surgical Procedures

Keywords

Quranic Recitation; Classical Music Therapy; Pain Management; Inflammation IL 6; Non-Pharmacological Intervention

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (3)

Arm 1: Murottal Therapy

EXPERIMENTAL

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)

Arm 2: Classical Music Therapy

EXPERIMENTAL

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

Arm 3: Standard Care

EXPERIMENTAL

Participants in this group will receive standard postoperative care following their surgery, without any additional interventions.

Other: Standard Care (in control arm)

Interventions

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.

Arm 1: Murottal Therapy

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.

Arm 2: Classical Music Therapy

Standard Care (in control arm) OTHER

To serve as a control group no intervention

Arm 3: Standard Care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Jenderal Soedirman: lead

Study Sites (1)

Prof. Dr. Margono Soekarjo Hospital

Purwokerto, Central Java, 53146, Indonesia

RECRUITING

Related Publications (1)

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

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Pain; Pain, Postoperative; Inflammation; Agnosia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Guruh Perkasa, Doctor

CONTACT

+6285245883215; perkasaguruh90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: This is a randomized, controlled trial with a parallel assignment study design. Participants will be randomly allocated to one of three groups: Murottal Group: Participants will listen to selected Islamic recitations (murottal) as a therapeutic intervention during their postoperative recovery. Classical Music Group: Participants will listen to selected classical music pieces to evaluate its impact on postoperative pain and inflammation. Standard Care Group: Participants will receive standard postoperative care without any additional therapeutic interventions. The goal is to assess and compare the effectiveness of murottal and classical music in reducing postoperative pain intensity and inflammation (measured by interleukin 6 levels), compared to the standard care. Randomization ensures unbiased distribution among the groups, and the parallel design enables simultaneous assessment of the interventions' effects in different groups.

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 3, 2024
• Study Start: September 1, 2024
• Primary Completion: January 30, 2025
• Study Completion: March 30, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)