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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversitas Jenderal Soedirman

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with consciousness disorders

Patients with neurological disorders

Patients with cognitive disorders

Patients with more than 3 spinal attempts

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    To serve as a control group no intervention

Treatment groups

33 Participants
are divided into 3 treatment groups
Group A: Arm 1: Murottal TherapyExperimental treatment 1 intervention
Group B: Arm 2: Classical Music TherapyExperimental treatment 1 intervention
Group C: Arm 3: Standard CareExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)
2

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)

Time frame
Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)

Secondary outcomes

Other outcomes

Sponsors and contacts

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