Clinical trial NCT06713044: Effect of Quranic Recitation and Classical Music on Pain Intensity and Interleukin-6 Levels After Lower Limb Orthopedic Surgery with Intrathecal Anesthesia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Pain, Postoperative
Inflammation
Orthopedic Surgical Procedures
Keywords: Quranic Recitation
Classical Music Therapy
Pain Management
Inflammation IL 6
Non-Pharmacological Intervention
Lead sponsor: Universitas Jenderal Soedirman
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity Postoperatively
timeFrame: Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)
measure: Interleukin-6 (IL-6) Levels Postoperatively
timeFrame: Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Purwokerto
country: Indonesia
facility: Prof. Dr. Margono Soekarjo Hospital
state: Jawa Tengah
Study officials:
References:
citation: The Effect of Music Therapy on Pain, Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: A Randomized Controlled Trial Ibrahim Karagoz. et al.