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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Prof. Dr. Margono Soekarjo Hospital — Purwokerto

Публикации

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

Идентификаторы

NCT: NCT06713044 · 420/08774

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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