The Efficacy of Music on Perioperative Pain Management

Not Applicable

Recruiting

• Conditions: Perioperative Pain Management
• Interventions: Other: Music; Other: Mute

• Registration Number: NCT06467747
• Lead Sponsor: Taichung Tzu Chi Hospital

Brief Summary

The goal of this clinical trial is to learn if intraoperative music stimulation works to alleviate perioperative pain in surgical patients undergoing general anesthesia. It will also learn about the possible mechanisms by how music affects pain.

The main questions it aims to answer are:

Does music lower the number of times participants need to use a rescue analgesic? What changes occur in electroencephalogram (EEG) and nociception monitors when participants listen to music? Researchers will compare music to mute or control (hear ambient sounds without earphones) to see if music works to alleviate perioperative pain.

Participants will listen music or mute or ambient sounds throughout the operation, and receive routine anesthesia care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-15
• Study First Posted: 2024-06-21
• Study Start: 2024-07-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-02
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Older than 20 years old and younger than 80 years old
• male or female
• Scheduled for minimally invasive surgery (laparoscopic cholecystectomy, appendectomy)
• Ambulatory surgery
• American Society of Anesthesiologists (ASA) physical status I~III

Exclusion Criteria

• Severe hearing impairment
• Severe pulmonary or cardiovascular disease
• Brain or central nervous system (CNS) disorder
• Long-term systemic steroid or daily morphine treatment
• Pregnant women
• Emergency surgery
• The absence of informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music group	Music	Listen music with earphone
Mute group	Mute	Keep mute under earphone

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS)	1. While in the post-anesthesia care unit, for an average of 1 hour. 2. 24 hours after surgery.	To assess pain severity using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Higher scores indicate greater pain intensity.

Secondary Outcome Measures

Name	Time	Method
Analgesic-frequency	1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery.	Frequency of analgesic usage
Analgesic-total amount	1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery.	Total amount of analgesic used
Post-operative nausea and vomiting (PONV)	1. While in the post-anesthesia care unit, for an average of 1 hour.	Frequency of nausea and vomiting episodes

Trial Locations

Locations (1)

Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation; 🇨🇳 Taichung, Not In USA, Taiwan