The Efficacy of Music on Perioperative Pain Management

June 15, 2024 updated by: Sih-hua Chen, Taichung Tzu Chi Hospital

The Efficacy of Intraoperative Music Stimulation on Perioperative Pain Management

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Not In USA
      • Taichung, Not In USA, Taiwan, 427
        • Recruiting
        • Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music group
Listen music with earphone
Other: Music
Music group: wear earphones to listen to music and receive standardized anesthesia protocol
Placebo Comparator: Mute group
Keep mute under earphone
Other: Mute
Mute group: wear earphones without music and receive standardized anesthesia protocol
No Intervention: Control group
As usual anesthesia care without earphones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS)
Time Frame: 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.
1. While in the post-anesthesia care unit, for an average of 1 hour. 2. 24 hours after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic-frequency
Time Frame: 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
1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery.
Analgesic-total amount
Time Frame: 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
1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery.
Post-operative nausea and vomiting (PONV)
Time Frame: 1. While in the post-anesthesia care unit, for an average of 1 hour.
Frequency of nausea and vomiting episodes
1. While in the post-anesthesia care unit, for an average of 1 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Tzu Chi Hospital

Investigators

  • Principal Investigator: Mei-Ling Shen, Taichung Tzu Chi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 15, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 15, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REC113-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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