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Clinical Trials/NCT06467747
NCT06467747
Recruiting
N/A

The Efficacy of Intraoperative Music Stimulation on Perioperative Pain Management

Taichung Tzu Chi Hospital1 site in 1 country90 target enrollmentJuly 3, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Perioperative Pain Management
Sponsor
Taichung Tzu Chi Hospital
Enrollment
90
Locations
1
Primary Endpoint
Numeric Rating Scale (NRS)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 3, 2024
End Date
May 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Taichung Tzu Chi Hospital
Responsible Party
Principal Investigator
Principal Investigator

Sih-hua Chen

Attending Physician, Department of Anesthesiology

Taichung Tzu Chi Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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.)
  • 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.)
  • Post-operative nausea and vomiting (PONV)(1. While in the post-anesthesia care unit, for an average of 1 hour.)

Study Sites (1)

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