The Efficacy of Music on Perioperative Pain Management

NCT06467747 | Recruiting

• 1 other identifier: REC113-11
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Pain Management

Keywords

Music therapy

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS)

  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 Outcomes (3)

• 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 Arms (3)

Music group

EXPERIMENTAL

Listen music with earphone

Other: Music

Mute group

PLACEBO COMPARATOR

Keep mute under earphone

Other: Mute

Control group

NO INTERVENTION

As usual anesthesia care without earphones

Interventions

Music OTHER

Music group: wear earphones to listen to music and receive standardized anesthesia protocol

Music group

Mute OTHER

Mute group: wear earphones without music and receive standardized anesthesia protocol

Mute group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Tzu Chi Hospital: lead

Study Sites (1)

Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taichung, Not in USA, 427, Taiwan

RECRUITING

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mei-Ling Shen

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Ling Shen

CONTACT

+886-921126960; a8301058@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Anesthesiology

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 21, 2024
• Study Start: July 3, 2024
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)