The Efficacy of Music on Perioperative Pain Management

NCT ID: NCT06467747

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-03

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Perioperative Pain Management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Music group

Listen music with earphone

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

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

Mute group

Keep mute under earphone

Group Type PLACEBO_COMPARATOR

Mute

Intervention Type OTHER

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

Control group

As usual anesthesia care without earphones

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Music

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

Intervention Type OTHER

Mute

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taichung Tzu Chi Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sih-hua Chen

Attending Physician, Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mei-Ling Shen

Role: PRINCIPAL_INVESTIGATOR

Taichung Tzu Chi Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taichung, Not in USA, Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mei-Ling Shen

Role: CONTACT

+886-921126960

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mei-Ling Shen

Role: primary

+886-921126960

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC113-11

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pre-operative Stress Reduction With Music
NCT02870517 ACTIVE_NOT_RECRUITING NA