Evaluation of Music Therapy for Pre-op/Intra-op During Hernia Surgery to Decrease the Need for Narcotics

February 12, 2026 updated by: TriHealth Inc.
The purpose of this study is to investigate if audible distraction, in the form of music, before and/or during hernia repair surgery will decrease pain post-operatively.

Study Overview

Status

Enrolling by invitation

Intervention / Treatment

Detailed Description

After performing a thorough review of the literature, no studies were found that examined whether having a patient listen to a genre of music of their choosing before or during surgery impacts their postoperative pain. Music is a way to relax patients and could potentially decrease pain, which is a goal of perioperative services. The current study seeks to fill the gap and examine the impact of music on pain for surgical patients undergoing a hernia repair.

This study will use a randomized, double-blinded, controlled design with four arms:

  • Arm 1: Patient will listen to music before their surgery in pre-operative area only
  • Arm 2: Patient will listen to music before and during their surgery
  • Arm 3: Patient will listen to music during their surgery only
  • Arm 4: Patient will not listen to music during their visit

Study Type

Interventional

Enrollment (Estimated)

308

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 Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Bethesda Surgery Center

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

No

Description

Inclusion Criteria:

  • Aged 18 years or older
  • Receiving surgery at Bethesda Surgery Center

Exclusion Criteria:

  • Does not speak English
  • Unable to consent to involvement in the research study
  • Having more than 1 hernia repair performed
  • Pregnant
  • Deaf
  • Wears hearing aids
  • Currently on medication-assisted treatment for substance use disorder (ex: suboxone or methadone)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PreOp Only
Patient will listen to music before their surgery in pre-operative area only
Music of the participant's selected genre will be played through headphones according to the arm assigned.
Experimental: PreOp and IntraOp
Patient will listen to music before and during their surgery
Music of the participant's selected genre will be played through headphones according to the arm assigned.
Experimental: IntraOp Only
Patient will listen to music during their surgery only
Music of the participant's selected genre will be played through headphones according to the arm assigned.
No Intervention: No Music
Patient will not listen to music during their visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Highest pain score reported
Time Frame: from admission to discharge from PACU, up to 8 hours
Highest pain score reported in the Post Anesthesia Care Unit (PACU); Pain is measured on a 0-10 scale where a higher number corresponds with more pain
from admission to discharge from PACU, up to 8 hours
Total narcotic administered
Time Frame: from admission to discharge from PACU, up to 8 hours
Total morphine milligram equivalent (MME) of narcotics administered while in PACU
from admission to discharge from PACU, up to 8 hours

Collaborators and Investigators

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

Sponsor

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 (Actual)

August 8, 2024

Primary Completion (Estimated)

December 8, 2026

Study Completion (Estimated)

May 8, 2027

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

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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