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

NCT ID: NCT06957990

Last Updated: 2025-05-06

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

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-08

Study Completion Date

2026-10-08

Brief Summary

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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.

Detailed Description

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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

Conditions

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Surgery Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Preoperative music will be unmasked. Intraoperative music will be masked - Only research nurse will know if music was turned on or off intraoperatively.

Study Groups

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PreOp Only

Patient will listen to music before their surgery in pre-operative area only

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Music of the participant's selected genre will be played through headphones according to the arm assigned.

PreOp and IntraOp

Patient will listen to music before and during their surgery

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Music of the participant's selected genre will be played through headphones according to the arm assigned.

IntraOp Only

Patient will listen to music during their surgery only

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Music of the participant's selected genre will be played through headphones according to the arm assigned.

No Music

Patient will not listen to music during their visit

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music

Music of the participant's selected genre will be played through headphones according to the arm assigned.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bethesda Surgery Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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24-060

Identifier Type: -

Identifier Source: org_study_id

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