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

Not Applicable

• Conditions: Surgery; Pain, Postoperative

• Registration Number: NCT06957990
• Lead Sponsor: TriHealth Inc.

Brief Summary

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

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 Timeline

• Study Start: 2024-08-08
• Study First Submitted: 2025-04-21
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Study First Posted: 2025-05-06
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-08-08
• Study Completion: 2026-10-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 308

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total narcotic administered	from admission to discharge from PACU, up to 8 hours	Total morphine milligram equivalent (MME) of narcotics administered while in PACU
Highest pain score reported	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

Trial Locations

Locations (1)

Bethesda Surgery Center; 🇺🇸 Cincinnati, Ohio, United States