Evaluation of Music Therapy for Pre-op/Intra-op During Hernia Surgery to Decrease the Need for Narcotics
1 other identifier
interventional
308
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable surgery
Started Aug 2024
Typical duration for not_applicable surgery
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2024
CompletedFirst Submitted
Initial submission to the registry
April 21, 2025
CompletedFirst Posted
Study publicly available on registry
May 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 8, 2027
February 17, 2026
February 1, 2026
2.3 years
April 21, 2025
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Highest pain score reported
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
Total morphine milligram equivalent (MME) of narcotics administered while in PACU
from admission to discharge from PACU, up to 8 hours
Study Arms (4)
PreOp Only
EXPERIMENTALPatient will listen to music before their surgery in pre-operative area only
PreOp and IntraOp
EXPERIMENTALPatient will listen to music before and during their surgery
IntraOp Only
EXPERIMENTALPatient will listen to music during their surgery only
No Music
NO INTERVENTIONPatient will not listen to music during their visit
Interventions
Music of the participant's selected genre will be played through headphones according to the arm assigned.
Eligibility Criteria
You may qualify if:
- Aged 18 years or older
- Receiving surgery at Bethesda Surgery Center
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TriHealth Inc.lead
Study Sites (1)
Bethesda Surgery Center
Cincinnati, Ohio, 45242, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Preoperative music will be unmasked. Intraoperative music will be masked - Only research nurse will know if music was turned on or off intraoperatively.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2025
First Posted
May 6, 2025
Study Start
August 8, 2024
Primary Completion (Estimated)
December 8, 2026
Study Completion (Estimated)
May 8, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share