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Clinical Trials/NCT06957990
NCT06957990Enrolling By InvitationNot Applicable

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

TriHealth Inc.1 site in 1 country308 target enrollmentStarted: August 8, 2024Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
308
Locations
1
Primary Endpoint
Total narcotic administered

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Masking Description

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

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • Wears hearing aids
  • Currently on medication-assisted treatment for substance use disorder (ex: suboxone or methadone)

Arms & Interventions

PreOp Only

Experimental

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

Intervention: Music (Other)

PreOp and IntraOp

Experimental

Patient will listen to music before and during their surgery

Intervention: Music (Other)

IntraOp Only

Experimental

Patient will listen to music during their surgery only

Intervention: Music (Other)

No Music

No Intervention

Patient will not listen to music during their visit

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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