- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06957990
- Original Trial
Evaluation of Music Therapy for Pre-op/Intra-op During Hernia Surgery to Decrease the Need for Narcotics
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45242
- Bethesda Surgery Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Therapeutics
- Complementary Therapies
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Sensory Art Therapies
- Music Therapy
Other Study ID Numbers
- 24-060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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