SurgeryNCT06957990
Evaluation of Music Therapy for Pre-op/Intra-op During Hernia Surgery to Decrease the Need for Narcotics
A study testing Music in people with Surgery and Pain, Postoperative, run by TriHealth Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Pain, Postoperative
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2024to 8 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Receiving surgery at Bethesda Surgery Center
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Conditions
- Surgery, Pain, Postoperative
- Being tested
- Music
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Music of the participant's selected genre will be played through headphones according to the arm assigned.
| Study group | Role | What they receive |
|---|---|---|
| PreOp Only | Experimental | Patient will listen to music before their surgery in pre-operative area only Receives: Other: Music |
| PreOp and IntraOp | Experimental | Patient will listen to music before and during their surgery Receives: Other: Music |
| IntraOp Only | Experimental | Patient will listen to music during their surgery only Receives: Other: Music |
| No Music | No intervention | Patient will not listen to music during their visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from admission to discharge from PACU, up to 8 hours
Total narcotic administered
Total morphine milligram equivalent (MME) of narcotics administered while in PACU
Measured: from admission to discharge from PACU, up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start8 Aug 2024
- Primary completion8 May 2027 (estimated)
- Study completion8 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957990
- Sponsor's protocol ID
- 24-060
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Music Therapy for Pre-op/Intra-op During Hernia Surgery to Decrease the Need for Narcotics
- ClinicalTrials.gov ID
- NCT06957990
- Acronym / sponsor ID
- 24-060
- Conditions
- Surgery, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 8 May 2027 (estimated)
- Study completion
- 8 Dec 2027 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PreOp Only | Experimental | Other: MusicPatient will listen to music before their surgery in pre-operative area only |
| PreOp and IntraOp | Experimental | Other: MusicPatient will listen to music before and during their surgery |
| IntraOp Only | Experimental | Other: MusicPatient will listen to music during their surgery only |
| No Music | No intervention | –Patient will not listen to music during their visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 years or older
- Receiving surgery at Bethesda Surgery Center
Key exclusion criteria (7 listed)
- Does not speak English
- Unable to consent to involvement in the research study
- Having more than 1 hernia repair performed
- Pregnant
- Deaf
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicMusic of the participant's selected genre will be played through headphones according to the arm assigned. | Other | IntraOp Only, PreOp Only, PreOp and IntraOp |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Surgery and Pain, Postoperative, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highest pain score reported (time frame: from admission to discharge from PACU, up to 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.