Postoperative Pain, AcuteNCT05374096
Study Exploring the Effect of Music on Pain After Ventral Hernia Surgery
A study testing Patient-Chosen Music in people with Postoperative Pain, Acute and Ventral Hernia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess whether listening to music during surgery has an effect on pain or anxiety after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Acute, Ventral Hernia, Hernia Abdominal Wall
- What is being tested?
- Patient-Chosen Music
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2022to 17 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults having open retromuscular ventral hernia repair with mesh, with or without myofascial release for a hernia width ≤ 20 cm
- Adults having open flank hernia repair that requires a myofascial release with mesh
- Adults having parastomal hernia repair with mesh
Who cannot join
- Primary language other than English, or lack of English language fluency
- Hearing impairment, with or without use of hearing aids
- Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and anxiety
- Patients who will remain intubated after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music on Pain in Patients Undergoing Ventral Hernia Repair With Mesh: A Double-Blind Randomized Controlled Trial
The purpose of this study is to assess whether listening to music during surgery has an effect on pain or anxiety after surgery.
Read the detailed description
After being informed about the study and potential risks and meeting eligibility criteria, all patients giving written informed consent will be scheduled for their hernia repair surgery. On the day of surgery, patients will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to listen to patient-chosen music during their surgery via headphones or just listen to silence via headphones. Pain and anxiety will then be assessed after surgery.
- Being tested
- Patient-Chosen Music, Placebo
- Keywords
- Music
- Medical subject headings
- Pain, Postoperative, Hernia, Ventral, Hernia, Abdominal, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Chosen MusicOther
Music played into headphones.
PlaceboOther
Silence into headphones.
| Study group | Role | What they receive |
|---|---|---|
| Music Via Headphones | Experimental | Headphones will be placed with patient-selected music playing for the duration of the surgical procedure. Receives: Other: Patient-Chosen Music |
| Silence Via Headphones (Control) | Placebo comparator | Headphones will be placed with silence for the duration of the surgical procedure. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative Pain
Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: At 24 hours (+- 3 hours) after surgery end time.
Secondary outcomes (1)
Post operative Anxiety
Anxiety scores will be assessed using State Trait Anxiety Index-6 (STAI-6) Anxiety tool (a 6 question patient-reported anxiety assessment). The higher the total, the greater the anxiety is.
Measured: At 24 hours (+- 3 hours) after surgery end time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start13 Jun 2022
- Primary completion15 Jul 2023
- Study completion17 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ajita Prabhu, MD, The Cleveland Clinic
- Investigators
- Ajita Prabhu, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374096
- Sponsor's protocol ID
- 22-286
- Status last verified
- Jul 2023
- First submitted
- 2 May 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maskal SM, Gentle CK, Ellis RC, Tu C, Rosen MJ, Petro CC, Miller BT, Beffa LRA, Chang JH, Messer N, Melland-Smith M, Jeekel J, Prabhu AS. Does selective intraoperative music reduce pain following abdominal wall reconstruction? A double-blind randomized controlled trial. Hernia. 2024 Oct;28(5):1831-1841. doi: 10.1007/s10029-024-03092-y. Epub 2024 Jun 18.
PubMed 38890182
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Pain in Patients Undergoing Ventral Hernia Repair With Mesh: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05374096
- Acronym / sponsor ID
- 22-286
- Keywords
- Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 16 May 2022 (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 assess whether listening to music during surgery has an effect on pain or anxiety after surgery.
Detailed description
After being informed about the study and potential risks and meeting eligibility criteria, all patients giving written informed consent will be scheduled for their hernia repair surgery. On the day of surgery, patients will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to listen to patient-chosen music during their surgery via headphones or just listen to silence via headphones. Pain and anxiety will then be assessed after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Via Headphones | Experimental | Other: Patient-Chosen MusicHeadphones will be placed with patient-selected music playing for the duration of the surgical procedure. |
| Silence Via Headphones (Control) | Placebo comparator | Other: PlaceboHeadphones will be placed with silence for the duration of the surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults having open retromuscular ventral hernia repair with mesh, with or without myofascial release for a hernia width ≤ 20 cm
- Adults having open flank hernia repair that requires a myofascial release with mesh
- Adults having parastomal hernia repair with mesh
Key exclusion criteria (4 listed)
- Primary language other than English, or lack of English language fluency
- Hearing impairment, with or without use of hearing aids
- Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and anxiety
- Patients who will remain intubated after surgery
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 |
|---|---|---|
| Patient-Chosen MusicMusic played into headphones. | Other | Music Via Headphones |
| PlaceboSilence into headphones. | Other | Silence Via Headphones (Control) |
Primary outcome
Post operative Pain
Time frame: At 24 hours (+- 3 hours) after surgery end time.
Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
1 secondary outcome
Post operative Anxiety
Time frame: At 24 hours (+- 3 hours) after surgery end time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Derived from this study: PubMed 38890182Maskal SM, Gentle CK, Ellis RC, Tu C, Rosen MJ, Petro CC, Miller BT, Beffa LRA, Chang JH, Messer N, Melland-Smith M, Jeekel J, Prabhu AS. Does selective intraoperative music reduce pain following abdominal wall reconstruction? A double-blind randomized controlled trial. Hernia. 2024 Oct;28(5):1831-1841. doi: 10.1007/s10029-024-03092-y. Epub 2024 Jun 18.
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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. This study is not recruiting at the moment.
Ajita Prabhu, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Chosen Music in people with Postoperative Pain, Acute and Ventral Hernia, run by The Cleveland Clinic 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 21 Jul 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post operative Pain (time frame: At 24 hours (+- 3 hours) after surgery end time.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05374096, which also lists 1 linked publication.
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 21 Jul 2023.