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Study Exploring the Effect of Music on Pain After Ventral Hernia Surgery

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ClinicalTrials.gov Identifier: NCT05374096
Recruitment Status : Recruiting
First Posted : May 16, 2022
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
Ajita Prabhu, MD, The Cleveland Clinic

Study Description
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Brief Summary:
The purpose of this study is to assess whether listening to music during surgery has an effect on pain or anxiety after surgery.

Condition or disease Intervention/treatment Phase
Postoperative Pain, Acute Ventral Hernia Hernia Abdominal Wall Surgery Anxiety Other: Patient-Chosen Music Other: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Music on Pain in Patients Undergoing Ventral Hernia Repair With Mesh: A Double-Blind Randomized Controlled Trial
Actual Study Start Date : June 13, 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Hernia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Music Via Headphones
Headphones will be placed with patient-selected music playing for the duration of the surgical procedure.
 Other: Patient-Chosen Music
Music played into headphones.
Placebo Comparator: Silence Via Headphones (Control)
Headphones will be placed with silence for the duration of the surgical procedure.
 Other: Placebo
Silence into headphones.


Outcome Measures
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Primary Outcome Measures :
  1. 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")


Secondary Outcome Measures :
  1. Post operative Anxiety [ Time Frame: At 24 hours (+- 3 hours) after surgery end time. ]
    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.


Other Outcome Measures:
  1. Post operative Pain - 3 days [ Time Frame: Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours) ]
    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")

  2. Post operative Pain - cumulative [ Time Frame: Will be collected repeatedly by nursing staff per nursing protocol for the first 24 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")

  3. Post operative Anxiety - 3 days [ Time Frame: Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours) ]
    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.

  4. Post operative opioid consumption [ Time Frame: During the first 72 hours after surgery end time. ]
    Cumulative opioid consumption converted into morphine milligram equivalents.

  5. Intraoperative sedative use [ Time Frame: From induction of anesthesia to arrival in the post anesthesia care unit on the day of procedure ]
    Total number of intravenous and inhaled anesthetics, benzodiazepines, and opioid medications.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults having open retromuscular ventral hernia repair with mesh, with or without myofascial release for a hernia width ≤ 20 cm
  2. Adults having open flank hernia repair that requires a myofascial release with mesh
  3. Adults having parastomal hernia repair with mesh

Exclusion Criteria:

  1. Primary language other than English, or lack of English language fluency
  2. Hearing impairment, with or without use of hearing aids
  3. Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and anxiety
  4. Patients who will remain intubated after surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05374096


Contacts
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Contact: Ajita Prabhu, MD 216-444-4790 prabhua@ccf.org
Contact: Corey Gentle, MD 2169038922 gentlec@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Main Campus Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ajita Prabhu, MD    216-444-4790    prabhua@ccf.org   
Contact: Corey Gentle    2169038922    gentlec@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Ajita Prabhu, MD The Cleveland Clinic
More Information
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Responsible Party: Ajita Prabhu, MD, Staff Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT05374096    
Other Study ID Numbers: 22-286
First Posted: May 16, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ajita Prabhu, MD, The Cleveland Clinic:
Music
Additional relevant MeSH terms:
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Pain, Postoperative
Hernia
Hernia, Ventral
Acute Pain
Postoperative Complications
 Pathologic Processes
Pain
Neurologic Manifestations
Pathological Conditions, Anatomical
Hernia, Abdominal