Study Exploring the Effect of Music on Pain After Ventral Hernia Surgery
Primary Purpose
Postoperative Pain, Acute, Ventral Hernia, Hernia Abdominal Wall
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-Chosen Music
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain, Acute focused on measuring Music
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Cleveland Clinic Main Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Music Via Headphones
Silence Via Headphones (Control)
Arm Description
Headphones will be placed with patient-selected music playing for the duration of the surgical procedure.
Headphones will be placed with silence for the duration of the surgical procedure.
Outcomes
Primary Outcome Measures
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")
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05374096
Brief Title
Study Exploring the Effect of Music on Pain After Ventral Hernia Surgery
Official Title
The Effect of Music on Pain in Patients Undergoing Ventral Hernia Repair With Mesh: A Double-Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
July 17, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Acute, Ventral Hernia, Hernia Abdominal Wall, Surgery, Anxiety
Keywords
Music
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
321 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music Via Headphones
Arm Type
Experimental
Arm Description
Headphones will be placed with patient-selected music playing for the duration of the surgical procedure.
Arm Title
Silence Via Headphones (Control)
Arm Type
Placebo Comparator
Arm Description
Headphones will be placed with silence for the duration of the surgical procedure.
Intervention Type
Other
Intervention Name(s)
Patient-Chosen Music
Intervention Description
Music played into headphones.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Silence into headphones.
Primary Outcome Measure Information:
Title
Post operative Pain
Description
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")
Time Frame
At 24 hours (+- 3 hours) after surgery end time.
Secondary Outcome Measure Information:
Title
Post operative Anxiety
Description
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.
Time Frame
At 24 hours (+- 3 hours) after surgery end time.
Other Pre-specified Outcome Measures:
Title
Post operative Pain - 3 days
Description
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")
Time Frame
Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours)
Title
Post operative Pain - cumulative
Description
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")
Time Frame
Will be collected repeatedly by nursing staff per nursing protocol for the first 24 hours after surgery end time.
Title
Post operative Anxiety - 3 days
Description
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.
Time Frame
Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours)
Title
Post operative opioid consumption
Description
Cumulative opioid consumption converted into morphine milligram equivalents.
Time Frame
During the first 72 hours after surgery end time.
Title
Intraoperative sedative use
Description
Total number of intravenous and inhaled anesthetics, benzodiazepines, and opioid medications.
Time Frame
From induction of anesthesia to arrival in the post anesthesia care unit on the day of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajita Prabhu, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Main Campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
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Study Exploring the Effect of Music on Pain After Ventral Hernia Surgery
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