The Effect of Music on Pain in Patients Undergoing Ventral Hernia Repair With Mesh: A Double-Blind Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Pain, Acute
- Sponsor
- The Cleveland Clinic
- Enrollment
- 321
- Locations
- 1
- Primary Endpoint
- Post operative Pain
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Ajita Prabhu, MD
Staff Physician
The Cleveland Clinic
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
Outcomes
Primary Outcomes
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 Outcomes
- Post operative Anxiety(At 24 hours (+- 3 hours) after surgery end time.)