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

Study 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.

Official Title
-----------------
The Effect of Music on Pain in Patients Undergoing Ventral Hernia Repair With Mesh: A Double-Blind Randomized Controlled Trial

Conditions
-----------------
Postoperative Pain, Acute, Ventral Hernia, Hernia Abdominal Wall, Surgery, Anxiety

Intervention / Treatment
-----------------
* Other: Patient-Chosen Music
* Other: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Via Headphones<br>Headphones will be placed with patient-selected music playing for the duration of the surgical procedure. | Other: Patient-Chosen Music<br>* Music played into headphones.<br>|
| Placebo Comparator: Silence Via Headphones (Control)<br>Headphones will be placed with silence for the duration of the surgical procedure. | Other: Placebo<br>* Silence into headphones.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | At 24 hours (+- 3 hours) after surgery end time. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 24 hours (+- 3 hours) after surgery end time. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Music