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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Surgery; Ventral Hernia; Postoperative Pain, Acute; Hernia Abdominal Wall
• Intervention / Treatment: Other: Patient-Chosen Music; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 321
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative Pain - 3 days	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")	Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours)
Post operative Pain - cumulative	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")	Will be collected repeatedly by nursing staff per nursing protocol for the first 24 hours after surgery end time.
Post operative Anxiety - 3 days	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.	Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours)
Post operative opioid consumption	Cumulative opioid consumption converted into morphine milligram equivalents.	During the first 72 hours after surgery end time.
Intraoperative sedative use	Total number of intravenous and inhaled anesthetics, benzodiazepines, and opioid medications.	From induction of anesthesia to arrival in the post anesthesia care unit on the day of procedure

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Ajita Prabhu, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): July 17, 2023

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Music
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Pain, Postoperative; Hernia; Acute Pain; Hernia, Ventral
• Other Study ID Numbers: 22-286

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No