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

Not Applicable

Completed

• Conditions: Hernia Abdominal Wall; Surgery; Anxiety; Ventral Hernia; Postoperative Pain, Acute
• Interventions: Other: Placebo; Other: Patient-Chosen Music

• Registration Number: NCT05374096
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-16
• Study Start: 2022-06-13
• Status Verified: 2023-07
• Primary Completion: 2023-07-15
• Study Completion: 2023-07-17
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silence Via Headphones (Control)	Placebo	Headphones will be placed with silence for the duration of the surgical procedure.
Music Via Headphones	Patient-Chosen Music	Headphones will be placed with patient-selected music playing for the duration of the surgical procedure.

Primary Outcome Measures

Name	Time	Method
Post operative Pain	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

Name	Time	Method
Post operative Anxiety	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.

Trial Locations

Locations (1)

Cleveland Clinic Main Campus; 🇺🇸 Cleveland, Ohio, United States