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

NeuroTherapia, Inc.

Status: Completed

Conditions: Postoperative Pain, Acute; Hernia Abdominal Wall; Surgery; Ventral Hernia; Anxiety

Treatments: Other: Placebo; Other: Patient-Chosen Music

Study type: Interventional

Funder types: Other

Identifiers

NCT05374096

22-286

Details and patient eligibility

About

The purpose of this study is to assess whether listening to music during surgery has an effect on pain or anxiety after surgery.

Full 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.

Enrollment: 321 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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321 participants in 2 patient groups, including a placebo group

Music Via Headphones

Experimental group

Description:

Headphones will be placed with patient-selected music playing for the duration of the surgical procedure.

Treatment:

Other: Patient-Chosen Music

Silence Via Headphones (Control)

Placebo Comparator group

Description:

Headphones will be placed with silence for the duration of the surgical procedure.

Treatment:

Other: Placebo