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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-13

Study Completion Date

2023-07-17

Brief Summary

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

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Detailed Description

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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.

Conditions

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Postoperative Pain, Acute Ventral Hernia Hernia Abdominal Wall Surgery Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Music Via Headphones

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

Group Type EXPERIMENTAL

Patient-Chosen Music

Intervention Type OTHER

Music played into headphones.

Silence Via Headphones (Control)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Silence into headphones.

Interventions

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Patient-Chosen Music

Music played into headphones.

Intervention Type OTHER

Placebo

Silence into headphones.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No