Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia

NCT ID: NCT04819750

Last Updated: 2021-03-29

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2021-12-31

Brief Summary

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Cataract surgery with topic anesthesia is anxiety provoking. This operative stress can increase pain perception and blood pressure. This discomfort can lead to non-compliance with immobility and potentially lead to intraoperative and postoperative complications.

Pharmacological means are limited to reduce anxiety. Only anxiolytics could be effective but at the cost of side effects not compatible with surgery.

Music Care is a "digital treatment" allowing the diffusion of music with a U-shaped sequence using the principles of hypnoanalgesia.

The objective of this study is to evaluate the effectiveness of the MusicCare listening device on the anxiety of patients during cataract surgery with topic anesthesia

Detailed Description

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Conditions

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Cataract Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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MusicCare® device

The device is a touch tablet with a headset that allows noise reduction. The patient can choose the music they prefer. The selected U-shaped sequence uses the principles of hypnoanalgesia to accompany the patient into a state of deep relaxation.

Group Type ACTIVE_COMPARATOR

MusicCare® device

Intervention Type DEVICE

The device is a touch tablet with a headset that allows noise reduction. The patient can choose the music they prefer. The selected U-shaped sequence uses the principles of hypnoanalgesia to accompany the patient into a state of deep relaxation.

Headphones with noise reduction

Headphones with noise reduction without music

Group Type PLACEBO_COMPARATOR

Headphones with noise reduction

Intervention Type DEVICE

Headphones with noise reduction without music

Interventions

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MusicCare® device

The device is a touch tablet with a headset that allows noise reduction. The patient can choose the music they prefer. The selected U-shaped sequence uses the principles of hypnoanalgesia to accompany the patient into a state of deep relaxation.

Intervention Type DEVICE

Headphones with noise reduction

Headphones with noise reduction without music

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Cataract surgery with topical anesthesia

Exclusion Criteria

* Hearing impaired patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Javillier

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Benjamin Javillier, MD

Role: CONTACT

042843820 ext. +32

Other Identifiers

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MUSICOTOPICAT

Identifier Type: -

Identifier Source: org_study_id

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