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

Not Applicable

• Conditions: Cataract; Anxiety
• Interventions: Device: Headphones with noise reduction; Device: MusicCare® device

• Registration Number: NCT04819750
• Lead Sponsor: University of Liege

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Last Update Submitted: 2021-03-24
• Study First Posted: 2021-03-29
• Last Update Posted: 2021-03-29
• Study Start: 2021-04
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Cataract surgery with topical anesthesia

Exclusion Criteria

• Hearing impaired patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Headphones with noise reduction	Headphones with noise reduction	Headphones with noise reduction without music
MusicCare® device	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.

Primary Outcome Measures

Name	Time	Method
Self-assessed anxiety score between the 2 groups	Baseline day, when entering the operating room	Self-assessed anxiety score on a visual analogue scale (VAS) from 0 to 10 (0 means no anxiety and 10 the maximum anxiety)

Secondary Outcome Measures

Name	Time	Method
Self-assessment of the duration of the surgery	Baseline day, when entering the operating room	Self-rated duration of surgery on a scale of 0 to 5 (0 means 5 to 10 minutes and 5 means 25 to 30 minutes)