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

Study Overview
=================
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

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

Conditions
-----------------
Cataract, Anxiety

Intervention / Treatment
-----------------
* Device: MusicCare® device
* Device: Headphones with noise reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cataract surgery with topical anesthesia Exclusion Criteria: Hearing impaired patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MusicCare® device<br>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. | Device: MusicCare® device<br>* 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.<br>|
| Placebo Comparator: Headphones with noise reduction<br>Headphones with noise reduction without music | Device: Headphones with noise reduction<br>* Headphones with noise reduction without music<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-assessment of the duration of the surgery | 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) | Baseline day, when entering the operating room |