Back to resultsImpact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia
Primary Purpose
Cataract, Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MusicCare® device
Headphones with noise reduction
Sponsored by
About this trial
This is an interventional supportive care trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- Cataract surgery with topical anesthesia
Exclusion Criteria:
- Hearing impaired patient
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
MusicCare® device
Headphones with noise reduction
Arm Description
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 without music
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04819750
Brief Title
Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia
Official Title
Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MusicCare® device
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Headphones with noise reduction
Arm Type
Placebo Comparator
Arm Description
Headphones with noise reduction without music
Intervention Type
Device
Intervention Name(s)
MusicCare® device
Intervention Description
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
Intervention Name(s)
Headphones with noise reduction
Intervention Description
Headphones with noise reduction without music
Primary Outcome Measure Information:
Title
Self-assessed anxiety score between the 2 groups
Description
Self-assessed anxiety score on a visual analogue scale (VAS) from 0 to 10 (0 means no anxiety and 10 the maximum anxiety)
Time Frame
Baseline day, when entering the operating room
Secondary Outcome Measure Information:
Title
Self-assessment of the duration of the surgery
Description
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)
Time Frame
Baseline day, when entering the operating room
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cataract surgery with topical anesthesia
Exclusion Criteria:
Hearing impaired patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Javillier, MD
Phone
042843820
Ext
+32
Email
javillier.benjamin@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia
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