Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia
1 other identifier
interventional
350
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2021
CompletedFirst Posted
Study publicly available on registry
March 29, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMarch 29, 2021
March 1, 2021
6 months
March 24, 2021
March 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Self-assessment of the duration of the surgery
Baseline day, when entering the operating room
Study Arms (2)
MusicCare® device
ACTIVE COMPARATORThe 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
PLACEBO COMPARATORHeadphones with noise reduction without music
Interventions
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
Eligibility Criteria
You may qualify if:
- Cataract surgery with topical anesthesia
You may not qualify if:
- Hearing impaired patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 24, 2021
First Posted
March 29, 2021
Study Start
April 1, 2021
Primary Completion
October 1, 2021
Study Completion
December 1, 2021
Last Updated
March 29, 2021
Record last verified: 2021-03