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Impact of Music Added to the Usual Treatment on the Anxiety of Patients Undergoing Outpatient Cataract Surgery With Topical Anesthesia (MUSICAT)

Primary Purpose

Cataract Surgery, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MusicCare® device
Device with quiet recorded music
Usual management of anxiety
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cataract Surgery focused on measuring Cataract surgery, Anxiety, MusicCare, Music

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • First cataract surgery (first eye)
  • Patient scheduled for short outpatient cataract surgery with topical anesthesia

Exclusion Criteria:

  • Pregnant or breastfeeding woman.

Sites / Locations

  • Hôpital Fondation A. de RothschuldRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

MusicCare® device

Device with quiet recorded music

Usual management of anxiety

Arm Description

The device consists of a headset and a touch pad. The patient can choose the style of music he prefers among 5. The 'U-shaped sequence' offered by MusicCare® is based on the principle of hypnoanalgesia. Musical induction is personalized according to the patient's preference. It will gradually lead to a hypnotic state of consciousness modified by variations in musical components such as rhythm, frequencies, orchestral formation and volume. A listening session lasts about 20 minutes.

An mp3 device with headphones will be given to the patient. Caregivers will launch a quiet 20-minute music playlist

Outcomes

Primary Outcome Measures

Self-assessed anxiety score between the 3 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 imaginable)

Secondary Outcome Measures

Full Information

First Posted
March 1, 2021
Last Updated
October 18, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT04781231
Brief Title
Impact of Music Added to the Usual Treatment on the Anxiety of Patients Undergoing Outpatient Cataract Surgery With Topical Anesthesia
Acronym
MUSICAT
Official Title
Impact of Music Added to the Usual Treatment on the Anxiety of Patients Undergoing Outpatient Cataract Surgery With Topical Anesthesia: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Most patients treated for cataract surgery benefit from a short outpatient course with topical local anesthesia. Having to undergo surgery, especially on the eye, without being asleep, can be stressful. Sometimes waiting in a waiting room with other patients can increase this stress. Patient anxiety may increase blood pressure potentially leading to the prescription of nicardipine to allow surgery to be performed. The patient's anxiety also increases the surgeon's stress, which can alter the conditions for performing the intervention and increase the risk of intraoperative complications. Besides the administration of anxiolytics, nurses have few options for patients with anxiety. However, the treatment response time is not always appropriate and the patient's cooperation during the procedure can sometimes be impaired. The effect of music on preoperative anxiety has been evaluated in several studies and has shown a significant decrease in anxiety before surgery. MusicCare® is a "digital treatment" based on the principles of hypnoanalgesia which has been tested in the management of patients with various pathologies (depression, Alzheimer's disease, chronic pain, etc.) and has shown relative effectiveness. the absence of intervention on the pain and anxiety of patients. In the context of cataract surgery with topical local anesthesia, we would like to assess the contribution of offering the MusicCare® listening device on patients' anxiety about absence

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery, Anxiety
Keywords
Cataract surgery, Anxiety, MusicCare, Music

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Participant in the group Usual care are unaware of the other groups, in order to avoir the Hawthorne effect.
Allocation
Randomized
Enrollment
411 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MusicCare® device
Arm Type
Experimental
Arm Description
The device consists of a headset and a touch pad. The patient can choose the style of music he prefers among 5. The 'U-shaped sequence' offered by MusicCare® is based on the principle of hypnoanalgesia. Musical induction is personalized according to the patient's preference. It will gradually lead to a hypnotic state of consciousness modified by variations in musical components such as rhythm, frequencies, orchestral formation and volume. A listening session lasts about 20 minutes.
Arm Title
Device with quiet recorded music
Arm Type
Active Comparator
Arm Description
An mp3 device with headphones will be given to the patient. Caregivers will launch a quiet 20-minute music playlist
Arm Title
Usual management of anxiety
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
MusicCare® device
Intervention Description
The device consists of a headset and a touch pad. The patient can choose the style of music he prefers among 5. The 'U-shaped sequence' offered by MusicCare® is based on the principle of hypnoanalgesia. Musical induction is personalized according to the patient's preference. It will gradually lead to a hypnotic state of consciousness modified by variations in musical components such as rhythm, frequencies, orchestral formation and volume. A listening session lasts about 20 minutes.
Intervention Type
Device
Intervention Name(s)
Device with quiet recorded music
Intervention Description
An mp3 device with headphones will be given to the patient. Caregivers will launch a quiet 20-minute music playlist
Intervention Type
Other
Intervention Name(s)
Usual management of anxiety
Intervention Description
No specific intervention
Primary Outcome Measure Information:
Title
Self-assessed anxiety score between the 3 groups Description
Description
Self-assessed anxiety score on a visual analogue scale (VAS) from 0 to 10 (0 means no anxiety and 10 the maximum anxiety imaginable)
Time Frame
baseline day, before entering the operating room

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First cataract surgery (first eye) Patient scheduled for short outpatient cataract surgery with topical anesthesia Exclusion Criteria: Pregnant or breastfeeding woman.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie YAVCHITZ, MD
Phone
01 48 03 64 54
Ext
+33
Email
ayavchitz@for.paris
First Name & Middle Initial & Last Name or Official Title & Degree
Robin BARRAUD
Email
rbarraud@for.paris
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin BARRAUD
Organizational Affiliation
Hôpital Fondation A. de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Fondation A. de Rothschuld
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin BARRAUD
Email
rbarraud@for.paris
First Name & Middle Initial & Last Name & Degree
Léa ROHOU
Email
lrohou@hopital-dcss.org

12. IPD Sharing Statement

Learn more about this trial

Impact of Music Added to the Usual Treatment on the Anxiety of Patients Undergoing Outpatient Cataract Surgery With Topical Anesthesia

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