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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)

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ClinicalTrials.gov Identifier: NCT04781231
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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


Condition or disease Intervention/treatment Phase
Cataract Surgery Anxiety Device: MusicCare® device Device: Device with quiet recorded music Other: Usual management of anxiety Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 411 participants
Allocation: Randomized
Intervention 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.
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 21, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Cataract

Arm Intervention/treatment
Experimental: MusicCare® device
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.
Device: MusicCare® device
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.

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

Usual management of anxiety Other: Usual management of anxiety
No specific intervention




Primary Outcome Measures :
  1. Self-assessed anxiety score between the 3 groups Description [ Time Frame: baseline day, before 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 imaginable)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or breastfeeding woman.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04781231


Contacts
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Contact: Amélie YAVCHITZ, MD 01 48 03 64 54 ext +33 ayavchitz@for.paris
Contact: Léa ROHOU lrohou@for.paris

Locations
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France
Hôpital Fondation A. de Rothschuld Recruiting
Paris, France, 75019
Contact: Léa ROHOU       lrohou@for.paris   
Contact: Romain COURTIN, MD       rcourtin@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Léa ROHOU Hôpital Fondation A. de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04781231    
Other Study ID Numbers: LRU_2020_7
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Cataract surgery
Anxiety
MusicCare
Music
Additional relevant MeSH terms:
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Cataract
Anxiety Disorders
Mental Disorders
Lens Diseases
Eye Diseases