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

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Recruiting
CT.gov ID
NCT04781231
Collaborator
(none)
411
1
3
38.4
10.7

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: MusicCare® device
  • Device: Device with quiet recorded music
  • Other: Usual management of anxiety
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 21, 2021
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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

Other: Usual management of anxiety

Other: Usual management of anxiety
No specific intervention

Outcome Measures

Primary Outcome Measures

  1. Self-assessed anxiety score between the 3 groups Description [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • First cataract surgery (first eye)

  • Patient scheduled for short outpatient cataract surgery with topical anesthesia

Exclusion Criteria:
  • Pregnant or breastfeeding woman.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Fondation A. de Rothschuld Paris France 75019

Sponsors and Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Léa ROHOU, Hôpital Fondation A. de Rothschild

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT04781231
Other Study ID Numbers:
  • LRU_2020_7
First Posted:
Mar 4, 2021
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2022