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

Anxiety Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04781231
• Other study ID #: LRU_2020_7
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amélie YAVCHITZ, MD
• Phone: 01 48 03 64 54
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 411
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• First cataract surgery (first eye)

• Patient scheduled for short outpatient cataract surgery with topical anesthesia

Exclusion Criteria:

• Pregnant or breastfeeding woman.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cataract
• Cataract Surgery

Intervention

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.
• 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
No specific intervention

Locations

Country	Name	City	State
France	Hôpital Fondation A. de Rothschuld	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline day, before entering the operating room