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

NCT04781231 | Terminated

• 1 other identifier: LRU_2020_7
• Study Type: interventional
• Target: 411
• Locations: 1 country
• Sites: 1

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

Conditions

Cataract Surgery; Anxiety

Keywords

Cataract surgery; Anxiety; MusicCare; Music

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

MusicCare® device

EXPERIMENTAL

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

Device with quiet recorded music

ACTIVE COMPARATOR

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

Usual management of anxiety

OTHER

Other: Usual management of anxiety

Interventions

MusicCare® device 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.

MusicCare® device

Device with quiet recorded music DEVICE

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

Device with quiet recorded music

Usual management of anxiety OTHER

No specific intervention

Usual management of anxiety

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or breastfeeding woman.

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation A. de Rothschuld

Paris, 75019, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Robin BARRAUD

  Hôpital Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participant in the group Usual care are unaware of the other groups, in order to avoir the Hawthorne effect.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: June 21, 2021
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)