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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Terminated

Conditions: Anxiety; Cataract Surgery

Treatments: Device: Device with quiet recorded music; Other: Usual management of anxiety; Device: MusicCare® device

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04781231

LRU_2020_7

Details and patient eligibility

About

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

Enrollment: 411 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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411 participants in 3 patient groups

MusicCare® device

Experimental group

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.

Treatment:

Device: MusicCare® device

Device with quiet recorded music

Active Comparator group

Description:

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

Treatment:

Device: Device with quiet recorded music

Usual management of anxiety

Other group

Treatment:

Other: Usual management of anxiety