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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04781231
Acronym
MUSICAT
Enrollment
411
Registered
2021-03-04
Start date
2021-06-21
Completion date
2024-01-24
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Cataract Surgery

Keywords

Cataract surgery, Anxiety, MusicCare, Music

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

Interventions

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.

DEVICEDevice with quiet recorded music

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

OTHERUsual management of anxiety

No specific intervention

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

Participant in the group Usual care are unaware of the other groups, in order to avoir the Hawthorne effect.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Self-assessed anxiety score between the 3 groups Descriptionbaseline day, before entering the operating roomSelf-assessed anxiety score on a visual analogue scale (VAS) from 0 to 10 (0 means no anxiety and 10 the maximum anxiety imaginable)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026