Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04819750

Enrollment

350

Registered

2021-03-29

Start date

2021-04-30

Completion date

2021-12-31

Last updated

2021-03-29

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

Conditions

Anxiety, Cataract

Brief summary

Cataract surgery with topic anesthesia is anxiety provoking. This operative stress can increase pain perception and blood pressure. This discomfort can lead to non-compliance with immobility and potentially lead to intraoperative and postoperative complications. Pharmacological means are limited to reduce anxiety. Only anxiolytics could be effective but at the cost of side effects not compatible with surgery. Music Care is a digital treatment allowing the diffusion of music with a U-shaped sequence using the principles of hypnoanalgesia. The objective of this study is to evaluate the effectiveness of the MusicCare listening device on the anxiety of patients during cataract surgery with topic anesthesia

Interventions

DEVICEMusicCare® device

The device is a touch tablet with a headset that allows noise reduction. The patient can choose the music they prefer. The selected U-shaped sequence uses the principles of hypnoanalgesia to accompany the patient into a state of deep relaxation.

DEVICEHeadphones with noise reduction

Headphones with noise reduction without music

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Cataract surgery with topical anesthesia

Exclusion criteria

* Hearing impaired patient

Design outcomes

Primary

Measure	Time frame	Description
Self-assessed anxiety score between the 2 groups	Baseline day, when 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)

Secondary

Measure	Time frame	Description
Self-assessment of the duration of the surgery	Baseline day, when entering the operating room	Self-rated duration of surgery on a scale of 0 to 5 (0 means 5 to 10 minutes and 5 means 25 to 30 minutes)

Contacts

Primary ContactBenjamin Javillier, MD

javillier.benjamin@hotmail.com042843820

Outcome results

None listed

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