Clinical Trials Directory

Trials / Completed

CompletedNCT02892825

Music Listening for Cataract Surgery

Impact of Music on Hypertension During Cataract Surgery Performed Under Topical Anaesthesia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
313 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of the study is to assess the effect of music therapy on anxiety and hypertension during cataract surgery procedures performed under topical anaesthesia.

Detailed description

Cataract surgery is the most frequent surgical procedure performed in Europe, usually done under topical anaesthesia. Restlessness and hypertension are the most frequent medical complications during surgery, potentially leading to surgical complications. Since the surgery is ambulatory and requires the patient's cooperation, heavy intravenous sedation should be avoided. However, this procedure is stressful, with patients experiencing high anxiety due to being awake and aware of the procedure on their eye and equipment. Music therapy may be considered as a non-pharmacologic and non-invasive mean to reduce anxiety and therefore intra-operative hypertension. To assess the effect of music therapy on anxiety and hypertension during cataract surgery procedures under topical anaesthesia, investigators intend to perform a randomized controlled trial. Depending on the results of the study, music therapy may subsequently be replacing the usual premedication before surgery.

Conditions

Interventions

TypeNameDescription
OTHERMusicheadphones with music
OTHERNo Musicheadphones without music

Timeline

Start date
2017-02-02
Primary completion
2018-07-25
Completion
2018-07-27
First posted
2016-09-08
Last updated
2025-11-20

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02892825. Inclusion in this directory is not an endorsement.