Music Listening for Cataract Surgery

Not Applicable

Completed

• Conditions: Cataract Surgery
• Interventions: Other: Music; Other: No Music

• Registration Number: NCT02892825
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Study Timeline

• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Study Start: 2017-02-02
• Primary Completion: 2018-07-25
• Study Completion: 2018-07-27
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

• Patients undergoing elective cataract surgery performed under topical anaesthesia

Exclusion Criteria

• Non topical anaesthesia
• Non ambulatory surgery
• Communication difficulties including language barrier, and mental disorders
• Age<18yo
• Hearing impairment
• Uncontrolled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
music group	Music	music listening
no music group	No Music	no music listening

Primary Outcome Measures

Name	Time	Method
Hypertensive event	Intraoperative every 5 minutes	Non invasive measure through blood pressure cuff

Secondary Outcome Measures

Name	Time	Method
Anxiety score before surgery	before surgery	on a visual analogue scale
Intraoperative surgical complications	during surgery	reported by surgeon
Anxiety score after surgery	after surgery	on a visual analogue scale
Duration of surgery	after surgery

Trial Locations

Locations (1)

Cochin Hospital; 🇫🇷 Paris, France