Music Listening for Cataract Surgery

Cataract Surgery Clinical Trial

— MUSICATOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892825
• Other study ID #: K150903
• Secondary ID: 2016-A00728-43
• Status: Completed
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: July 27, 2018

Study information

• Verified date: February 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: July 27, 2018
• Est. primary completion date: July 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery

Intervention

Other:
• Music
headphones with music
• No Music
headphones without music

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypertensive event	Non invasive measure through blood pressure cuff	Intraoperative every 5 minutes
Secondary	Anxiety score before surgery	on a visual analogue scale	before surgery
Secondary	Anxiety score after surgery	on a visual analogue scale	after surgery
Secondary	Duration of surgery		after surgery
Secondary	Intraoperative surgical complications	reported by surgeon	during surgery