MUSICATOP: Music Listening for Cataract Surgery

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT02892825
• Collaborator: (none)
• Enrollment: 313
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.7
• Patients Per Site Per Month: 17.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Surgery	Other: Music; Other: No Music	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 313 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Impact of Music on Hypertension During Cataract Surgery Performed Under Topical Anaesthesia
• Actual Study Start Date: Feb 2, 2017
• Actual Primary Completion Date: Jul 25, 2018
• Actual Study Completion Date: Jul 27, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: music group music listening	Other: Music; headphones with music
Active Comparator: no music group no music listening	Other: No Music; headphones without music

Outcome Measures

Primary Outcome Measures

1. Hypertensive event [Intraoperative every 5 minutes]

   Non invasive measure through blood pressure cuff

Secondary Outcome Measures

1. Anxiety score before surgery [before surgery]

   on a visual analogue scale

2. Anxiety score after surgery [after surgery]

   on a visual analogue scale

3. Duration of surgery [after surgery]

4. Intraoperative surgical complications [during surgery]

   reported by surgeon

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cochin Hospital	Paris		France	75014

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Manon Guisse, nurse, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT02892825
• Other Study ID Numbers: K150903; 2016-A00728-43
• First Posted: Sep 8, 2016
• Last Update Posted: Feb 10, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Music; cataract surgery; topical anaesthesia; anxiety; hypertension
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Feb 10, 2020