search
Back to results

Music Listening for Cataract Surgery (MUSICATOP)

Primary Purpose

Cataract Surgery

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Music
No Music
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cataract Surgery focused on measuring Music, cataract surgery, topical anaesthesia, anxiety, hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cochin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

music group

no music group

Arm Description

music listening

no music listening

Outcomes

Primary Outcome Measures

Hypertensive event
Non invasive measure through blood pressure cuff

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2016
Last Updated
February 7, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT02892825
Brief Title
Music Listening for Cataract Surgery
Acronym
MUSICATOP
Official Title
Impact of Music on Hypertension During Cataract Surgery Performed Under Topical Anaesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
July 25, 2018 (Actual)
Study Completion Date
July 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery
Keywords
Music, cataract surgery, topical anaesthesia, anxiety, hypertension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
music group
Arm Type
Experimental
Arm Description
music listening
Arm Title
no music group
Arm Type
Active Comparator
Arm Description
no music listening
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
headphones with music
Intervention Type
Other
Intervention Name(s)
No Music
Intervention Description
headphones without music
Primary Outcome Measure Information:
Title
Hypertensive event
Description
Non invasive measure through blood pressure cuff
Time Frame
Intraoperative every 5 minutes
Secondary Outcome Measure Information:
Title
Anxiety score before surgery
Description
on a visual analogue scale
Time Frame
before surgery
Title
Anxiety score after surgery
Description
on a visual analogue scale
Time Frame
after surgery
Title
Duration of surgery
Time Frame
after surgery
Title
Intraoperative surgical complications
Description
reported by surgeon
Time Frame
during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manon Guisse, nurse
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34658886
Citation
Guerrier G, Bernabei F, Lehmann M, Pellegrini M, Giannaccare G, Rothschild PR. Efficacy of Preoperative Music Intervention on Pain and Anxiety in Patients Undergoing Cataract Surgery. Front Pharmacol. 2021 Sep 30;12:748296. doi: 10.3389/fphar.2021.748296. eCollection 2021.
Results Reference
derived
PubMed Identifier
34323929
Citation
Guerrier G, Abdoul H, Jilet L, Rothschild PR, Baillard C. Efficacy of a Web App-Based Music Intervention During Cataract Surgery: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Sep 1;139(9):1007-1013. doi: 10.1001/jamaophthalmol.2021.2767.
Results Reference
derived

Learn more about this trial

Music Listening for Cataract Surgery

We'll reach out to this number within 24 hrs