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Music Listening for Cataract Surgery (MUSICATOP)

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Cataract Surgery

Treatments

Other: Music
Other: No Music

Study type

Interventional

Funder types

Other

Identifiers

NCT02892825
2016-A00728-43 (Other Identifier)
K150903

Details and patient eligibility

About

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.

Full 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.

Enrollment

313 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

313 participants in 2 patient groups

music group
Experimental group
Description:
music listening
Treatment:
Other: Music
no music group
Active Comparator group
Description:
no music listening
Treatment:
Other: No Music

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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