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OpenTrials
Completed

NCT Number: NCT02892825

Music Listening for Cataract Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochin Hospital

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Other

headphones with music

no music

Other

headphones without music

Primary outcomes

  1. Hypertensive event

    Time frame: Intraoperative every 5 minutes

    Non invasive measure through blood pressure cuff

Secondary outcomes

  1. Anxiety score before surgery

    Time frame: before surgery

    on a visual analogue scale

  2. Anxiety score after surgery

    Time frame: after surgery

    on a visual analogue scale

  3. Duration of surgery

    Time frame: after surgery

  4. Intraoperative surgical complications

    Time frame: during surgery

    reported by surgeon

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: MUSICATOP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 8, 2016
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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