NCT02892825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
313

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2018

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

July 19, 2016

Last Update Submit

November 17, 2025

Conditions

Keywords

Musiccataract surgerytopical anaesthesiaanxietyhypertension

Outcome Measures

Primary Outcomes (1)

  • Hypertensive event

    Non invasive measure through blood pressure cuff

    Intraoperative every 5 minutes

Secondary Outcomes (4)

  • Anxiety score before surgery

    before surgery

  • Anxiety score after surgery

    after surgery

  • Duration of surgery

    after surgery

  • Intraoperative surgical complications

    during surgery

Study Arms (2)

music group

EXPERIMENTAL

music listening

Other: Music

no music group

ACTIVE COMPARATOR

no music listening

Other: No Music

Interventions

MusicOTHER

headphones with music

music group

headphones without music

no music group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective cataract surgery performed under topical anaesthesia

You may not qualify if:

  • Non topical anaesthesia
  • Non ambulatory surgery
  • Communication difficulties including language barrier, and mental disorders
  • Age\<18yo
  • Hearing impairment
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, Paris, 75014, France

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Anxiety DisordersHypertension

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental DisordersVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Manon Guisse, nurse

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

September 8, 2016

Study Start

February 2, 2017

Primary Completion

July 25, 2018

Study Completion

July 27, 2018

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations