Cataract SurgeryMUSICATOPNCT02892825
Music Listening for Cataract Surgery
A study testing Music and No Music in people with Cataract Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Music and No Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2017to 27 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective cataract surgery performed under topical anaesthesia
Who cannot join
- Non topical anaesthesia
- Non ambulatory surgery
- Communication difficulties including language barrier, and mental disorders
- Age<18yo
- Hearing impairment
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Music on Hypertension During Cataract Surgery Performed Under Topical Anaesthesia
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.
Read the 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.
- Conditions
- Cataract Surgery
- Being tested
- Music, No Music
- Keywords
- Music, cataract surgery, topical anaesthesia, anxiety, hypertension
- Medical subject headings
- Anxiety Disorders, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
headphones with music
No MusicOther
headphones without music
| Study group | Role | What they receive |
|---|---|---|
| music group | Experimental | music listening Receives: Other: Music |
| no music group | Active comparator | no music listening Receives: Other: No Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertensive event
Non invasive measure through blood pressure cuff
Measured: Intraoperative every 5 minutes
Secondary outcomes (4)
Anxiety score before surgery
on a visual analogue scale
Measured: before surgery
Anxiety score after surgery
on a visual analogue scale
Measured: after surgery
Duration of surgery
Measured: after surgery
Intraoperative surgical complications
reported by surgeon
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start2 Feb 2017
- Primary completion25 Jul 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Manon Guisse, nurse, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892825
- Sponsor's protocol ID
- K150903
- Other IDs
- 2016-A00728-43
- Acronym
- MUSICATOP
- Status last verified
- Nov 2025
- First submitted
- 19 Jul 2016
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34658886Guerrier 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.
PubMed 34323929
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Music on Hypertension During Cataract Surgery Performed Under Topical Anaesthesia
- ClinicalTrials.gov ID
- NCT02892825
- Acronym / sponsor ID
- MUSICATOP / K150903
- Conditions
- Cataract Surgery
- Keywords
- Music, cataract surgery, topical anaesthesia, anxiety, hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music group | Experimental | Other: Musicmusic listening |
| no music group | Active comparator | Other: No Musicno music listening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective cataract surgery performed under topical anaesthesia
Key exclusion criteria (6 listed)
- Non topical anaesthesia
- Non ambulatory surgery
- Communication difficulties including language barrier, and mental disorders
- Age<18yo
- Hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musicheadphones with music | Other | music group |
| No Musicheadphones without music | Other | no music group |
Primary outcome
Hypertensive event
Time frame: Intraoperative every 5 minutes
Non invasive measure through blood pressure cuff
4 secondary outcomes
Anxiety score before surgery
Time frame: before surgery
Anxiety score after surgery
Time frame: after surgery
Duration of surgery
Time frame: after surgery
Intraoperative surgical complications
Time frame: during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publication: PubMed 34658886Guerrier 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.
- Derived from this study: PubMed 34323929Guerrier 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.
- Individual participant dataSharing planned: No
Related trials for Cataract Surgery
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manon Guisse, nurse principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and No Music in people with Cataract Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertensive event (time frame: Intraoperative every 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02892825, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.