Surgical PerformanceNCT02349204
The Effect of Music on Surgical Skill in the Setting of Simulated Intraocular Surgery
A study testing Music - Mozart's sonata for 2 pianos in D-440 in people with Surgical Performance, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
Music is commonly heard in operating room. The goal of this study is to measure the effect of music on surgical performance using a intraocular surgery simulator. The music chosen is Sonata for 2 pianos D-440 from Mozart. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Performance
- What is being tested?
- Music - Mozart's sonata for 2 pianos in D-440
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Apr 2017
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ophthalmology residents at Laval University
- Ophthalmologist at Centre Hospitalier Universitaire de Québec
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Universitaire d'Ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Québec, G1S 4L8
About this study
Music is commonly heard in operating room. The goal of this study is to measure the effect of music on surgical performance using a intraocular surgery simulator. The music chosen is Sonata for 2 pianos D-440 from Mozart. The participants will complete 2 tasks on the simulator, both with and without music, in a randomized sequence. The results will be subtracted from the simulator and analyzed.
- Conditions
- Surgical Performance
- Being tested
- Music - Mozart's sonata for 2 pianos in D-440
- Keywords
- Simulator, Music, Mozart Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music - Mozart's sonata for 2 pianos in D-440Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Exposure to music | Experimental | The participants in this groups will have to complete the tasks on the intraocular surgery simulator while listening to Mozart's sonata for 2 pianos in D-440 Receives: Behavioral: Music - Mozart's sonata for 2 pianos in D-440 |
| No exposure | No intervention | The participants in this groups will have to complete the tasks on the intraocular surgery simulator in silence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task score
The participants will perform tasks on a simulator on three separate days. The outcome will be measured at each of these visits.
Measured: Assessed up to 12 weeks after randomization
Secondary outcomes (1)
Time to complete the task
The participants will perform tasks on a simulator on three separate days. The outcome will be measured at each of these visits.
Measured: Assessed up to 12 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical PerformanceStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu Caissie, MD, FRCPC, Principal investigator, Centre de recherche du CHU de Québec : Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349204
- Sponsor's protocol ID
- 2015-1938
- Status last verified
- Jul 2017
- First submitted
- 5 Jan 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Surgical Skill in the Setting of Simulated Intraocular Surgery
- ClinicalTrials.gov ID
- NCT02349204
- Acronym / sponsor ID
- 2015-1938
- Conditions
- Surgical Performance
- Keywords
- Simulator, Music, Mozart Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 28 Jan 2015 (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.
Music is commonly heard in operating room. The goal of this study is to measure the effect of music on surgical performance using a intraocular surgery simulator. The music chosen is Sonata for 2 pianos D-440 from Mozart. The participants will complete 2 tasks on the simulator, both with and without music, in a randomized sequence. The results will be subtracted from the simulator and analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure to music | Experimental | Behavioral: Music - Mozart's sonata for 2 pianos in D-440The participants in this groups will have to complete the tasks on the intraocular surgery simulator while listening to Mozart's sonata for 2 pianos in D-440 |
| No exposure | No intervention | –The participants in this groups will have to complete the tasks on the intraocular surgery simulator in silence |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ophthalmology residents at Laval University
- Ophthalmologist at Centre Hospitalier Universitaire de Québec
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Music - Mozart's sonata for 2 pianos in D-440 | Behavioural | Exposure to music |
Primary outcome
Task score
Time frame: Assessed up to 12 weeks after randomization
The participants will perform tasks on a simulator on three separate days. The outcome will be measured at each of these visits.
1 secondary outcome
Time to complete the task
Time frame: Assessed up to 12 weeks after randomization
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 21 Jul 2017.
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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.
Mathieu Caissie, MD, FRCPC principal investigator
Centre de recherche du CHU de Québec : Université Laval
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 - Mozart's sonata for 2 pianos in D-440 in people with Surgical Performance, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 2 inclusion and 1 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 21 Jul 2017. 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 Canada. 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?
Task score (time frame: Assessed up to 12 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2017.