- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05509465
Using an Ergonomic Chinrest With or Without Shoulder Rest During Violin Playing: a Feasibility Study
Usability and Acceptability of an Ergonomic Chinrest With or Without Shoulder Rest During Violin Playing: a Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is testing the feasibility (usability and acceptability) of a two-week familiarization period where violinists usually playing with a shoulder rest had to play their violin with an ergonomic chinrest (EC) with (EC+) and without a shoulder rest (EC-).
Primary outcomes were compliance, adherence, usability and acceptability of the familiarization period.
Prior the familiarization period each violinist received the chinrest (Kréddle) and a shoulder rest (Kun Super rest violin 4/4) and had to follow instructions given through three introduction videos.
The included violinists received a web questionnaire (QA) before and after the familiarization period. This period is unsupervised with the EC (ergonomic chinrest). Every day each violinist should equally divide their total playing time between playing without shoulder rest (EC-) and the other half with the shoulder rest (EC+) with the EC. A diary was answered each day containing different questions in regard to playing hours and usability.
The reporting in this study adheres to the CONSORT 2010 extension for pilot and feasibility trials.
When this study was initiated, we aimed at a sample size of 10-12 as a rule of thumb for a pilot/feasibility study. However, due to the corona pandemic and the many national restrictions including keeping distance, seeing only a few people, getting tested for the virus and staying at home, if possible, this number could not be reached. Even though the study was planned to include more participants the result from this small study is pointing in one direction, which is supported in a previous study as well.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Odense, Denmark, 5230
- University of Southern Denmark
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Writing and speaking Danish or English fluently. Participants had to be trained violinists who could play the protocol classical repertoire and without a permanent employment contract in a Danish symphony orchestra.
Exclusion Criteria:
- Trauma on the upper cervical spine or upper extremities within the previous year, previous or planned shoulder/neck operation, life-threatening health disorders, pacemaker or severe eczema on neck and upper extremities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ergonomic chinrest used with low shoulder rest (EC+)
Participants will play the violin using the ergonomic chinrest with a low Kun Super shoulder rest (EC+) for a two-week period to test its usability and acceptability.
Each day participants have to use half of their playing time with EC+.
|
The novel ergonomic chinrest (Kréddle®, Wyoming, US) is fully adjustable to accommodate each violinist's body type and performance style: regarding height, rotation and tilting.
The low Super Kun shoulder rest has been adjusted to be in the lowest position for all legs attached to the violin before the violinists received it.
All participants was told not to adjust the shoulder rest but adjust the chinrest.
|
Experimental: Ergonomic chinrest used without shoulder rest (EC-)
Participants will play the violin using the ergonomic chinrest without a shoulder rest for a two-week period to test its usability and acceptability.
Each day participants have to use half of their playing time with EC-.
|
The novel ergonomic chinrest (Kréddle®, Wyoming, US) is fully adjustable to accommodate each violinist's body type and performance style: regarding height, rotation and tilting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability
Time Frame: Two weeks
|
Self-reported information about the usability of the EC- and EC+ was obtained by asking questions about perceived performance, comfort, and sound experience, as well as adjustment and confidence level.
Furthermore, if the instructions videos given prior to the familiarization period were usable.
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Two weeks
|
Acceptability
Time Frame: Two weeks
|
Every day each violinist was encouraged to write feedback in the diary about using EC+, EC- and about the intervention.
The descriptions and comments were categorized into comments about using EC-, EC+ or general comments; the response was grouped as positive or negative feedback.
|
Two weeks
|
Adherence
Time Frame: Two weeks
|
Adherence to the protocol was recorded from the self-administrated two-week diary.
The violinist had to answer a small questionnaire and play each day with one of the settings.
Adherence is counted as numbers of days played with the different settings out of the two weeks given.
|
Two weeks
|
Compliance
Time Frame: Two weeks
|
Compliance for playing with EC- and EC+ was reached if the violinist managed to play minimum 25% out of total playing time with each of both settings.
If compliance was <25% it was considered that it would be a problem to use the setting
|
Two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck movement was recorded by the device called ViMove.
Time Frame: Two weeks
|
Neck movement data was collected with ViMove measured in degrees of movement in three anatomical planes.
This was done after the two weeks and the violinists had to play with both EC and their own preferred chinrest (usual).
These data were collected to make a sample size estimation for a planned larger study.
|
Two weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 10.990
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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