Ergonomics Clinical Trial
Official title:
Usability and Acceptability of an Ergonomic Chinrest With or Without Shoulder Rest During Violin Playing: a Feasibility Study
NCT number | NCT05509465 |
Other study ID # | 10.990 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 21, 2020 |
Est. completion date | October 16, 2020 |
Verified date | August 2022 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A one-arm feasibility study was conducted to test if violinists would accept to play with an identified ergonomic chinrest (EC) with the brand name Kréddle every day for two weeks. Every day the participants had to divide their total playing time equally between EC+ (ergonomic chinrest with shoulder rest) and EC- (ergonomic chinrest without shoulder rest) each day.
Status | Completed |
Enrollment | 6 |
Est. completion date | October 16, 2020 |
Est. primary completion date | October 16, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | University of Southern Denmark | Odense |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark | Axel Muusfeldts fond, Region of Southern Denmark, Sygekassernes Helsefond |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Usability | 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. | Two weeks | |
Primary | Acceptability | 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 | |
Primary | Adherence | 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 | |
Primary | Compliance | 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 | Neck movement was recorded by the device called ViMove. | 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 |
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