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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2022
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ergonomic chinrest
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.
Ergonomic chinrest used with a low Super Kun shoulder rest
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.

Locations

Country Name City State
Denmark University of Southern Denmark Odense

Sponsors (4)

Lead Sponsor Collaborator
University of Southern Denmark Axel Muusfeldts fond, Region of Southern Denmark, Sygekassernes Helsefond

Country where clinical trial is conducted

Denmark, 

Outcome

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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