Clinical trial NCT05509465: Using an Ergonomic Chinrest With or Without Shoulder Rest During Violin Playing: a Feasibility Study
Official title: Usability and Acceptability of an Ergonomic Chinrest With or Without Shoulder Rest During Violin Playing: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ergonomics
Keywords: Feasibility
Violin playing
ergonomic chinrest
performance
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Axel Muusfeldts fond
name: Region of Southern Denmark
name: Sygekassernes Helsefond
First posted: 2022-08-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The two intervention groups (EC+ and EC-) consist of the same participants. Every day the same participants have to divide their violin playing time equally between playing with EC+ and EC-. Each day the order of the interventions is decided by the participants.
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Usability
timeFrame: Two weeks
measure: Acceptability
timeFrame: Two weeks
measure: Adherence
timeFrame: Two weeks
measure: Compliance
timeFrame: Two weeks
Secondary outcomes:
measure: Neck movement was recorded by the device called ViMove.
timeFrame: Two weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Karen Søgaard, PhD
role: PRINCIPAL_INVESTIGATOR
References: