ErgonomicsNCT05509465
Using an Ergonomic Chinrest With or Without Shoulder Rest During Violin Playing: a Feasibility Study
A study testing Ergonomic chinrest and Ergonomic chinrest used with a low Super Kun shoulder rest in people with Ergonomics, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ergonomics
- What is being tested?
- Ergonomic chinrest and Ergonomic chinrest used with a low Super Kun shoulder rest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Aug 2020to 16 Oct 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usability and Acceptability of an Ergonomic Chinrest With or Without Shoulder Rest During Violin Playing: a Feasibility Study
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.
Read the 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.
- Conditions
- Ergonomics
- Being tested
- Ergonomic chinrest, Ergonomic chinrest used with a low Super Kun shoulder rest
- Keywords
- Feasibility, Violin playing, ergonomic chinrest, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic chinrestDevice
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 restDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Ergonomic chinrest used with low shoulder rest (EC+) | Experimental | 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+. Receives: Device: Ergonomic chinrest used with a low Super Kun shoulder rest |
| Ergonomic chinrest used without shoulder rest (EC-) | Experimental | 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-. Receives: Device: Ergonomic chinrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks
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.
Measured: Two weeks
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.
Measured: Two weeks
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
Measured: Two weeks
Secondary outcomes (1)
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.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start21 Aug 2020
- Primary completion16 Oct 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErgonomicsStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Axel Muusfeldts fond, Region of Southern Denmark, Sygekassernes Helsefond
- Responsible party
- Sponsor
- Investigators
- Karen Søgaard, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509465
- Sponsor's protocol ID
- 10.990
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Acceptability of an Ergonomic Chinrest With or Without Shoulder Rest During Violin Playing: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05509465
- Acronym / sponsor ID
- 10.990
- Conditions
- Ergonomics
- Keywords
- Feasibility, Violin playing, ergonomic chinrest, performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Axel Muusfeldts fond, Region of Southern Denmark, Sygekassernes Helsefond
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 22 Aug 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ergonomic chinrest used with low shoulder rest (EC+) | Experimental | Device: Ergonomic chinrest used with a low Super Kun shoulder restParticipants 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+. |
| Ergonomic chinrest used without shoulder rest (EC-) | Experimental | Device: Ergonomic chinrestParticipants 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-. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Ergonomic chinrestThe novel ergonomic chinrest (Kréddle®, Wyoming, US) is fully adjustable to accommodate each violinist's body type and performance style: regarding height, rotation and tilting. | Device | Ergonomic chinrest used without shoulder rest (EC-) |
| Ergonomic chinrest used with a low Super Kun shoulder restThe 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. | Device | Ergonomic chinrest used with low shoulder rest (EC+) |
Primary outcome
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.
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.
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.
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
1 secondary outcome
Neck movement was recorded by the device called ViMove.
Time frame: Two weeks
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 22 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Karen Søgaard, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergonomic chinrest and Ergonomic chinrest used with a low Super Kun shoulder rest in people with Ergonomics, run by University of Southern Denmark at 1 site in Denmark.
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 1 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 22 Aug 2022. 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 Denmark. 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?
Usability (time frame: Two weeks). The study lists 4 primary outcomes in all. 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 22 Aug 2022.