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临床试验/NCT05509465
NCT05509465已完成不适用

Usability and Acceptability of an Ergonomic Chinrest With or Without Shoulder Rest During Violin Playing: a Feasibility Study

University of Southern Denmark2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
Acceptability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Device Feasibility
盲法
None

盲法说明

This study is open label, meaning that no masking occurs.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Acceptability

时间窗: 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.

Usability

时间窗: 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.

Compliance

时间窗: 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

Adherence

时间窗: 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.

次要结局

  • Neck movement was recorded by the device called ViMove.(Two weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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