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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03622190
Other study ID # REP 0177
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2018
Est. completion date March 2020

Study information

Verified date August 2018
Source Queen Margaret University
Contact Cinzia Cruder, MA
Phone 0041766938039
Email Ccruder@qmu.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observational cohort study involves repeated cross-sectional observations in order to identify those factors associated with increased risk of PRMDs among music students.

All pre-college and university-level students from several European music academies will receive an invitation to complete a web-based questionnaire survey at each of three occasions (baseline; 6-months follow-up; 12-months follow-up).


Description:

Professional musicians are exposed to chronic high volume of continuous and repeated physical movements, sometimes in challenging and ergonomically unfavourable anatomical body positions, in order to acquire and improve technical playing skills. As a consequence, musicians are vulnerable to developing adverse playing-related musculoskeletal disorders (PRMDs) that may affect the manner in which and the extent to which music can be practised and performed.

In order to find out effective solutions for PRMDs and to develop future preventive measures, it is fundamental to firstly identify the main risk factors that play a significant role in the development of adverse musculoskeletal (MSK) conditions and symptoms.

The longitudinal cohort study will be conducted through the following three phases:

1. a baseline cross-sectional survey (i.e. web-based questionnaire) to characterise the study population and subgroups, and form the basis for the evaluation of associated factors and relationships with the development of PRMDs;

2. a 6-months follow-up survey, and

3. a 12-months follow-up survey.

After the first baseline data collection (Phase 1), the cohort of students will be broken down into:

- Cohort 1: music students (both pre-college and university-level) who are free of pain and PRMDs at baseline data collection

- Cohort 2: music students (both pre-college and university-level) who aren't free of pain and PRMDs at baseline data collection

Afterwards, the two cohorts will be followed and invited for reassessment at 6 months (Phase 2) and 12 months (Phase 3).

Both the follow-ups will permit longitudinal change in outcome scores to be generated and compared (longitudinal comparisons) for strength and progression of association, alongside those from absolute outcome scores at several cross-sectional analyses.

The web-based survey will include questions about any pain, PRMD and/or MSK problem they may have due to their musical practice, and different outcome measures (i.e. lifestyle and physical activity, practice habits, behaviour toward prevention and health history, level of stress, perfectionism, fatigue and disability).

The outcome measures have been selected according to the relevant findings of previous cross-sectional studies and systematic reviews among the performing arts literature.

Each outcome measure correspond to a suspected factor that may be associated with the development of a PRMD.

To the best of our knowledge, no other longitudinal studies on risk factors for PRMDs have been conducted so far. Therefore, the study can be considered as an opportunity to fill the gaps of current research on PRMDs and generate new knowledge in educational and employment musical contexts.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date March 2020
Est. primary completion date November 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- All pre-college and university-level students from music academies, with a classical instrument as main subject.

Exclusion Criteria:

- Music students without a classical instrument as main subject (composers and conductors)

- Positive history for neurological, rheumatic, psychological disorders or emotional distress, as well as surgery of the upper limbs and/or the spine in the last 12 months.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Queen Margaret University

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of pain or musculoskeletal (MSK) disorder The presence of pain and/or MSK problems will be assessed through the following question: "When did you last experience a bout of significant pain and/or musculoskeletal problem?" up to 12 months
Primary Presence of playing-related musculoskeletal disorders (PRMDs) Self reported PRMDs according to the definition: "any pain and/or musculoskeletal problem interfered with students' ability to play their musical instrument at the level to which they are accustomed" one month
Primary Severity of pain or MSK disorder Respondents are asked to assign a number, from zero (no pain) to ten (the worst possible pain), to the severity of their pain. one month
Primary Location of pain Respondents are asked to indicate where they have pain and/or MSK disorders by clicking on the part(s) in which they have or have had their pain and/or MSK problem during the last month. one month
Primary Pain Disability Index A short, self-report instrument for measuring the degree of interference with normal role functioning caused by pain. The respondent uses an 11-point scale ranging from 0 (no disability) to 10 (total disability) to rate the degree to which pain interferes with functioning in the following seven areas: family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life-support activity. The total score can range from 0 to 70.to participate in essential life activities. one month
Primary A 2-item short form of the Pain Self-efficacy Questionnaire (PSEQ-2) Respondents are asked to rate how confidently they can perform work and normal life activities, despite their pain. They answer by circling a number on a 7-point Likert scale under each item, where 0 = not at all confident and 6= completely confident in the last month. one month
Primary Quick Dash - Performing Arts Section This questions relate to the impact of your pain on playing students' practice. Respondents rate each item based on their experience over the preceding week on a 5-point Likert-type scale, increasing from 1 to 5 in level of difficulty/severity. one week
Primary Self-rated health (SRH) The SHR is a simple measure which is usually assessed as a single-item: "In general, would you say your health is", with the response items "excellent," "very good," "good," "fair," or "poor" to assess health status. 12 months
Secondary Standardised Nordic Questionnaire (SNQ) A general questionnaire on 12-months prevalence of troubles in nine symptom sites being neck, shoulders, upper back, elbows, low back, wrist/hands, hips/thighs, knees and ankles/feet. 12 months
Secondary Internation Physical Activity Questionnaire - short form (IPAQ-SF) IPAQ-SF investigates the physical activity of four intensity levels (i.e. vigorous-intensity activity, moderate-intensity activity, walking, and sitting) in the past week. one week
Secondary Kessler Psychological Distress Scale (K10) A brief measure of non-specific psychological distress in the anxiety-depression spectrum. The K10 comprises ten questions about psychological distress designed to measure anxiety and depression. Each question is related to a specific emotional state and each has a five-level response scale. It is designed to quantify the frequency and severity of anxiety- and depression-related symptoms experienced in the past four weeks. four weeks
Secondary Multidimensional Perfectionism Scale - short form (HFMPS-SF) The HFMPS-SF is a 15-item questionnaire to measure trait perfectionism. Respondents rate each item on a 7-point Likert scale, increasing in level of agreement (from 1 "disagree" to 7 "agree"). Items are structured according to three subscales: self-oriented (SOP), other-oriented (OOP), and socially prescribed perfectionism (SPP), where higher scores on each scale, indicating higher levels of perfectionistic attitudes and behaviours. 12 months
Secondary The Chalder Fatigue Scale (CFQ-11) The CFQ-11 is a reliable measure (Cronbach a = 0.90) to assess the severity of tiredness among population (Chalder et al. 1993). Each of the eleven items are answered on a 4-point Likert-type, from 1 (asymptomatic) increasing to 4 as responses become more symptomatic. The respondent's global score can range from 0 to 33, where higher scores indicate greater tiredness. The global score also includes two dimensions—physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11). one month
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