NCT03622190

Brief 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

July 31, 2018

Last Update Submit

August 4, 2018

Conditions

Keywords

playing-related musculoskeletal disorder (PRMD)music studentspainmusculoskeletal (MSK) disorder

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (5)

  • Standardised Nordic Questionnaire (SNQ)

    12 months

  • Internation Physical Activity Questionnaire - short form (IPAQ-SF)

    one week

  • Kessler Psychological Distress Scale (K10)

    four weeks

  • Multidimensional Perfectionism Scale - short form (HFMPS-SF)

    12 months

  • The Chalder Fatigue Scale (CFQ-11)

    one month

Study Arms (2)

Cohort 1

Music students who are free of pain, PRMDs and/or MSK problems at baseline data collection

Cohort 2

Music students who aren't free of pain, PRMDs and/or MSK problems at baseline data collection

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All pre-college and university-level students from ten music academies, with a classical instrument as main subject (composers and conductors will be excluded) will receive an invitation to complete a web-based questionnaire survey. Pre-college will include third-year and fourth-year students (age: 18 and 19 years old). University-level will include students enrolled in the first, second and third year of the Bachelor degree course (age: between 19, 20 and 22, 23 years old), as well as students enrolled in the first, second and third year of Master degree course (age: between 22, 23 and 35 years old).

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cruder C, Koufaki P, Barbero M, Gleeson N. A longitudinal investigation of the factors associated with increased RISk of playing-related musculoskeletal disorders in MUsic students (RISMUS): a study protocol. BMC Musculoskelet Disord. 2019 Feb 8;20(1):64. doi: 10.1186/s12891-019-2440-4.

MeSH Terms

Conditions

Arm InjuriesPain

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cinzia Cruder, MA

    Queen Margaret University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cinzia Cruder, MA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 9, 2018

Study Start

October 1, 2018

Primary Completion

November 1, 2019

Study Completion

March 1, 2020

Last Updated

August 9, 2018

Record last verified: 2018-08