NCT07033793

Brief Summary

Student musicians are particularly vulnerable to both physical and psychological health issues, with studies showing that 38% report pain from musical practice and over 50% experience high stress. Despite these risks, health resources tailored specifically to student musicians remain limited. This study aims to address this gap by testing a preventive, digital intervention to improve the well-being of this population. The intervention, delivered via a smartphone or tablet app, is designed to accommodate the unique demands of student musicians, such as frequent travel and time constraints. It includes health education, self-assessment tools, preventive health behavior advice, and interactive games designed to promote healthier work habits, daily routines, and overall health knowledge.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

June 4, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

June 4, 2025

Last Update Submit

July 1, 2025

Conditions

Keywords

PreventionStudent musiciansDigital toolHealth knowledge

Outcome Measures

Primary Outcomes (5)

  • Participant Interest in the App-Based Intervention

    As part of the feasibility assessment guided by the CONSORT extension for pilot and feasibility trials, this outcome evaluates the attractiveness of the application-based intervention, measured by the number of participants who will express interest in the intervention at baseline.

    At baseline.

  • Participant Engagement with and Frequency of Use of the App - Based Intervention

    This outcome measures the use of the app-based intervention as part of the feasibility assessment. Use is evaluated by tracking the frequency of mobile app access by each participant throughout the intervention period.

    From the start of the intervention to 12 weeks.

  • Participant Satisfaction with the App-Based Intervention

    Participant satisfaction is measured using a Visual Analog Scale (VAS), where participants rate their overall satisfaction from 0 (not satisfied) to 10 (fully satisfied).

    6 and 12 weeks after the start of intervention.

  • System Usability of the App-Based Intervention Using SUS

    This outcome assesses the usability of the mobile app-based intervention using the System Usability Scale (SUS), which is a validated 10-item questionnaire designed to evaluate perceived ease of use. The total SUS score ranges from 0 to 100, with higher scores indicating better perceived usability. This measure is part of the feasibility assessment guided by the CONSORT extension for pilot and feasibility trials.

    6 and 12 weeks after the start of intervention.

  • Participant Satisfaction with the App-Based Intervention

    As part of the feasibility assessment guided by the CONSORT extension for pilot and feasibility trials, this outcome evaluates participant satisfaction with the mobile app using the Visual Analog Scale (VAS): satisfaction scores at 6 and 12 weeks, where participants rate overall satisfaction from 0 (not satisfied) to 10 (fully satisfied).

    6 and 12 weeks after the start of intervention.

Secondary Outcomes (11)

  • Assessment of the prevalence of Playing-related Muscoskeletal Disorders by using the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians (MPIIQM).

    Baseline, 6 weeks, 12 weeks after start of intervention

  • Change in Health-Related Quality of Life as Measured by the SF-36 Health Survey

    Baseline, 6 weeks, 12 weeks after start of intervention

  • Change in Psychosocial Adaptation Scores on the Health Interview for Musicians (HIL) Scale

    Baseline, 6 weeks, 12 weeks after start of intervention

  • Change in Psychological Distress Scores on the Kessler Psychological Distress Scale (K10)

    Baseline, 6 weeks, 12 weeks after start of intervention

  • Change in Music Performance Anxiety Scores on the Kenny Music Performance Anxiety Inventory (K-MPAI-R)

    Baseline, 6 weeks, 12 weeks after start of intervention

  • +6 more secondary outcomes

Other Outcomes (1)

  • Demographic Information at Baseline

    Baseline (pre-intervention)

Study Arms (3)

GC

NO INTERVENTION

Control group with no intervention.

GApp

EXPERIMENTAL

Preventive advice with digital support

Behavioral: GApp

GappE

EXPERIMENTAL

Preventive advice with digital support + 5 educational sessions

Behavioral: GappE

Interventions

GAppBEHAVIORAL

Participants receive only digital support with health information, self-assessment tests, preventive advices and games. No educational sessions are provided, and the focus is solely on digital preventive advice used autonomously.

GApp
GappEBEHAVIORAL

Participants receive preventive interventon delivered via digital support (smartphone app) including health information, self-assessment tests, preventive advices and games). In addition to the App used autonomously, they will participate in 5 group educational sessions proposed by a physiotherapist (once every two weeks).

GappE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: Over 18 years old
  • Enrollment at the Geneva University of Music (HEM) as a Bachelor (1st, 2nd, or 3rd year) or Master (1st or 2nd year) student.
  • Primary discipline: Must be in musical performance (instrumental or vocal).
  • Physical ability to play an instrument or sing (no physical disabilities that prevent participation in musical practice).
  • Must be able to follow academic activities as planned.

You may not qualify if:

  • Unable to play their instrument or participate in singing.
  • Underwent surgery in the past 12 months that affects their ability to practice music (e.g., musculoskeletal surgeries).
  • Suffering from pain or medical conditions that are not related to musical practice (e.g., non-musical injuries or pathologies).
  • Unable to follow the planned academic schedule (e.g., missing classes or major academic constraints that would prevent full participation in the study).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva School of Health (HEdS-Geneva)

Geneva, 1227, Switzerland

Location

Related Publications (1)

  • Bruyneel AV, Stern F, Schmid A, Rieben N, James CE. Network analyses of physical and psychological factors of playing-related musculoskeletal disorders in student musicians: a cross-sectional study. BMC Musculoskelet Disord. 2024 Nov 30;25(1):979. doi: 10.1186/s12891-024-08103-8.

    PMID: 39616356BACKGROUND

Central Study Contacts

Anne-Violette Bruyneel, Associate Professor

CONTACT

Clara James, Full Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded, Single
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Number of Arms: 3 * Preventive advice with digital support + educational sessions (GAppE) * Preventive advice with digital support only (GApp) * Control group with no intervention (GC)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 24, 2025

Study Start

September 1, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

July 4, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures may be provided to qualified researchers. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data requests can be submitted starting 9 months after the study completion and after the major publications have been submitted
Access Criteria
At the end of the project, the data will be deposited in repository developed by the University of Geneva. This choice will ensure that data is archived and shared in accordance with FAIR principles.

Locations