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Healthy AdultsHarMoNieNCT07033793

Evaluation of the Effectiveness of Application-Supported Preventive Advice on Student Musicians' Health

A study testing GApp and GappE in people with Healthy Adults, run by Anne-Violette Bruyneel at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Adults
What is being tested?
GApp and GappE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSwitzerland
Study dates
1 Sep 2025to 31 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Geneva School of Health (HEdS-Geneva)

    Geneva, 1227

Other trials in Switzerland

About this study

Official title: Evaluation of a Preventive Intervention for Student Musicians, Independently Achievable, to Improve Good Health Behaviors: A Randomized Controlled Pilot and Feasibility Study.

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.

Read the detailed description

Student musicians are significantly affected by physical and psychological health issues. Previous studies highlighted that 38% of student musicians experience pain related to their musical practice over a 12-month period, and more than 50% report high levels of stress (general and specific to musical performance).

Despite these concerning trends, tailored health resources and advice specific to student musicians remain rare. Improved work habits and daily health behaviors are crucial for primary prevention and could enhance both learning conditions and long-term health despite the high level of musical practice. Digital, evidence-based interventions, tailored to the specific needs of musicians, could offer a practical solution given their unique constraints, which include frequent travel, limited resources, and demanding schedules.

This study aims to evaluate the feasibility and effectiveness of a smartphone/tablet-based preventive intervention for student musicians. The intervention is designed to improve their physical, psychological, and social well-being, as well as health knowledge. Given the health risks associated with pre-professional and professional music practice, these issues impact not only the well-being of student musicians but also their self-fulfillment and learning capacity. These issues justify the need for health support in music studies. It is currently recommended to develop health promotion approaches that integrate knowledge about health, self-assessment of risk factors, and the adoption of good daily habits. These approaches are most effective when tailored to the specific needs of musicians.

This study will assess a preventive, digital intervention for student musicians over a 12-week period. The three groups involved are: GAppE (stand-alone app intervention plus 5 educational group sessions), GApp (app intervention used independently), and GC (no intervention).

Health knowledge, physical, psychological, and social well-being, as well as daily life and work habits, will be assessed at three time points: 1) before the intervention, 2) 6 months after the start of the intervention, and 3) 12 weeks after the start of the intervention in all 3 groups.

Moreover, after 6 and 12 weeks, participants in the GAppE and GApp groups will also evaluate their satisfaction with the app-based preventive intervention using standardized questionnaires.

The hypothesis is that the intervention will be feasible, useful, and appreciated, and that it will have beneficial health outcomes, particularly when combined with educational group sessions.

Conditions
Healthy Adults
Being tested
GApp, GappE
Keywords
Prevention, Student musicians, Digital tool, Health knowledge

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GAppBehavioural

    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.

  • GappEBehavioural

    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).

Study groups in NCT07033793
Study groupRoleWhat they receive
GCNo interventionControl group with no intervention.
GAppExperimentalPreventive advice with digital support
Receives: Behavioral: GApp
GappEExperimentalPreventive advice with digital support + 5 educational sessions
Receives: Behavioral: GappE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline.

  2. 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.

    Measured: From the start of the intervention to 12 weeks.

  3. 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).

    Measured: 6 and 12 weeks after the start of intervention.

  4. 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.

    Measured: 6 and 12 weeks after the start of intervention.

  5. 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).

    Measured: 6 and 12 weeks after the start of intervention.

Secondary outcomes (11)
  1. Assessment of the prevalence of Playing-related Muscoskeletal Disorders by using the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians (MPIIQM).

    This questionnaire is considered the gold standard for assessing musculoskeletal pain and discomfort related to practice of music. It evaluates the intensity of pain and its interference with musical performance with 22-items (8 for musician characteristics and 14 related with pain related with musical practice). The MPIIQM includes a subscale about pain intensity (0 to 40) and pain interference (0 to 50).

    Higher scores indicate greater pain intensity and interference with musical practice.

    Measured: Baseline, 6 weeks, 12 weeks after start of intervention

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

    The SF-36 assesses the perceived physical and mental quality of life across eight dimensions: physical functionning (10 items), role limitations (4 items); bodily pain (2 items); general health perceptions (5 items); energy/vitality (4 items); social functioning (2 items); emotional role limitations (3 items); general mental health (5 items) and health transition (1 item). The total score ranges from 0 to 30. Higher score indicates better perceived health-related quality of life.

    Measured: Baseline, 6 weeks, 12 weeks after start of intervention

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

    The questionnaire assesses professional health and psychosocial adaptation among musicians. It evaluates multiple dimensions relevant to musical performance, including 7 domains: satisfaction with professional achievement, confidence in stage situations, breathing while playing, satisfaction with posture, movement sensations, symptoms during performance, and perceived ability to meet musical demands. The total score ranges from 6 to 42. High score shows good adaptability to constraint. Changes in this score may reflect the impact of the preventive intervention on physical and mental health in the context of musical work.

    Measured: Baseline, 6 weeks, 12 weeks after start of intervention

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

    The Kessler Psychological Distress Scale (K10) is a validated 10-item self-report questionnaire designed to assess symptoms of anxiety and depression over the past 4 weeks. Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50. Low score indicates low levels of psychological distress and high scores indicate high levels of psychological distress. Since student musicians have a high level of general stress, a change will allow us to observe whether interventions have an effect on this risk factor.

    Measured: Baseline, 6 weeks, 12 weeks after start of intervention

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

    The K-MPAI-R is a validated 40-item with a 7-point Likert scale measuring anxiety related to music performance specific to the target population. Total score: 7 to 280 points. A high total score corresponds to high anxiety and distress regarding musical performance and vice versa. Since student musicians have a high level of performance-related stress, a change will allow us to observe whether interventions have an effect on this risk factor.

    Measured: Baseline, 6 weeks, 12 weeks after start of intervention

  6. General Fatigue Rating

    Following recommendations from a Delphi consensus study, a general fatigue rating is collected. Participants rate their current level of fatigue using a single-item self-report scale ranging from 0 (no fatigue) to 10 (maximum fatigue), providing a quick global indicator of perceived fatigue.

    Measured: Baseline, 6 weeks, 12 weeks after the start of the intervention.

  7. Fatigue Change and Recovery as Measured by the McCrary Fatigue Scale

    Fatigue will also be assessed using the McCrary Fatigue Questionnaire. It is a 5-item validated scale developed specifically for musicians. It evaluates dimensions such as pain, sleep, recovery, workload, and physical condition. Items are rated on a 0-10 scale. A high total score represents greater fatigue. The intervention includes education on fatigue management, which may impact both perceived and reported fatigue levels.

    Measured: Baseline, 6 weeks, 12 weeks after the start of the intervention.

  8. Occupational Balance as Measured by OBQ

    The Occupational Balance Questionnaire (OBQ) is used to evaluate satisfaction with how time is spent and the variety of activities undertaken. A 13-item self-report scale. Each item is scored 0-3; total score range: 0-39. Higher score represents better occupational balance.The advice includes recommendations for time management, periodization, and health-promoting activities. A change will highlight whether the interventions have an effect on occupational balance.

    Measured: Baseline, 6 weeks, 12 weeks after start of intervention

  9. Change in Musicians' Health Literacy Scores Measured by the MHL-Q19 Questionnaire

    Health literacy will be assessed using the Musicians' Health Literacy Questionnaire (MHL-Q19), a 19-item scale developed specifically for student musicians. It evaluates the ability to access, understand, and apply health information across clinical care, prevention, and health promotion contexts. Each item is scored as either difficult (0) or easy (1), producing a total score ranging from 0 to 19. Scores are categorized as:

    • Inadequate (0-9)
    • Problematic (10-14)
    • Sufficient (15-19). The app includes information on health and good behaviors. A change will highlight the effects on health knowledge.

    Measured: Baseline, 6 weeks, 12 weeks after start of intervention

  10. Change in the Self-Perceived Musical Performance Quality Assessed by a Visual Analog Scale

    Self-perceived performance quality will be measured using a Visual Analog Scale (VAS) ranging from 0 (lowest imaginable performance) to 10 (best imaginable performance). Participants will rate their average performance quality over the previous 3 days. This outcome assesses the participant's subjective perception of their musical performance and whether it is influenced by the preventive intervention.

    Measured: Baseline, 6 weeks, 12 weeks after start of intervention

  11. General Self-Efficacy (GSES)

    The General Self-Efficacy Scale (GSES) assesses confidence in one's coping ability in difficult situations with 10-items. Each item is evaluated with a 4-point scale (1 = not at all true and 4 = absolutely true). The total score ranges from 10 to 40. Higher scores reflect stronger self-efficacy.

    Measured: Baseline, 6 weeks, 12 weeks after start of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2025
  2. Study start1 Sep 2025
  3. Primary completion31 Mar 2026
  4. Study completion31 Aug 2026 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07033793
Sponsor's protocol ID
HarMoNie-129810
Other IDs
2025-00300, 2025
Acronym
HarMoNie
Status last verified
Jun 2026
First submitted
4 Jun 2025
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39616356

Questions about this trial

What is this clinical trial studying?

A study testing GApp and GappE in people with Healthy Adults, run by Anne-Violette Bruyneel at 1 site in Switzerland.

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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. 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 Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

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?

Participant Interest in the App-Based Intervention (time frame: At baseline.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07033793, which also lists 1 linked publication.

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 4 Jun 2026.

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