- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07714837
Orofacial Pain and Oral Health-Related Quality of Life in Musicians in German Amateur Orchestras (OSQ-MUS)
Orofacial Pain, Sleep-Related Problems, and Oral Health-Related Quality of Life Among Musicians in German Amateur Orchestras: A Cross-Sectional Online Survey
Study Overview
Status
Intervention / Treatment
Detailed Description
Background: Germany has both one of the world's highest densities of professional orchestras and a rich amateur orchestra landscape, with approximately 30,300 musicians active across 863 amateur orchestras (BDLO). While making music, amateur musicians are exposed to physical and psychological demands that may affect oral health. Orofacial pain in musicians has been associated with sleep bruxism, perceived stress, and reduced sleep quality, all of which may negatively affect OHRQoL. Instrument-specific oral effects have been described particularly for wind instrumentalists compared with other instrument groups (e.g., string and percussion), related to specific playing technique and the coordinated action of the orofacial musculature. Playing a wind instrument has been linked to temporomandibular dysfunction, orofacial pain, and increased masticatory muscle activity. Unlike professional musicians, amateur musicians often have more heterogeneous and less systematic instrumental training, so a suboptimal playing technique and unfavorable posture may contribute to muscular overload. To date, no systematically collected data on orofacial pain, sleep-related problems, and OHRQoL of amateur musicians in Germany are available.
Objective: To investigate orofacial pain, sleep-related problems, and OHRQoL among musicians in German amateur orchestras and to identify possible differences between instrument groups (woodwind, brass, string, percussion, and other instruments such as piano, harp, celesta).
Hypothesis: Amateur musicians who play wind instruments (woodwind and brass) more frequently suffer from orofacial pain and experience a different OHRQoL than amateur musicians who play other instrument groups.
Methods: This is a monocentric, cross-sectional online survey. A standardized online questionnaire is distributed to all 863 German amateur orchestras and additionally disseminated via the BDLO newsletter. The questionnaire covers demographic data (age, sex, instrument, duration of amateur orchestra membership) and specific questions on orofacial pain, sleep bruxism, perceived stress, and sleep quality. The German version of the OHIP-14 is used to assess OHRQoL. The survey is provided electronically via the University Medical Center Göttingen electronic survey system (EvaSys, ISO 27001 certified). Participation is voluntary and anonymous; completion of the questionnaire constitutes consent. Completion takes approximately 10 minutes, and the survey closes after 12 weeks for each participant. A reminder is sent to the orchestras and via the BDLO newsletter after 6 weeks.
Statistical analysis: Continuous variables are presented as mean ± standard deviation or as median with interquartile range; categorical variables as absolute and relative frequencies. Group comparisons use the chi-square test, t-test, Mann-Whitney U test, or Kruskal-Wallis test as appropriate. Multivariable logistic regression is used to identify independent predictors of the presence of orofacial pain, and linear regression for the OHIP-14 summary score, each adjusted for relevant covariates. Odds ratios are reported with 95% confidence intervals and adjusted for age and sex.
The study is conducted in accordance with the current version of the Declaration of Helsinki. The protocol is submitted to the Ethics Committee of the University Medical Center Göttingen prior to the start of the survey.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Felix Marschner, Dr, MSc
- Phone Number: +49 551 39-60870
- Email: felix.marschner@med.uni-goettingen.de
Study Locations
-
-
-
Göttingen, Germany, 37077
- University Medical Center Göttingen
-
Contact:
- Felix Marschner, Dr, MSc
- Phone Number: +49 551 39-60870
- Email: felix.marschner@med.uni-goettingen.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
- Active membership in a German amateur orchestra
- Consent to study participation (given by completing the questionnaire)
Exclusion Criteria:
- Age < 18 years
- Missing / declined consent to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Orchestra musicians
musicians in German amateur orchestras
|
Percentage (%) of surveyed musicians with presence of orofacial pain and other studied conditions like sleep bruxism, sleep disorders, and Oral Health-Related Quality of Life
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of orofacial pain
Time Frame: 10 minutes
|
Presence of orofacial pain - self-reported via standardized questionnaire, compared between instrument groups.
|
10 minutes
|
|
Oral Health-Related Quality of Life
Time Frame: 10 minutes
|
Oral Health-Related Quality of Life (OHIP-14 summary score) - German version; summary score range 0-56, higher scores indicating worse OHRQoL; compared between instrument groups.
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported sleep bruxism questionnaire
Time Frame: 10 minutes
|
Prevalence of self-reported sleep bruxism, self-reported via standardized questionnaire, compared between instrument groups.
|
10 minutes
|
|
Self-reported perceived stress questionnaire
Time Frame: 10 minutes
|
Perceived stress, self-reported via standardized questionnaire, compared between instrument groups.
|
10 minutes
|
|
Self-reported sleep quality questionnaire
Time Frame: 10 minutes
|
Self-reported sleep quality, self-reported via standardized questionnaire, compared between instrument groups.
|
10 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Felix Marschner, Dr, MSc, University Medical Center Göttingen
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24/6/26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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