- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Felix Marschner, Dr, MSc
- Telefonnummer: +49 551 39-60870
- E-mail: felix.marschner@med.uni-goettingen.de
Studiesteder
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Göttingen, Tyskland, 37077
- University Medical Center Göttingen
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Kontakt:
- Felix Marschner, Dr, MSc
- Telefonnummer: +49 551 39-60870
- E-mail: felix.marschner@med.uni-goettingen.de
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Orchestra musicians
musicians in German amateur orchestras
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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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Presence of orofacial pain
Tidsramme: 10 minutes
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Presence of orofacial pain - self-reported via standardized questionnaire, compared between instrument groups.
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10 minutes
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Oral Health-Related Quality of Life
Tidsramme: 10 minutes
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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.
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10 minutes
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Self-reported sleep bruxism questionnaire
Tidsramme: 10 minutes
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Prevalence of self-reported sleep bruxism, self-reported via standardized questionnaire, compared between instrument groups.
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10 minutes
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Self-reported perceived stress questionnaire
Tidsramme: 10 minutes
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Perceived stress, self-reported via standardized questionnaire, compared between instrument groups.
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10 minutes
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Self-reported sleep quality questionnaire
Tidsramme: 10 minutes
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Self-reported sleep quality, self-reported via standardized questionnaire, compared between instrument groups.
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10 minutes
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Felix Marschner, Dr, MSc, University Medical Center Göttingen
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 24/6/26
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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