- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Felix Marschner, Dr, MSc
- Telefonní číslo: +49 551 39-60870
- E-mail: felix.marschner@med.uni-goettingen.de
Studijní místa
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Göttingen, Německo, 37077
- University Medical Center Göttingen
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Kontakt:
- Felix Marschner, Dr, MSc
- Telefonní číslo: +49 551 39-60870
- E-mail: felix.marschner@med.uni-goettingen.de
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Presence of orofacial pain
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Self-reported sleep bruxism questionnaire
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Felix Marschner, Dr, MSc, University Medical Center Göttingen
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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