Orofacial PainNCT06618898
Orofacial Pain in Woodwind and Cello Musicians in German Orchestras
An observational study of Orofacial Pain and Sleep Problems, run by University Medical Center Goettingen at 1 site in Germany.
Trial summary
Professional musicians in German professional orchestras represent a population group that has received little attention so far, despite being exposed to a variety of work-related factors that may pose potential health risks to the orofacial system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orofacial Pain, Sleep Problems
- What is being tested?
- online questionnaire
- How many people
- 245 participants
- Where
- 1 siteGermany
- Study dates
- 4 Nov 2024to 26 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Professional musicians whose primary instruments are oboe, flute, clarinet, bassoon, or cello in German professional orchestras.
Who may be able to join
- musicians whose primary instruments are oboe, flute, clarinet, bassoon, or cello
- at least 12 months of employment or freelance work in the past 5 years with a German professional orchestra
Who cannot join
- consent not given
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Orofacial Pain and Oral Health-related Quality of Life in Woodwind and Cello Musicians in German Orchestras
Professional musicians in German professional orchestras represent a population group that has received little attention so far, despite being exposed to a variety of work-related factors that may pose potential health risks to the orofacial system. These factors include environmental noise, irregular working hours, tight schedules, and high demands for quality and discipline, all of which can lead to stress, sleep disturbances, and physical impairments. This prospective, non-interventional survey study aims to assess the health challenges faced by woodwind players (oboe, flute, clarinet, bassoon). It will explore the relationship between the type of instrument played, orofacial pain, sleep problems, and oral health-related quality of life (OHRQoL). Woodwind players, due to their playing techniques, may be more susceptible to orofacial complaints, which could negatively impact their quality of life. A control group of cellists, whose playing techniques put less strain on the orofacial system, will be used for comparison. Participation will be via an online questionnaire targeting musicians who have been employed in a German professional orchestra for at least 12 months.
- Conditions
- Orofacial Pain, Sleep Problems
- Being tested
- online questionnaire
- Keywords
- Musicals, orchestra, orofacial pain, quality of life, stress, sleep disorders
- Medical subject headings
- Facial Pain, Parasomnias, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online questionnaireOther
Also called questionnaire
The online questionnaire includes demographic data: age, gender, instrument (oboe, flute, clarinet, bassoon, and cello), years of service, number of services in the last six months and specific questions about orofacial pain, sleep bruxism, stress experiences, and sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| oboe | Woodwind players in German professional orchestras who play the oboe Receives: Other: online questionnaire | |
| flute | Woodwind players in German professional orchestras who play the flute Receives: Other: online questionnaire | |
| clarinet | Woodwind players in German professional orchestras who play the clarinet Receives: Other: online questionnaire | |
| bassoon | Woodwind players in German professional orchestras who play the bassoon Receives: Other: online questionnaire | |
| cello | musicians in German professional orchestras who play the cello Receives: Other: online questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Online-Questionnaire
Completion of a web based questionnaire; Oral health impact profile 14: minimum value 0 and maximum value 56, higher scores indicating poor oral health related quality of life
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start4 Nov 2024
- Primary completion26 Jan 2025
- Study completion26 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orofacial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Marschner, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618898
- Sponsor's protocol ID
- 13/9/24
- Status last verified
- Feb 2025
- First submitted
- 27 Sep 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marschner F, Sokolowski A, Sokolowski A, Biermann J, Wiegand A. Orofacial pain and oral health-related quality of life in woodwind and cello musicians in German orchestras: an online based questionnaire study. J Occup Med Toxicol. 2025 Jun 6;20(1):19. doi: 10.1186/s12995-025-00467-4.
PubMed 40481603
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orofacial Pain and Oral Health-related Quality of Life in Woodwind and Cello Musicians in German Orchestras
- ClinicalTrials.gov ID
- NCT06618898
- Acronym / sponsor ID
- 13/9/24
- Conditions
- Orofacial Pain, Sleep Problems
- Keywords
- Musicals, orchestra, orofacial pain, quality of life, stress, sleep disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 26 Jan 2025 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Professional musicians in German professional orchestras represent a population group that has received little attention so far, despite being exposed to a variety of work-related factors that may pose potential health risks to the orofacial system. These factors include environmental noise, irregular working hours, tight schedules, and high demands for quality and discipline, all of which can lead to stress, sleep disturbances, and physical impairments. This prospective, non-interventional survey study aims to assess the health challenges faced by woodwind players (oboe, flute, clarinet, bassoon). It will explore the relationship between the type of instrument played, orofacial pain, sleep problems, and oral health-related quality of life (OHRQoL). Woodwind players, due to their playing techniques, may be more susceptible to orofacial complaints, which could negatively impact their quality of life. A control group of cellists, whose playing techniques put less strain on the orofacial system, will be used for comparison. Participation will be via an online questionnaire targeting musicians who have been employed in a German professional orchestra for at least 12 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| oboe | – | Other: online questionnaireWoodwind players in German professional orchestras who play the oboe |
| flute | – | Other: online questionnaireWoodwind players in German professional orchestras who play the flute |
| clarinet | – | Other: online questionnaireWoodwind players in German professional orchestras who play the clarinet |
| bassoon | – | Other: online questionnaireWoodwind players in German professional orchestras who play the bassoon |
| cello | – | Other: online questionnairemusicians in German professional orchestras who play the cello |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Professional musicians whose primary instruments are oboe, flute, clarinet, bassoon, or cello in German professional orchestras.
Key inclusion criteria (2 listed)
- musicians whose primary instruments are oboe, flute, clarinet, bassoon, or cello
- at least 12 months of employment or freelance work in the past 5 years with a German professional orchestra
Key exclusion criteria (1 listed)
- consent not given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online questionnaireAlso: questionnaireThe online questionnaire includes demographic data: age, gender, instrument (oboe, flute, clarinet, bassoon, and cello), years of service, number of services in the last six months and specific questions about orofacial pain, sleep bruxism, stress experiences, and sleep quality. | Other | bassoon, cello, clarinet, flute, oboe |
Primary outcome
Online-Questionnaire
Time frame: 10 minutes
Completion of a web based questionnaire; Oral health impact profile 14: minimum value 0 and maximum value 56, higher scores indicating poor oral health related quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Derived from this study: PubMed 40481603Marschner F, Sokolowski A, Sokolowski A, Biermann J, Wiegand A. Orofacial pain and oral health-related quality of life in woodwind and cello musicians in German orchestras: an online based questionnaire study. J Occup Med Toxicol. 2025 Jun 6;20(1):19. doi: 10.1186/s12995-025-00467-4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orofacial Pain and Sleep Problems, run by University Medical Center Goettingen at 1 site in Germany.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 11 Feb 2025. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Online-Questionnaire (time frame: 10 minutes). 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 NCT06618898, 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 11 Feb 2025.