Musculoskeletal PainSActMWQoLMUNCT05048446
Physical and Work Variables in Professional Musicians
An observational study of Musculoskeletal Pain, run by University of Valencia at 2 sites in Spain.
Trial summary
In professional musicians there are characteristic diseases. In this area there is no preventive culture and many musicians end their professional careers due to ailments and pathologies that cause the abandonment of the profession or they learn to live and play with pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- observational
- How many people
- 156 participants
- Where
- 2 sitesSpain
- Study dates
- 10 Oct 2021to 18 Jan 2022
- How long will I take part?
- 1 Day
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Professional musicians of orchestras and bands
Who may be able to join
- active professional musicians
Who cannot join
- non-active or non-practicing professional musicians
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Gemma Espí López
Valencia, 46010
Gemma Victoria Espí-López
Valencia, 46010
About this study
Official title: Physical Activity, Musculoskeletal Disorders, Perception of Emotional Work Well-being and Quality of Life in Professional Musicians
In professional musicians there are characteristic diseases. In this area there is no preventive culture and many musicians end their professional careers due to ailments and pathologies that cause the abandonment of the profession or they learn to live and play with pain. It is a very demanding profession that requires many hours of training without respecting the necessary rest, which undoubtedly produces fatigue and muscle overload, neurological disorders, etc. Also, the demands to achieve perfection lead to serious work problems.
Given that it is a profession that suffers from pain and psychosomatic alterations and that is often accompanied by emotional alterations due to work demands, it is necessary to know this problem and to what extent it affects the musician to be able to act from different areas and improve his well-being.
The objective is to know specifically the characteristics of professional musicians, their impact variables, both musculoskeletal and emotional, variables related to the workplace and to evaluate their quality of life.
Read the detailed description
MATERIAL AND METHODS Subjects. Professional orchestral and band musicians between the ages of 18 and 65.
Study design. Descriptive study to be carried out at the University of Valencia. To do this, a survey will be carried out through an online platform. All participants will sign the informed consent and the study will be carried out in compliance with the data confidentiality guidelines. To start the study, the approval of the Ethics Committee of the University of Valencia will be necessary and it will be included in an international registry.
Evaluation. In the first place, the anthropometric data (age, sex, weight, height) and the characteristics of the sample will be taken through an interview designed for this study that will contain questions about the job and instruments they practice. Subsequently, the subjects will fill in the assessment instruments that include the physical activity they perform, the musculoskeletal alterations, workplace harassment, professional burnout, quality of life and anxiety and depression.
Statistic analysis. The variables will be coded and analyzed using the SPSS v.26 program.
- Conditions
- Musculoskeletal Pain
- Being tested
- observational
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
Non intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
By Ipaq Short Form. The short form records activity at four levels of intensity: 1) vigorous intensity activity such as aerobics, 2) moderate intensity activity such as leisure riding a bike, 3) walking and 4) sitting.
Measured: 1 day
Musculoskeletal disorders
Will be evaluated by the Nordic questionnaire, this tool is used to detect symptoms musculoskeletal such as pain, discomfort, numbness or tingling. It includes two important sections: The first is choice questions mandatory in which the subject marks the areas of the body where pain occurs; The second section contains related questions on the functional impact of pain symptoms. Also the duration of problem, if it has been evaluated by a health professional and the evolution of pain. This questionnaire does not have a score as such, it does not have a scale to assess it, but rather what, based on the data, the analysis is extracted for each question.
Measured: 1 day
Secondary outcomes (4)
Workplace Harassment
To assess mobbing at work we used the Short-Negative Acts Questionnaire (NAQ). It consists of 9 items of the NAQ. This is a questionnaire that collects typical harassment behaviors, with respect to which the subject must indicate the degree to which they have suffered such behaviors during the last six months. The response scale consists of five alternatives from 1 ("never") to 5 ("daily"). Some examples of the items included are: "Gossip and rumors have spread about me", "I have been the object of offenses about my person or my private life".
Measured: 1 day
Health
The SF-8 questionnaire is structured with eight articles. It is divided into eight subscales (physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role mental and mental health) and two summary components (physical and mental) through which the the results are expressed.
Scores on the subscales and summary. The components are presented as a mean score of 50. Therefore, scores below 50 points correspond to deviations from normality and indicate a poorer quality of life, while scores above 50 the points represent a better quality of life.
Measured: 1 day
Anxiety and depression
The Golberg scale will be used, a test that orients the diagnosis towards anxiety or depression or both, and discriminates between them and measures their respective intensities. This scale contains 2 subscales with 9 questions each:
- Anxiety subscale (questions 1-9). If from questions 1-4, a minimum of 2 questions are not answered in the affirmative, the test is not carried out.
- Depression subscale (questions 10-18). If from questions 10-13, a minimum of 1 questions are not answered in the affirmative, the test is not carried out.
For its interpretation, the affirmative responses of the Anxiety scale and those of the Depression scale are counted. The cut-off points are 4 or more for the Anxiety subscale and 2 or more for Depression, with scores that are higher the more severe the problem (the maximum possible being 9 in each of the subscales). .
Measured: 1 day
Professional burnout
The Brief Burnout Questionnaire (CBB) will be used. This questionnaire aims to define the Burnout Syndrome or professional burnout syndrome and understand its dimensions. Burnout Syndrome can be defined as the symptoms of exhaustion and emotional exhaustion, the presence of depersonalization and the lack of personal fulfillment that is generated through a process of work stress maintained over time. Three dimensions are contemplated that include the previous factors of Burnout, the development of Burnout Syndrome and the consequences of this Syndrome. The antecedent factors of Burnout include items related to dissatisfaction with the task performed and with the organization in the workplace. The CBB questionnaire consists of 21 items that are evaluated by quantifying the global affectation of the subject by Burnout Syndrome in low, medium or high affectation in each of the three categories mentioned above.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start10 Oct 2021
- Primary completion7 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal 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
- Cross-sectional
- Enrolment
- 156 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
- Investigators
- Gemma V E Espí-López, Dr, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048446
- Sponsor's protocol ID
- ID0035
- Acronym
- SActMWQoLMU
- Status last verified
- Aug 2022
- First submitted
- 8 Sep 2021
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Musculoskeletal Disorders, Perception of Emotional Work Well-being and Quality of Life in Professional Musicians
- ClinicalTrials.gov ID
- NCT05048446
- Acronym / sponsor ID
- SActMWQoLMU / ID0035
- Conditions
- Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 17 Sep 2021 (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.
In professional musicians there are characteristic diseases. In this area there is no preventive culture and many musicians end their professional careers due to ailments and pathologies that cause the abandonment of the profession or they learn to live and play with pain. It is a very demanding profession that requires many hours of training without respecting the necessary rest, which undoubtedly produces fatigue and muscle overload, neurological disorders, etc. Also, the demands to achieve perfection lead to serious work problems.
Given that it is a profession that suffers from pain and psychosomatic alterations and that is often accompanied by emotional alterations due to work demands, it is necessary to know this problem and to what extent it affects the musician to be able to act from different areas and improve his well-being.
The objective is to know specifically the characteristics of professional musicians, their impact variables, both musculoskeletal and emotional, variables related to the workplace and to evaluate their quality of life.
Detailed description
MATERIAL AND METHODS Subjects. Professional orchestral and band musicians between the ages of 18 and 65.
Study design. Descriptive study to be carried out at the University of Valencia. To do this, a survey will be carried out through an online platform. All participants will sign the informed consent and the study will be carried out in compliance with the data confidentiality guidelines. To start the study, the approval of the Ethics Committee of the University of Valencia will be necessary and it will be included in an international registry.
Evaluation. In the first place, the anthropometric data (age, sex, weight, height) and the characteristics of the sample will be taken through an interview designed for this study that will contain questions about the job and instruments they practice. Subsequently, the subjects will fill in the assessment instruments that include the physical activity they perform, the musculoskeletal alterations, workplace harassment, professional burnout, quality of life and anxiety and depression.
Statistic analysis. The variables will be coded and analyzed using the SPSS v.26 program.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Professional musicians of orchestras and bands
Key inclusion criteria (1 listed)
- active professional musicians
Key exclusion criteria (1 listed)
- non-active or non-practicing professional musicians
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 |
|---|---|---|
| observationalNon intervention | Other | – |
Primary outcome
Physical activity
Time frame: 1 day
By Ipaq Short Form. The short form records activity at four levels of intensity: 1) vigorous intensity activity such as aerobics, 2) moderate intensity activity such as leisure riding a bike, 3) walking and 4) sitting.
Musculoskeletal disorders
Time frame: 1 day
Will be evaluated by the Nordic questionnaire, this tool is used to detect symptoms musculoskeletal such as pain, discomfort, numbness or tingling. It includes two important sections: The first is choice questions mandatory in which the subject marks the areas of the body where pain occurs; The second section contains related questions on the functional impact of pain symptoms. Also the duration of problem, if it has been evaluated by a health professional and the evolution of pain. This questionnaire does not have a score as such, it does not have a scale to assess it, but rather what, based on the data, the analysis is extracted for each question.
4 secondary outcomes
Workplace Harassment
Time frame: 1 day
Health
Time frame: 1 day
Anxiety and depression
Time frame: 1 day
Professional burnout
Time frame: 1 day
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 16 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Gemma V E Espí-López, Dr principal investigator
University of Valencia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain, run by University of Valencia at 2 sites in Spain.
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 1 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 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Physical activity (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2022.