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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05048446
Other study ID # ID0035
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2021
Est. completion date January 18, 2022

Study information

Verified date August 2022
Source University of Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date January 18, 2022
Est. primary completion date January 7, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - active professional musicians Exclusion Criteria: - non-active or non-practicing professional musicians

Study Design


Related Conditions & MeSH terms


Intervention

Other:
observational
Non intervention

Locations

Country Name City State
Spain Gemma Espí López Valencia
Spain Gemma Victoria Espí-López Valencia

Sponsors (1)

Lead Sponsor Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 day
Primary 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. 1 day
Secondary 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". 1 day
Secondary 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.
1 day
Secondary 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). .
1 day
Secondary 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. 1 day
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