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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05640557
Other study ID # SKE 01-26/2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 13, 2022
Est. completion date December 30, 2023

Study information

Verified date June 2023
Source Józef Pilsudski University of Physical Education
Contact Anna K. Cyganska, Doctor
Phone 506 915 950
Email anna.katarzyna.cyganska@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the impact of an original exercise program intended for students of the University of Music on dealing with stage fright and its psychophysical symptoms.


Description:

The study group covers students of a music university who play various musical instruments. Participants will be divided into the experimental and control groups. The study duration is scheduled to be 6 weeks. The control group will not have any intervention. The experimental group will undertake 45 mins exercise classes twice a week. Each exercise session will consist of an initial part (warm-up), a main part with exercises designed to strengthen the postural muscles and stretch the contracted muscle groups that are especially prone to pain in musicians (back and upper limbs), and a final part of calming and breathing exercises. At the beginning and at the end of the study, participants of both groups will be asked to complete a Polish version of validated psychological questionnaires: Kenny Music Performance Anxiety Inventory-Revised, Ogińska-Bulik's & Juczyński's Resiliency Assessment Scale (SPP-25), Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians of the Polish Population (MPIIQM-P) and one original questionnaire assessing the stress level before, during and after a performance. All participants will also undergo physical examination. A measurement of the range of motion of trunk flexion in standing (cm) and the algometric measurement of the pain threshold (kg/cm2) of selected back muscles (trapezius muscles, upper and lower and levator scapula) on the right and left sides of the body. Algometric measurements will be made using the Pain Test FPX algometer Algometer (Wagner). Statistical analysis. The variables will be coded and analyzed using the STATISTICA program. Baseline demographics will be compared between groups (independent t-tests, chi-square tests). Two-way mixed-model analyses of variance (ANOVA) will explore the effect of the exercise program on symptoms and anxiety.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 30, 2023
Est. primary completion date September 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - playing on a musical instrument for at least 5 years - age 18 to 35 - consent to participate in the study - participation in at least 8 meetings (exercise) within 6 weeks Exclusion Criteria: - current (last 3 months) locomotor injuries (fractures, sprains, dislocations), medical contraindications to exercise, confirmed by a medical opinion - neurological and oncological diseases confirmed by a medical diagnosis - previous spine surgeries, scoliosis confirmed by radiograph (<10? Cobb) - regular intake of muscle relaxants, painkillers, anti-inflammatory drugs, anti-depressants - age under 18 or over 35 - no consent to participate in the study to participate in the study.

Study Design


Intervention

Other:
Physical Exercises
An original, noninvasive exercise program

Locations

Country Name City State
Poland Józef Pilsudski University of Physical Education in Warsaw Warsaw

Sponsors (1)

Lead Sponsor Collaborator
Anna Cyganska

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Other Age The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P) Before starting the study
Other Gender The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P) Before starting the study
Other Instrument played The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P) Before starting the study
Other Practice time (years) The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P) Before starting the study
Other Weekly practice time (hours) The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P) Before starting the study
Other Presence of pain The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P) Baseline and after 6 weeks
Other Localisation of pain (number) The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P) Baseline and after 6 weeks
Other Localisation of pain (body area) The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P) Baseline and after 6 weeks
Other Prevalence of pain The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P) Baseline and after 6 weeks
Primary Anxiety level - total Kenny Music Performance Anxiety Inventory - Certified Polish translation; the total score in the questionnaire shows the strength of stage fright; the higher the score, the greater the stage fright; from 0 to 240; Before starting the study
Primary Anxiety level - specific psychological predispositions (SPP) Kenny Music Performance Anxiety Inventory - Certified Polish translation; the higher the score, the worse the specific psychological predispositions; from 0 to 96; Change between Baseline and post-treatment, 6 weeks
Primary Pain Interference The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P); from 0 to 50, the higher the score, the greater the pain interference; Change between Baseline and post-treatment, 6 weeks
Primary Pain Intensity The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P); from 0 to 40, the higher the score, the greater the pain intensity; Change between Baseline and post-treatment, 6 weeks
Primary Anxiety level - biological predisposition (BP) Kenny Music Performance Anxiety Inventory - Certified Polish translation; the higher the score, the worse the biological predisposition; from 0 to 30; Change between Baseline and post-treatment, 6 weeks
Secondary Flexibility level Trunk flexion assessment in standing in centimeters Change between Baseline and post-treatment, 6 weeks
Secondary Resilience level The Polish Version of the Resilience Scale 25; The higher the score obtained on the scale, the higher it is resilience is presented by the person completing the questionnaire (from 0 to 100; 0-65 - means low resilience, 66-77 - means medium resilience, and 78-100 means high resilience); Before starting the study
Secondary Changes in algometric measurements The algometric measurement concerns the assessment of muscle pressure sensitivity - pain threshold in kg/cm2 made using the Pain Test FPX Algometer (Wagner). Change between Baseline and post-treatment, 6 weeks
Secondary Anxiety level - general psychological predisposition (GPP) Kenny Music Performance Anxiety Inventory - Certified Polish translation; the higher the score, the worse the general psychological predisposition; from 0 to 114; Before starting the study
Secondary Anxiety level during last performance Authors own questionnaire; the higher the score, the greater the stage fright; from 5 to 30; Change between Baseline and post-treatment, 6 weeks
Secondary Assessment of exercises an program Authors own questionnaire; the higher the score, the higher the rating of the original exercise program; from16 to 96; After 6 weeks of exercise program
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