- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05640557
Exercises and Performance Anxiety Among Young Instrumentalists.
The Effect of an Exercise Program Designed for Young Instrumentalists (Musicians) on Music Performance Anxiety
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna K. Cygańska, Doctor
- Phone Number: 506 915 950
- Email: anna.katarzyna.cyganska@gmail.com
Study Locations
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Warsaw, Poland
- Recruiting
- Józef Piłsudski University of Physical Education in Warsaw
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Contact:
- Anna Cygańska, master
- Phone Number: 359, 508 + 48 22 834 04 31
- Email: anna.katarzyna.cyganska@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 (<10ᵒ 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
The participants of the study will take part in exercises (proprietary exercise program), 2 times per week, 45 minutes, for 6 weeks.
They will be measured before and after the 6-week exercise program.
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An original, noninvasive exercise program
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No Intervention: Control group
The study participants will not be subjected to any intervention, they will be measured twice, 6 weeks apart.
They will be asked to lead their habitual lifestyle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety level - total
Time Frame: Before starting the study
|
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;
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Before starting the study
|
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Anxiety level - specific psychological predispositions (SPP)
Time Frame: Change between Baseline and post-treatment, 6 weeks
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Kenny Music Performance Anxiety Inventory - Certified Polish translation; the higher the score, the worse the specific psychological predispositions; from 0 to 96;
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Change between Baseline and post-treatment, 6 weeks
|
|
Pain Interference
Time Frame: Change between Baseline and post-treatment, 6 weeks
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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;
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Change between Baseline and post-treatment, 6 weeks
|
|
Pain Intensity
Time Frame: Change between Baseline and post-treatment, 6 weeks
|
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;
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Change between Baseline and post-treatment, 6 weeks
|
|
Anxiety level - biological predisposition (BP)
Time Frame: Change between Baseline and post-treatment, 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Flexibility level
Time Frame: Change between Baseline and post-treatment, 6 weeks
|
Trunk flexion assessment in standing in centimeters
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Change between Baseline and post-treatment, 6 weeks
|
|
Changes in algometric measurements
Time Frame: Change between Baseline and post-treatment, 6 weeks
|
The algometric measurement concerns the assessment of muscle pressure sensitivity - pain threshold in kg/cm2 made using the Pain Test FPX Algometer (Wagner).
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Change between Baseline and post-treatment, 6 weeks
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Resilience level
Time Frame: Before starting the study
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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);
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Before starting the study
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Anxiety level - general psychological predisposition (GPP)
Time Frame: Before starting the study
|
Kenny Music Performance Anxiety Inventory - Certified Polish translation; the higher the score, the worse the general psychological predisposition; from 0 to 114;
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Before starting the study
|
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Anxiety level during last performance
Time Frame: Change between Baseline and post-treatment, 6 weeks
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Authors own questionnaire; the higher the score, the greater the stage fright; from 5 to 30;
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Change between Baseline and post-treatment, 6 weeks
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Assessment of exercises an program
Time Frame: After 6 weeks of exercise program
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Authors own questionnaire; the higher the score, the higher the rating of the original exercise program; from16 to 96;
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After 6 weeks of exercise program
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: Before starting the study
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The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
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Before starting the study
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Gender
Time Frame: Before starting the study
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The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
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Before starting the study
|
|
Instrument played
Time Frame: Before starting the study
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The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
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Before starting the study
|
|
Practice time (years)
Time Frame: Before starting the study
|
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
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Before starting the study
|
|
Weekly practice time (hours)
Time Frame: Before starting the study
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The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
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Before starting the study
|
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Presence of pain
Time Frame: Baseline and after 6 weeks
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The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
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Baseline and after 6 weeks
|
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Localisation of pain (number)
Time Frame: Baseline and after 6 weeks
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The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
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Baseline and after 6 weeks
|
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Localisation of pain (body area)
Time Frame: Baseline and after 6 weeks
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The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
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Baseline and after 6 weeks
|
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Prevalence of pain
Time Frame: Baseline and after 6 weeks
|
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
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Baseline and after 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna K. Cygańska, Doctor, Józef Piłsudski University of Physical Education in Warsaw
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SKE 01-26/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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