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Exercises and Performance Anxiety Among Young Instrumentalists.

Primary Purpose

Musculoskeletal Pain, Performance Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Physical Exercises
Sponsored by
Anna Cygańska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Musculoskeletal Pain focused on measuring Occupational Stress, Musculoskeletal Pain, Performance anxiety, Occupational Diseases, Exercise Therapy

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Józef Piłsudski University of Physical Education in WarsawRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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;
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;
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;
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;
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;

Secondary Outcome Measures

Flexibility level
Trunk flexion assessment in standing in centimeters
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);
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).
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;
Anxiety level during last performance
Authors own questionnaire; the higher the score, the greater the stage fright; from 5 to 30;
Assessment of exercises an program
Authors own questionnaire; the higher the score, the higher the rating of the original exercise program; from16 to 96;

Full Information

First Posted
November 29, 2022
Last Updated
June 5, 2023
Sponsor
Anna Cygańska
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1. Study Identification

Unique Protocol Identification Number
NCT05640557
Brief Title
Exercises and Performance Anxiety Among Young Instrumentalists.
Official Title
The Effect of an Exercise Program Designed for Young Instrumentalists (Musicians) on Music Performance Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
September 28, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Cygańska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Performance Anxiety
Keywords
Occupational Stress, Musculoskeletal Pain, Performance anxiety, Occupational Diseases, Exercise Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There will be two groups: study group (taking a part in the exercise program) and control (no intervention).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Exercises
Intervention Description
An original, noninvasive exercise program
Primary Outcome Measure Information:
Title
Anxiety level - total
Description
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;
Time Frame
Before starting the study
Title
Anxiety level - specific psychological predispositions (SPP)
Description
Kenny Music Performance Anxiety Inventory - Certified Polish translation; the higher the score, the worse the specific psychological predispositions; from 0 to 96;
Time Frame
Change between Baseline and post-treatment, 6 weeks
Title
Pain Interference
Description
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;
Time Frame
Change between Baseline and post-treatment, 6 weeks
Title
Pain Intensity
Description
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;
Time Frame
Change between Baseline and post-treatment, 6 weeks
Title
Anxiety level - biological predisposition (BP)
Description
Kenny Music Performance Anxiety Inventory - Certified Polish translation; the higher the score, the worse the biological predisposition; from 0 to 30;
Time Frame
Change between Baseline and post-treatment, 6 weeks
Secondary Outcome Measure Information:
Title
Flexibility level
Description
Trunk flexion assessment in standing in centimeters
Time Frame
Change between Baseline and post-treatment, 6 weeks
Title
Resilience level
Description
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);
Time Frame
Before starting the study
Title
Changes in algometric measurements
Description
The algometric measurement concerns the assessment of muscle pressure sensitivity - pain threshold in kg/cm2 made using the Pain Test FPX Algometer (Wagner).
Time Frame
Change between Baseline and post-treatment, 6 weeks
Title
Anxiety level - general psychological predisposition (GPP)
Description
Kenny Music Performance Anxiety Inventory - Certified Polish translation; the higher the score, the worse the general psychological predisposition; from 0 to 114;
Time Frame
Before starting the study
Title
Anxiety level during last performance
Description
Authors own questionnaire; the higher the score, the greater the stage fright; from 5 to 30;
Time Frame
Change between Baseline and post-treatment, 6 weeks
Title
Assessment of exercises an program
Description
Authors own questionnaire; the higher the score, the higher the rating of the original exercise program; from16 to 96;
Time Frame
After 6 weeks of exercise program
Other Pre-specified Outcome Measures:
Title
Age
Description
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
Time Frame
Before starting the study
Title
Gender
Description
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
Time Frame
Before starting the study
Title
Instrument played
Description
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
Time Frame
Before starting the study
Title
Practice time (years)
Description
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
Time Frame
Before starting the study
Title
Weekly practice time (hours)
Description
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
Time Frame
Before starting the study
Title
Presence of pain
Description
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
Time Frame
Baseline and after 6 weeks
Title
Localisation of pain (number)
Description
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
Time Frame
Baseline and after 6 weeks
Title
Localisation of pain (body area)
Description
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
Time Frame
Baseline and after 6 weeks
Title
Prevalence of pain
Description
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P)
Time Frame
Baseline and after 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna K. Cygańska, Doctor
Phone
506 915 950
Email
anna.katarzyna.cyganska@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna K. Cygańska, Doctor
Organizational Affiliation
Józef Piłsudski University of Physical Education in Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Józef Piłsudski University of Physical Education in Warsaw
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Cygańska, master
Phone
+ 48 22 834 04 31
Ext
359, 508
Email
anna.katarzyna.cyganska@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercises and Performance Anxiety Among Young Instrumentalists.

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