Musculoskeletal PainNCT05640557
Exercises and Performance Anxiety Among Young Instrumentalists.
A study testing Physical Exercises in people with Musculoskeletal Pain and Performance Anxiety, run by Anna Cygańska at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Performance Anxiety
- What is being tested?
- Physical Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 13 Dec 2022to 30 Dec 2023
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Józef Piłsudski University of Physical Education in Warsaw
Warsaw
Anna Cygańska, master, + 48 22 834 04 31 ext. 359, 508, anna.katarzyna.cyganska@gmail.com
About this study
Official title: The Effect of an Exercise Program Designed for Young Instrumentalists (Musicians) on Music Performance Anxiety
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.
Read the 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.
- Conditions
- Musculoskeletal Pain, Performance Anxiety
- Being tested
- Physical Exercises
- Keywords
- Occupational Stress, Musculoskeletal Pain, Performance anxiety, Occupational Diseases, Exercise Therapy
- Medical subject headings
- Musculoskeletal Pain, Occupational Stress, Occupational Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExercisesOther
An original, noninvasive exercise program
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Other: Physical Exercises |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: Before starting the study
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;
Measured: Change between Baseline and post-treatment, 6 weeks
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;
Measured: Change between Baseline and post-treatment, 6 weeks
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;
Measured: Change between Baseline and post-treatment, 6 weeks
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;
Measured: Change between Baseline and post-treatment, 6 weeks
Secondary outcomes (6)
Flexibility level
Trunk flexion assessment in standing in centimeters
Measured: Change between Baseline and post-treatment, 6 weeks
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);
Measured: Before starting the study
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).
Measured: Change between Baseline and post-treatment, 6 weeks
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;
Measured: Before starting the study
Anxiety level during last performance
Authors own questionnaire; the higher the score, the greater the stage fright; from 5 to 30;
Measured: Change between Baseline and post-treatment, 6 weeks
Assessment of exercises an program
Authors own questionnaire; the higher the score, the higher the rating of the original exercise program; from16 to 96;
Measured: After 6 weeks of exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start13 Dec 2022
- Primary completion28 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There will be two groups: study group (taking a part in the exercise program) and control (no intervention).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Cygańska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Cygańska, Józef Piłsudski University of Physical Education
- Investigators
- Anna K. Cygańska, Doctor, Principal investigator, Józef Piłsudski University of Physical Education in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640557
- Sponsor's protocol ID
- SKE 01-26/2022
- Status last verified
- Jun 2023
- First submitted
- 29 Nov 2022
- Last updated
- 6 Jun 2023
- 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 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Exercise Program Designed for Young Instrumentalists (Musicians) on Music Performance Anxiety
- ClinicalTrials.gov ID
- NCT05640557
- Acronym / sponsor ID
- SKE 01-26/2022
- Conditions
- Musculoskeletal Pain, Performance Anxiety
- Keywords
- Occupational Stress, Musculoskeletal Pain, Performance anxiety, Occupational Diseases, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anna CygańskaUniversity, hospital or other
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 28 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 7 Dec 2022 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be two groups: study group (taking a part in the exercise program) and control (no intervention).
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Physical ExercisesThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Physical ExercisesAn original, noninvasive exercise program | Other | Experimental group |
Primary outcome
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;
Anxiety level - specific psychological predispositions (SPP)
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 specific psychological predispositions; from 0 to 96;
Pain Interference
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 50, the higher the score, the greater the pain interference;
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;
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;
6 secondary outcomes
Flexibility level
Time frame: Change between Baseline and post-treatment, 6 weeks
Resilience level
Time frame: Before starting the study
Changes in algometric measurements
Time frame: Change between Baseline and post-treatment, 6 weeks
Anxiety level - general psychological predisposition (GPP)
Time frame: Before starting the study
Anxiety level during last performance
Time frame: Change between Baseline and post-treatment, 6 weeks
Assessment of exercises an program
Time frame: After 6 weeks of exercise program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- 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.
Anna K. Cygańska, Doctor principal investigator
Józef Piłsudski University of Physical Education in Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercises in people with Musculoskeletal Pain and Performance Anxiety, run by Anna Cygańska at 1 site in Poland.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna K. Cygańska, Doctor (506 915 950, anna.katarzyna.cyganska@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level - total (time frame: Before starting the study). The study lists 5 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 6 Jun 2023.