NCT05640557

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

December 13, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

November 29, 2022

Last Update Submit

June 5, 2023

Conditions

Keywords

Occupational StressMusculoskeletal PainPerformance anxietyOccupational DiseasesExercise Therapy

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • Flexibility level

    Change between Baseline and post-treatment, 6 weeks

  • Resilience level

    Before starting the study

  • Changes in algometric measurements

    Change between Baseline and post-treatment, 6 weeks

  • Anxiety level - general psychological predisposition (GPP)

    Before starting the study

  • Anxiety level during last performance

    Change between Baseline and post-treatment, 6 weeks

  • +1 more secondary outcomes

Other Outcomes (9)

  • Age

    Before starting the study

  • Gender

    Before starting the study

  • Instrument played

    Before starting the study

  • +6 more other outcomes

Study Arms (2)

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.

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.

Interventions

An original, noninvasive exercise program

Experimental group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Józef Piłsudski University of Physical Education in Warsaw

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

Musculoskeletal PainOccupational StressOccupational Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anna K. Cygańska, Doctor

    Józef Piłsudski University of Physical Education in Warsaw

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna K. Cygańska, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: There will be two groups: study group (taking a part in the exercise program) and control (no intervention).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, PhD in physical culture science

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 7, 2022

Study Start

December 13, 2022

Primary Completion

September 28, 2023

Study Completion

December 30, 2023

Last Updated

June 6, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations