The Application of Virtual Reality Exposure Versus Relaxation Training in Music Performance Anxiety

February 9, 2023 updated by: Wuerzburg University Hospital

Die Nutzung Virtueller Realität Zur Behandlung Von Auftrittsangst

The aim of the study is to investigate the effect of exposure treatment using virtual reality (VR) in musicians with performance anxiety compared to a relaxation technique on anxiety symptoms and corresponding cardiovascular parameters. The prospective, randomized clinical trial will include 46 musicians with musical performance anxiety (MPA). The experimental group will receive four exposure sessions in VR and the control group will receive four progressive muscle relaxation (PMR) sessions. Anxiety symptoms will be measured using a german version of the Performance Anxiety Questionnaire and a behavioral assessment test (BAT) before, after the treatment, and at 6-month follow-up. The cardiovascular reactivity will be assessed measuring the heart rate variability (HRV) throughout the BAT and the blood pressure before and after the BAT. Furthermore, blood and saliva samples will be collected before and after the BAT to assess endocrine stress parameters and epigenetic markers. The following hypotheses are derived: 1) Significant and lasting reduction of subjective MPA symptoms for the experimental group receiving VRET at T1 (post/ shortly after treatment) and T2 (follow-up/ 6 months after treatment) compared to T0 (pre/ before treatment). 2) Significant better reduction of subjective MPA symptoms for the experimental group receiving VRET compared to the control group receiving PMR at T1 (post/shortly after treatment) and T2 (follow-up/ 6 months after treatment) compared to T0 (pre/ before treatment). 3) The postulated effects in hypotheses 1 and 2 go along with a significantly higher HRV representing less cardiac stress during the BAT in case of a successful reduction of anxiety symptoms at T1 (post/ shortly after treatment) and T2 (follow-up/ 6 months after treatment) compared to T0 (pre/ before treatment).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Würzburg, Germany, 97080
        • Recruiting
        • Department of Psychiatry, Psychosomatics, and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg
        • Contact:
          • Jürgen Deckert, Prof. Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Music performance anxiety (MPA)

    • Reporting anxiety and/or avoidance of musical performance situations
    • Reporting psychological distress and/or impaired functioning due to the MPA
  • Sufficient knowledge of the German language (to understand questionnaires and the therapy manual)
  • Compliance with the covid-19-regulations for local study appointments
  • Written informed consent

Exclusion Criteria:

  • Substance use disorder
  • Physiological contraindications for an exposure therapy (i.e. epilepsy, serious disorder of the cardiovascular system)
  • Psychological contraindications for an exposure therapy (i.e. psychotic disorder, substance dependence, borderline personality disorder, acute suicidality)
  • Use of sedative medication or tranquilizers (i.e. beta-blockers) for the therapy appointments
  • Claustrophobia
  • Blood-injection-injury type phobia
  • Instrument not portable, too big or not playable while standing (i.e. piano, drums, harp, double bass)
  • Not able to play the instrument blindfold
  • Current psychotherapy because of the MPA
  • Recent (< 6 months ago) psychotherapy because of the MPA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual Reality Exposure Therapy (VRET)
Behavioral: Virtual Reality Exposure Therapy (VRET)
Four VRET sessions of approx. one hour each session taking place in an individual setting accompanied by a therapist. The participants wear a head-mounted display showing different musical performance scenarios (i.e. audition in a concert hall/ recording studio/ in front of a professional jury/ an audience/ a class of music students) that are selected individually by a previously standardized, graded exposure procedure.
Active Comparator: Progressive Muscle Relaxation (PMR)
Behavioral: Progressive Muscle Relaxation (PMR)
Four PMR sessions of approx. 45min each session taking place in an individual setting accompanied by a therapist. The sessions follow a previously standardized procedure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
German Version of the Performance Anxiety Questionnaire (Fehm, 2002)
Time Frame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Measuring subjective MPA symptoms for solo and ensemble performances by assessing the total score for the scale solo performance (0-80) and the total score for the scale ensemble performance (0-80). Higher scores indicate more symptoms of music performance anxiety.
Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Heart rate variability
Time Frame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Measuring the cardiac reactivity throughout the BAT in virtual reality
Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective Units of Distress (SUDs) during the BAT
Time Frame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Measuring subjective MPA (0-100) in the BAT in virtual reality. Higher scores indicate a higher level of anxiety.
Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Social Interaction Anxiety Scale (SIAS)
Time Frame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Measuring symptoms of social anxiety or distress specifically when talking or meeting others. A higher total score (0-80) indicates more symptoms of social anxiety.
Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Social Phobia Scale (SPS)
Time Frame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Measuring symptoms of social phobia specifically in anticipation of or when actually being observed by others and when engaging in activities in the presence of others. A higher total score (0-80) indicates more symptoms of social anxiety.
Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Beck Depression Inventory (BDI-II)
Time Frame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Measuring symptoms of depression. A higher total score (0-63) indicates more symptoms of depression.
Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Beck Anxiety Inventory (BAI)
Time Frame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Measuring symptoms of anxiety. A higher total score (0-63) indicates more symptoms of anxiety.
Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Anxiety Sensitivity Index (ASI-3)
Time Frame: Only one assessment at T0 (pre/ before treatment)
Measuring anxiety sensitivity. A higher total score (0-56) indicates a higher level of anxiety sensitivity.
Only one assessment at T0 (pre/ before treatment)
State Trait Anxiety Inventory - Trait (STAI-Trait)
Time Frame: Only one assessment at T0 (pre/ before treatment)
Measuring trait anxiety. A higher total score (20-80) indicates a higher level of trait anxiety.
Only one assessment at T0 (pre/ before treatment)
Childhood Trauma Questionnaire (CTQ)
Time Frame: Only one assessment at T0 (pre/ before treatment)
Measuring childhood-history of abuse and neglect by assessing the total scores for the scales Emotional Neglect (7-35), Sexual Abuse (5-25), Physical Abuse and Neglect (7-35), and Emotional Abuse (5-25). Higher Scores indicate a higher level of childhood abuse and/or neglect.
Only one assessment at T0 (pre/ before treatment)
Immersive Tendencies Questionnaire (ITQ)
Time Frame: Only one assessment at T0 (pre/ before treatment)
Measuring immersive tendencies. Higher scores on the scales Focus (5-35), Implication (5-25), Emotion (4-28), Joy (3-31) and a higher total score (17-119) indicate a higher level of immersive tendencies.
Only one assessment at T0 (pre/ before treatment)
Uncertainty Tolerance Scale (UGTS)
Time Frame: Only one assessment at T0 (pre/ before treatment)
Measuring uncertainty tolerance. A higher total score (8-48) indicates a higher level of uncertainty tolerance.
Only one assessment at T0 (pre/ before treatment)
Positive and Negative Affect Schedule (PANAS)
Time Frame: Change from before to after (approx. 45min later) the BAT in VR at T0 (pre/ before treatment), T1 (post/ approx. one week after treatment) and T2 (follow-up/ 6 months after treatment)
Measuring state affect. Higher scores on the scales Positive Affect (10-50) and Negative Affect (10-50) indicate a higher level of positive or negative state affect.
Change from before to after (approx. 45min later) the BAT in VR at T0 (pre/ before treatment), T1 (post/ approx. one week after treatment) and T2 (follow-up/ 6 months after treatment)
Blood pressure
Time Frame: Change from before to after (approx. 30min later) the BAT in VR at T0, T1 and T2; and changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Measuring cardiac stress
Change from before to after (approx. 30min later) the BAT in VR at T0, T1 and T2; and changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Heart rate
Time Frame: Change from before to after (approx. 30min later) the BAT in VR at T0, T1 and T2; and changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Measuring cardiac stress
Change from before to after (approx. 30min later) the BAT in VR at T0, T1 and T2; and changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Salivary cortisol hormone
Time Frame: Change from before to after (approx. 30min later) the BAT in VR at T0, T1 and T2; and changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Measuring the psychophysiological stress response
Change from before to after (approx. 30min later) the BAT in VR at T0, T1 and T2; and changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Neuropeptides
Time Frame: Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Analysis of neuropeptides with modulating effects on humoral and behavioral stress response, and myocardial as well as autonomic nerve system function, such as Atrial natriuretic Polypeptide (ANP), neuropeptide Y (NPY), Oxytocin (OCT), salivary Alpha-Amylase (sAA).
Changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Epigenetic Targets
Time Frame: Change from before to after (approx. 30min later) the BAT in VR at T0, T1 and T2; and changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
mDNA analysis of the candidate genes related to the endocrine stress reactivity (NR3C1, FKBP5, CRHR1) and DNAm analysis of Norepinephrine Transporter (NET) and Oxytocin Receptor (OXTR) genes due to their implication in the regulation of autonomous function and social anxiety
Change from before to after (approx. 30min later) the BAT in VR at T0, T1 and T2; and changes from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Kenny Music Performance Anxiety Inventory-Revised (K-MPAI-R)
Time Frame: Change from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Measuring performance anxiety in musicians. A higher total score (0-240) indicates a higher level of music performance anxiety.
Change from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Questionnaire on safety- and avoidance behaviors for musicians (Mumm et al., 2020)
Time Frame: Change from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)
Measuring the use of safety and avoidance behaviors in musicians. A higher total score (0-215) indicates a higher use of safety- and avoidance behaviors to reduce anxiety in performance situations.
Change from T0 (pre/ before treatment) to T1 (post/ approx. one week after treatment) and from T0 (pre/ before treatment) to T2 (follow-up/ 6 months after treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuerzburg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 194/21-sc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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