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

Primary Purpose

Music Performance Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Virtual Reality Exposure Therapy (VRET)
Progressive Muscle Relaxation (PMR)
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Music Performance Anxiety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry, Psychosomatics, and Psychotherapy, Center for Mental Health, University Hospital of WuerzburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality Exposure Therapy (VRET)

Progressive Muscle Relaxation (PMR)

Arm Description

Outcomes

Primary Outcome Measures

German Version of the Performance Anxiety Questionnaire (Fehm, 2002)
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.
Heart rate variability
Measuring the cardiac reactivity throughout the BAT in virtual reality

Secondary Outcome Measures

Subjective Units of Distress (SUDs) during the BAT
Measuring subjective MPA (0-100) in the BAT in virtual reality. Higher scores indicate a higher level of anxiety.
Social Interaction Anxiety Scale (SIAS)
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.
Social Phobia Scale (SPS)
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.
Beck Depression Inventory (BDI-II)
Measuring symptoms of depression. A higher total score (0-63) indicates more symptoms of depression.
Beck Anxiety Inventory (BAI)
Measuring symptoms of anxiety. A higher total score (0-63) indicates more symptoms of anxiety.
Anxiety Sensitivity Index (ASI-3)
Measuring anxiety sensitivity. A higher total score (0-56) indicates a higher level of anxiety sensitivity.
State Trait Anxiety Inventory - Trait (STAI-Trait)
Measuring trait anxiety. A higher total score (20-80) indicates a higher level of trait anxiety.
Childhood Trauma Questionnaire (CTQ)
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.
Immersive Tendencies Questionnaire (ITQ)
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.
Uncertainty Tolerance Scale (UGTS)
Measuring uncertainty tolerance. A higher total score (8-48) indicates a higher level of uncertainty tolerance.
Positive and Negative Affect Schedule (PANAS)
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.
Blood pressure
Measuring cardiac stress
Heart rate
Measuring cardiac stress
Salivary cortisol hormone
Measuring the psychophysiological stress response
Neuropeptides
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).
Epigenetic Targets
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
Kenny Music Performance Anxiety Inventory-Revised (K-MPAI-R)
Measuring performance anxiety in musicians. A higher total score (0-240) indicates a higher level of music performance anxiety.
Questionnaire on safety- and avoidance behaviors for musicians (Mumm et al., 2020)
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.

Full Information

First Posted
December 14, 2022
Last Updated
February 9, 2023
Sponsor
Wuerzburg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05735860
Brief Title
The Application of Virtual Reality Exposure Versus Relaxation Training in Music Performance Anxiety
Official Title
Die Nutzung Virtueller Realität Zur Behandlung Von Auftrittsangst
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuerzburg University Hospital

4. Oversight

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

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Music Performance Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled / two-arm parallel assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Exposure Therapy (VRET)
Arm Type
Experimental
Arm Title
Progressive Muscle Relaxation (PMR)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy (VRET)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation (PMR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
German Version of the Performance Anxiety Questionnaire (Fehm, 2002)
Description
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.
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)
Title
Heart rate variability
Description
Measuring the cardiac reactivity throughout the BAT in virtual reality
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)
Secondary Outcome Measure Information:
Title
Subjective Units of Distress (SUDs) during the BAT
Description
Measuring subjective MPA (0-100) in the BAT in virtual reality. Higher scores indicate a higher level of anxiety.
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)
Title
Social Interaction Anxiety Scale (SIAS)
Description
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.
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)
Title
Social Phobia Scale (SPS)
Description
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.
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)
Title
Beck Depression Inventory (BDI-II)
Description
Measuring symptoms of depression. A higher total score (0-63) indicates more symptoms of depression.
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)
Title
Beck Anxiety Inventory (BAI)
Description
Measuring symptoms of anxiety. A higher total score (0-63) indicates more symptoms of anxiety.
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)
Title
Anxiety Sensitivity Index (ASI-3)
Description
Measuring anxiety sensitivity. A higher total score (0-56) indicates a higher level of anxiety sensitivity.
Time Frame
Only one assessment at T0 (pre/ before treatment)
Title
State Trait Anxiety Inventory - Trait (STAI-Trait)
Description
Measuring trait anxiety. A higher total score (20-80) indicates a higher level of trait anxiety.
Time Frame
Only one assessment at T0 (pre/ before treatment)
Title
Childhood Trauma Questionnaire (CTQ)
Description
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.
Time Frame
Only one assessment at T0 (pre/ before treatment)
Title
Immersive Tendencies Questionnaire (ITQ)
Description
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.
Time Frame
Only one assessment at T0 (pre/ before treatment)
Title
Uncertainty Tolerance Scale (UGTS)
Description
Measuring uncertainty tolerance. A higher total score (8-48) indicates a higher level of uncertainty tolerance.
Time Frame
Only one assessment at T0 (pre/ before treatment)
Title
Positive and Negative Affect Schedule (PANAS)
Description
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.
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)
Title
Blood pressure
Description
Measuring cardiac stress
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)
Title
Heart rate
Description
Measuring cardiac stress
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)
Title
Salivary cortisol hormone
Description
Measuring the psychophysiological stress response
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)
Title
Neuropeptides
Description
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).
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)
Title
Epigenetic Targets
Description
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
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)
Title
Kenny Music Performance Anxiety Inventory-Revised (K-MPAI-R)
Description
Measuring performance anxiety in musicians. A higher total score (0-240) indicates a higher level of music performance anxiety.
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)
Title
Questionnaire on safety- and avoidance behaviors for musicians (Mumm et al., 2020)
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Bellinger, Dr. med.
Phone
0931/201-76345
Email
Bellinger_D@ukw.de
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Wehrmann, M. Sc.
Email
wehrmann_K2@ukw.de
Facility Information:
Facility Name
Department of Psychiatry, Psychosomatics, and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jürgen Deckert, Prof. Dr. med.

12. IPD Sharing Statement

Learn more about this trial

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

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