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

NCT ID: NCT05735860

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-11

Study Completion Date

2024-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Music Performance Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled / two-arm parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Virtual Reality Exposure Therapy (VRET)

Group Type EXPERIMENTAL

Virtual Reality Exposure Therapy (VRET)

Intervention Type BEHAVIORAL

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.

Progressive Muscle Relaxation (PMR)

Group Type ACTIVE_COMPARATOR

Progressive Muscle Relaxation (PMR)

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wuerzburg University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Würzburg, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Daniel Bellinger, Dr. med.

Role: CONTACT

0931/201-76345

Kristin Wehrmann, M. Sc.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jürgen Deckert, Prof. Dr. med.

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Bellinger D, Wehrmann K, Rohde A, Schuppert M, Stork S, Flohr-Jost M, Gall D, Pauli P, Deckert J, Herrmann MJ, Erhardt-Lehmann A. The application of virtual reality exposure versus relaxation training in music performance anxiety: a randomized controlled study. BMC Psychiatry. 2023 Aug 1;23(1):555. doi: 10.1186/s12888-023-05040-z.

Reference Type DERIVED
PMID: 37528410 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

194/21-sc

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Virtual Pain Care Trial
NCT05772468 ENROLLING_BY_INVITATION NA