Die Nutzung Virtueller Realität Zur Behandlung Von Auftrittsangst
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- German Version of the Performance Anxiety Questionnaire (Fehm, 2002)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
German Version of the Performance Anxiety Questionnaire (Fehm, 2002)
时间窗: 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.
Heart rate variability
时间窗: 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
次要结局
- Anxiety Sensitivity Index (ASI-3)(Only one assessment at T0 (pre/ before treatment))
- Social Interaction Anxiety Scale (SIAS)(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)(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))
- Childhood Trauma Questionnaire (CTQ)(Only one assessment at T0 (pre/ before treatment))
- Immersive Tendencies Questionnaire (ITQ)(Only one assessment at T0 (pre/ before treatment))
- Uncertainty Tolerance Scale (UGTS)(Only one assessment at T0 (pre/ before treatment))
- Positive and Negative Affect Schedule (PANAS)(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))
- Beck Depression Inventory (BDI-II)(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(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))
- Epigenetic Targets(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))
- Subjective Units of Distress (SUDs) during the BAT(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))
- Questionnaire on safety- and avoidance behaviors for musicians (Mumm et al., 2020)(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))
- Beck Anxiety Inventory (BAI)(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))
- State Trait Anxiety Inventory - Trait (STAI-Trait)(Only one assessment at T0 (pre/ before treatment))
- Blood pressure(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(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(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)(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))