Music Performance AnxietyNCT05735860
The Application of Virtual Reality Exposure Versus Relaxation Training in Music Performance Anxiety
A study testing Virtual Reality Exposure Therapy (VRET) and Progressive Muscle Relaxation (PMR) in people with Music Performance Anxiety, run by Wuerzburg University Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Music Performance Anxiety
- What is being tested?
- Virtual Reality Exposure Therapy (VRET) and Progressive Muscle Relaxation (PMR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jan 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Kristin Wehrmann, M. Sc. contact
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry, Psychosomatics, and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg
Würzburg, 97080
Jürgen Deckert, Prof. Dr. med.
About this study
Official title: 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).
- Conditions
- Music Performance Anxiety
- Being tested
- Virtual Reality Exposure Therapy (VRET), Progressive Muscle Relaxation (PMR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Exposure Therapy (VRET)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Exposure Therapy (VRET) | Experimental | Not described Receives: Behavioral: Virtual Reality Exposure Therapy (VRET) |
| Progressive Muscle Relaxation (PMR) | Active comparator | Not described Receives: Behavioral: Progressive Muscle Relaxation (PMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measuring the cardiac reactivity throughout the BAT in virtual reality
Measured: 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 outcomes (18)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Measuring symptoms of depression. A higher total score (0-63) indicates more symptoms of depression.
Measured: 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)
Measuring symptoms of anxiety. A higher total score (0-63) indicates more symptoms of anxiety.
Measured: 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)
Measuring anxiety sensitivity. A higher total score (0-56) indicates a higher level of anxiety sensitivity.
Measured: Only one assessment at T0 (pre/ before treatment)
State Trait Anxiety Inventory - Trait (STAI-Trait)
Measuring trait anxiety. A higher total score (20-80) indicates a higher level of trait anxiety.
Measured: Only one assessment at T0 (pre/ before treatment)
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.
Measured: Only one assessment at T0 (pre/ before treatment)
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.
Measured: Only one assessment at T0 (pre/ before treatment)
Uncertainty Tolerance Scale (UGTS)
Measuring uncertainty tolerance. A higher total score (8-48) indicates a higher level of uncertainty tolerance.
Measured: Only one assessment at T0 (pre/ before treatment)
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.
Measured: 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
Measuring cardiac stress
Measured: 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
Measuring cardiac stress
Measured: 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
Measuring the psychophysiological stress response
Measured: 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
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).
Measured: 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
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
Measured: 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)
Measuring performance anxiety in musicians. A higher total score (0-240) indicates a higher level of music performance anxiety.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start11 Jan 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Music Performance AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled / two-arm parallel assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735860
- Sponsor's protocol ID
- 194/21-sc
- Status last verified
- Feb 2023
- First submitted
- 14 Dec 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37528410
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Die Nutzung Virtueller Realität Zur Behandlung Von Auftrittsangst
- ClinicalTrials.gov ID
- NCT05735860
- Acronym / sponsor ID
- 194/21-sc
- Conditions
- Music Performance Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled / two-arm parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Exposure Therapy (VRET) | Experimental | Behavioral: Virtual Reality Exposure Therapy (VRET) |
| Progressive Muscle Relaxation (PMR) | Active comparator | Behavioral: Progressive Muscle Relaxation (PMR) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Music performance anxiety (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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Virtual Reality Exposure Therapy (VRET) |
| 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. | Behavioural | Progressive Muscle Relaxation (PMR) |
Primary outcome
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.
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
18 secondary outcomes
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)
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)
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)
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)
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)
Anxiety Sensitivity Index (ASI-3)
Time frame: 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)
Childhood Trauma Questionnaire (CTQ)
Time frame: Only one assessment at T0 (pre/ before treatment)
Immersive Tendencies Questionnaire (ITQ)
Time frame: Only one assessment at T0 (pre/ before treatment)
Uncertainty Tolerance Scale (UGTS)
Time frame: 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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 37528410Bellinger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Wehrmann, M. Sc. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Exposure Therapy (VRET) and Progressive Muscle Relaxation (PMR) in people with Music Performance Anxiety, run by Wuerzburg University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Bellinger, Dr. med. (0931/201-76345, Bellinger_D@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05735860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.