Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05748808
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-01-19
Brief Title:
Use of Biofeedback and Virtual Reality as Facilitators of Emotional Recognition in the Treatment of Aggressive Outbursts
Sponsor:
University of Seville
Organization:
University of Seville
Study Overview
Official Title:
Use of Biofeedback and Virtual Reality as Facilitators of Emotional Recognition in the Treatment of Aggressive Outbursts
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BReTIA
Brief Summary:
The methodology will be applied for the treatment of aggressive episodes Many people show this kind of behavior associated with several psychological disorders like austistic spectrum disorder ASD It will be studied the effect of aggressive outbursts on several physiological signals heart rate HR breathing rate BR electroencephalography EEG etc The use of those signals in a biofeedback loop could help patients recognize their internal states and avoid imminent aggression The study want to verify the efficacy of a cognitive therapy that includes biofeedback and virtual reality VR and find out the most significant physiological features that are affected by these episodes
Detailed Description:
The first goal is to register the scene together with physiological values before during and after at least up to four aggressive outbursts at home
Next an outburst is induced and physiological signals before during and after the aggressive episode are recorded After it the participants go to a new relaxation phase for another 10-minute period using the VR
In following sessions they are trained to identify their physiological response when they are relaxed and when an outburst is coming To do that the VR system receives and shows the physiological information on the virtual scenario
In following sessions teenagers are then treated with cognitive behavioral and emotional self-regulation therapies which have proven their effectiveness for managing anger and learning positive coping skills The underlying theory is that people can minimize their negative feelings and behaviors when they are aware of their irrational beliefs and work to change their minds by focusing on them continuously
At the end of the experiment the number of aggressive episodes in the last weeks of the intervention will be measured
The differences between the new scores with respect to the initial ones will be used to assess the efficacy of the intervention
Next an outburst is induced and physiological signals before during and after the aggressive episode are recorded After it the participants go to a new relaxation phase for another 10-minute period using the VR
In following sessions they are trained to identify their physiological response when they are relaxed and when an outburst is coming To do that the VR system receives and shows the physiological information on the virtual scenario
In following sessions teenagers are then treated with cognitive behavioral and emotional self-regulation therapies which have proven their effectiveness for managing anger and learning positive coping skills The underlying theory is that people can minimize their negative feelings and behaviors when they are aware of their irrational beliefs and work to change their minds by focusing on them continuously
At the end of the experiment the number of aggressive episodes in the last weeks of the intervention will be measured
The differences between the new scores with respect to the initial ones will be used to assess the efficacy of the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None