Ignite Creation Date:
2024-07-17 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493825
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Effects of Immersive Virtual Reality Mindfulness Application on Quality of Life Anxiety and Depression Symptoms in Children With Severe Tinnitus and Misophonia - A Pilot Study
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Effects of Immersive Virtual Reality Mindfulness Application on Quality of Life Anxiety and Depression Symptoms in Children With Severe Tinnitus and Misophonia - A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Children with bothersome tinnitus and misophonia have elevated anxiety and depression symptoms The mainstay therapy for adults and children with these disorders is cognitive behavioral therapy CBT CBT resources are expensive and scarce for the pediatric population Immersive virtual reality IVR has been shown in the adult population to be a proxy for CBT for several mental health disorders There is sufficient published evidence that IVR is useful in treating adults with anxiety and depression disorders However the evidence in children in treating either anxiety and depression symptoms or disorder is scant Our group views IVR application as a promising medical device to decrease anxiety and depression scores in children with tinnitus and misophonia disorders
This is a randomized placebo control single-blinded to the study subjects study in which there will be a 21 ratio between the experimental and placebo subjects receiving either active IVR or placebo exposure A total of 30 subjects with 20 experimental 10 tinnitus 10 misophonia subjects and 10 placebo 5 tinnitus and 5 misophonia subjects will enroll in this randomized clinical trial Assessment of change of quality of life anxiety and depression symptoms will be based on 5 validated instruments
The 5 validated instruments are Tinnitus Functional Index TFI Amsterdam Misophonia Scale A-MIS-S Pediatric Quality of Life PEDQL Screen for Child Anxiety Related Emotional Disorders SCARED and Short Mood and Feelings Questionnaire SMFQ
This is a randomized placebo control single-blinded to the study subjects study in which there will be a 21 ratio between the experimental and placebo subjects receiving either active IVR or placebo exposure A total of 30 subjects with 20 experimental 10 tinnitus 10 misophonia subjects and 10 placebo 5 tinnitus and 5 misophonia subjects will enroll in this randomized clinical trial Assessment of change of quality of life anxiety and depression symptoms will be based on 5 validated instruments
The 5 validated instruments are Tinnitus Functional Index TFI Amsterdam Misophonia Scale A-MIS-S Pediatric Quality of Life PEDQL Screen for Child Anxiety Related Emotional Disorders SCARED and Short Mood and Feelings Questionnaire SMFQ
Detailed Description:
None
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