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
NCT Number: NCT06493825
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tinnitus|Misophonia
Interventions: OTHER: Aurora Mindfulness app versus sham
Sponsor: University of Colorado, Denver
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2025-02-15
Locations: Children's Hospital Colorado, Aurora, Colorado, 80218, United States

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 2:1 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).

Primary Outcome Measures: Tinnitus Functional Index (TFI), TFI measures the severity of tinnitus symptoms across several domains with a score range 0 to 90. The higher the score, the more dysfunction a subject is affected by tinnitus., 2 weeks|Amsterdam Misophonia Scale (A-MIS-S), A-MIS-S measures the severity of misophonia symptoms across several domains with a score range of 0-24. The higher the score, the more dysfunction a subject is affected by misophonia., 2 weeks|Pediatric Quality of Life PedQL), PedQL measures health-related quality of life of children with a range of 0 -100. The higher the score, the worse the health-related quality of life is., 2 weeks|Screen for Child Anxiety Related Emotional Disorders (SCARED), SCARED screens for anxiety disorder in children and it ranges from 0-82. The higher the score, the higher the likelihood a child might have an anxiety disorder., 2 weeks|Short Mood and Feelings Questionnaire (SMFQ), SMFQ measures depressive symptoms in children with a range of 0-26. The higher the score, the more depressive symptoms a child has., 2 weeks|Tinnitus Functional Index (TFI), TFI measures the severity of tinnitus symptoms across several domains with a score range 0 to 90. The higher the score, the more dysfunction a subject is affected by tinnitus., 4 weeka|Amsterdam Misophonia Scale (A-MIS-S), A-MIS-S measures the severity of misophonia symptoms across several domains with a score range of 0-24. The higher the score, the more dysfunction a subject is affected by misophonia., 4 weeks|Pediatric Quality of Life PedQL), PedQL measures health-related quality of life of children with a range of 0 -100. The higher the score, the worse the health-related quality of life is., 4 weeks|Screen for Child Anxiety Related Emotional Disorders (SCARED), SCARED screens for anxiety disorder in children and it ranges from 0-82. The higher the score, the higher the likelihood a child might have an anxiety disorder., 4 weeks|Short Mood and Feelings Questionnaire (SMFQ), SMFQ measures depressive symptoms in children with a range of 0-26. The higher the score, the more depressive symptoms a child has., 4 weeks
Secondary Outcome Measures: Satisfaction, acceptability and feasibility survey, The survey is in a 5-point Likert scale format with a range of very satisfied, satisfied, neutral, unsatisfied and very unsatisfied., 2 weeks|Satisfaction, acceptability and feasibility survey, The survey is in a 5-point Likert scale format with a range of very satisfied, satisfied, neutral, unsatisfied and very unsatisfied., 4 weeks