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).
Age range
10 Years – 18 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Tinnitus Functional Index (TFI)
Timeframe: 2 weeks
Amsterdam Misophonia Scale (A-MIS-S)
Timeframe: 2 weeks
Pediatric Quality of Life PedQL)
Timeframe: 2 weeks
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Timeframe: 2 weeks
Short Mood and Feelings Questionnaire (SMFQ)
Timeframe: 2 weeks
Tinnitus Functional Index (TFI)
Timeframe: 4 weeka
Amsterdam Misophonia Scale (A-MIS-S)
Timeframe: 4 weeks
Pediatric Quality of Life PedQL)
Timeframe: 4 weeks
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Timeframe: 4 weeks
Short Mood and Feelings Questionnaire (SMFQ)
Timeframe: 4 weeks