Effects of a Mindfulness App on Mental Health in Children with Tinnitus and Misophonia
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
This study is testing if a virtual reality mindfulness app can help improve mental health for kids aged 10 to 18 who have severe tinnitus and misophonia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06493825 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of an immersive virtual reality mindfulness application on mental health symptoms in children aged 10 to 18 with severe tinnitus and misophonia. The study employs a randomized placebo-controlled design, where participants will be assigned to either the active IVR application or a placebo exposure in a 2:1 ratio. The effectiveness of the intervention will be assessed using five validated instruments that measure quality of life, anxiety, and depression symptoms. The goal is to determine if the IVR application can serve as an effective alternative to traditional cognitive behavioral therapy, which is often inaccessible for pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 10 to 18 years who exhibit severe symptoms of tinnitus and misophonia.
Not a fit: Patients with severe developmental delays, significant visual impairments, hearing loss, or a history of seizure disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel, accessible treatment option for children suffering from severe tinnitus and misophonia, potentially reducing their anxiety and depression symptoms.
How similar studies have performed: While immersive virtual reality has shown promise in treating anxiety and depression in adults, evidence in children is limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children between the ages of 10 to 18 years * All genders and ethnicities * Patients who meet criteria for "severe" symptoms of tinnitus and misophonia as scored by TIF and A-MISO-S Exclusion Criteria: * Severe developmental delay as not to understand verbal instructions necessary to complete the VR application/sham exposure. * Severe visual impairment (refractive disorders are acceptable) * Patients with unilateral or bilateral hearing loss of any type. * History of seizure disorder
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Kenny H Chan, MD
- Email: kenny.chan@childrenscolorado.org
- Phone: 720-777-8502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.