Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aurora Mindfulness app versus sham.
- Who it may be relevant to
- Registry conditions: Tinnitus, Misophonia. Basic parameters: 10 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Detailed description
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).
The primary outcome measures are the changes ot the pre-entry and post-entry scores of the 5 validated instruments at 2 weeks post-entry. In the experimental group, dose response will be measured between the 2- and 4-week results.
Interventions
- Other Aurora Mindfulness app versus sham
It would either immersive virtual reality exposure for the experimental group or non-immersive virtual reality exposure for the placebo group.
Primary outcome measures
- Tinnitus Functional Index (TFI) [Time frame: 2 weeks]
- Amsterdam Misophonia Scale (A-MIS-S) [Time frame: 2 weeks]
- Pediatric Quality of Life PedQL) [Time frame: 2 weeks]
- Screen for Child Anxiety Related Emotional Disorders (SCARED) [Time frame: 2 weeks]
- Short Mood and Feelings Questionnaire (SMFQ) [Time frame: 2 weeks]
- Tinnitus Functional Index (TFI) [Time frame: 4 weeka]
- Amsterdam Misophonia Scale (A-MIS-S) [Time frame: 4 weeks]
- Pediatric Quality of Life PedQL) [Time frame: 4 weeks]
- Screen for Child Anxiety Related Emotional Disorders (SCARED) [Time frame: 4 weeks]
- Short Mood and Feelings Questionnaire (SMFQ) [Time frame: 4 weeks]
Secondary outcome measures (2)
- Satisfaction, acceptability and feasibility survey [Time frame: 2 weeks]
- Satisfaction, acceptability and feasibility survey [Time frame: 4 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Children's Hospital Colorado — Aurora
Identifiers
NCT: NCT06493825 · 24-0389