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

Not Applicable

Not yet recruiting

• Conditions: Misophonia; Tinnitus
• Interventions: Other: Aurora Mindfulness app versus sham

• Registration Number: NCT06493825
• Lead Sponsor: University of Colorado, Denver

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 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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10
• Study Start: 2024-07-15
• Primary Completion: 2025-02-15
• Study Completion: 2025-02-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Aurora Mindfulness app versus sham	Subjects will undergo 2 weeks of immersive virtual reality exposure using the Aurora Mindfulness sham app (Invincikids) delivered using a Meta Quest 2 headset at the frequency of 10 minutes per session, 5 days out of a 7-day week. Subjects will undergo baseline and 2-week measurement of symptoms using 5 validated instruments.
Experimental	Aurora Mindfulness app versus sham	Subjects will undergo 4 weeks of immersive virtual reality exposure using the Aurora Mindfulness app (Invincikids) delivered using a Meta Quest 2 headset at the frequency of 10 minutes per session, 5 days out of a 7-day week. Subjects will undergo baseline, 2-week and 4-week measurement of symptoms using 5 validated instruments.

Primary Outcome Measures

Name	Time	Method
Pediatric Quality of Life PedQL)	4 weeks	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.
Screen for Child Anxiety Related Emotional Disorders (SCARED)	4 weeks	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.
Tinnitus Functional Index (TFI)	4 weeka	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.
Amsterdam Misophonia Scale (A-MIS-S)	4 weeks	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.
Short Mood and Feelings Questionnaire (SMFQ)	4 weeks	SMFQ measures depressive symptoms in children with a range of 0-26. The higher the score, the more depressive symptoms a child has.

Secondary Outcome Measures

Name	Time	Method
Satisfaction, acceptability and feasibility survey	4 weeks	The survey is in a 5-point Likert scale format with a range of very satisfied, satisfied, neutral, unsatisfied and very unsatisfied.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States