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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pediatric Quality of Life PedQL)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Pediatric Quality of Life PedQL)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Satisfaction, acceptability and feasibility survey(4 weeks)