Neuro-Emotional Release: Veins and Endocrine System (NERVE) Therapy for Children With Dysautonomia: a Pilot Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Proportion of participants adhering to the care plan
研究概览
简要总结
To investigate the feasibility of implementing an online assessment battery in tandem with normal & customary complementary & integrative healthcare (CIH) provided to children with dysautonomia. The secondary aim is to assess the potential impacts of CIH on clinical outcomes.
详细描述
The main aim of this pilot observational study is to investigate the feasibility of implementing an online assessment battery in tandem with normal & customary, fee-for-service, remotely delivered complementary & integrative healthcare (CIH, i.e., Neuro-Emotional Release: Veins & Endocrine System [NERVE] therapy) provided to children with significant parent-reported symptoms of dysautonomia. The primary outcomes are 1) eligibility, 2) compliance, 3) adherence, and 4) retention. A secondary/exploratory aim is to assess the potential clinical impacts of CIH via a validated parent-reported outcome measure (i.e., Pediatric Autonomic Symptom Scales, PASS; Short Sensory Profile, SSP). Data from this study will inform the feasibility of a definitive study powered to assess the effectiveness of NERVE therapy on clinical outcomes in a pediatric population with symptoms of dysautonomia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5-14 years of age
- •Baseline PASS score ≥20
排除标准
- •History of epilepsy
研究组 & 干预措施
Children (5-12) with Dysautonomia
Children aged 5-14 years whose parents/caregivers identify the presence of symptoms associated with dysautonomia. A formal clinical diagnosis is not required for inclusion
结局指标
主要结局
Proportion of participants adhering to the care plan
时间窗: From enrollment to the end of participation (up to 12 weeks)
The number of participants attending ≥90% of scheduled remote care sessions , divided by the total number of participants (excludes care sessions scheduled after withdrawal). This assesses 'Adherence'
Proportion of participants retained in the study
时间窗: From enrollment to the end of the 12 week study period
The number of eligible participants attending the final remote care session, divided by the total number of eligible participants. This assesses 'Retention'.
Proportion of surveys completed
时间窗: From enrollment to the end of participation (up to 12 weeks)
The number of online surveys submitted within the prespecified time window (72 hours), divided by the total number of online surveys distributed (excludes surveys scheduled after withdrawal). This assesses 'Compliance'
Proportion of enrollees who are eligible to participate
时间窗: From enrollment to baseline PASS submission (up to 48-hours)
The number of enrollees (i.e., participants who consent) who score ≥20 on the baseline Pediatric Autonomic Symptom Scales (PASS), divided by the total number of enrollees. This assesses 'Eligibility'.
Proportion of participants complying with instructions
时间窗: From enrollment to the end of participation (up to 12 weeks)
The number of participants submitting online surveys within the 48-hour submission window, divided by the total number of participants. This assesses 'Compliance'
次要结局
- Change in Pediatric Autonomic Symptom Scales (PASS) scores(Baseline; ~4 weeks; ~8 weeks; ~12 weeks)
- Change in Short Sensory Profile (SSP) scores(Baseline; ~4 weeks; ~8 weeks; ~12 weeks)
研究者
Tyson Perez, DC, PhD
Principal Investigator
Life University