Dysautonomia, Dysautonomia Like Disorder
Conditions
Keywords
Dysautonomia, Pilot Projects, Pediatrics, Complementary Therapies
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Life University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* 5-14 years of age * Baseline PASS score ≥20
Exclusion criteria
* History of epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of enrollees who are eligible to participate | 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 surveys completed | 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 participants adhering to the care plan | 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 | 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'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pediatric Autonomic Symptom Scales (PASS) scores | Baseline; ~4 weeks; ~8 weeks; ~12 weeks | Change in PASS scores from baseline. The PASS is validated 80-item parent-report questionnaire designed to assess autonomic function in children across four main subscales: 1) mood, behavior, and emotion; 2) secretomotor/sensory integration; 3) urinary/gastrointestinal systems; 4) circulation, thermoregulation, sleep, and breathing. PASS total scores can range from 0 (no autonomic symptoms) to 80 (severe dysautonomia). |
| Change in Short Sensory Profile (SSP) scores | Baseline; ~4 weeks; ~8 weeks; ~12 weeks | Change in SSP scores from baseline. The SSP is a validated 38-item parent-report designed to assess a child's responsiveness to sensory stimuli including tactile sensitivity, taste/smell sensitivity, and visual/auditory sensitivity. SSP total scores can range from 38 (extreme sensitivity) to 190 (no sensitivity). |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORTyson Perez, DC, PhD
Life University
Outcome results
None listed