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.
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.
Study Type
OBSERVATIONAL
Enrollment
20
Integrated Holistic Wellness
Madina Town, Fsisalabad, Pakistan
Proportion of enrollees who are eligible to participate
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'.
Time frame: From enrollment to baseline PASS submission (up to 48-hours)
Proportion of participants complying with instructions
The number of participants submitting online surveys within the 48-hour submission window, divided by the total number of participants. This assesses 'Compliance'
Time frame: From enrollment to the end of participation (up to 12 weeks)
Proportion of participants adhering to the care plan
The number of participants attending ≥90% of scheduled remote sessions with their CIH practitioner, divided by the total number of participants. This assesses 'Adherence'
Time frame: From enrollment to the end of participation (up to 12 weeks)
Proportion of participants retained in the study
The number of participants submitting the 4th and final online surveys, divided by the total number of participants. This assesses 'Retention'.
Time frame: From enrollment to the end of the 12 week study period
Change in Pediatric Autonomic Symptom Scales (PASS) scores
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).
Time frame: Baseline; ~4 weeks; ~8 weeks; ~12 weeks
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Change in Short Sensory Profile (SSP) scores
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).
Time frame: Baseline; ~4 weeks; ~8 weeks; ~12 weeks