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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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'. | 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' | 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' | 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'. | From enrollment to the end of the 12 week study period |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Tyson Perez, DC, PhD | Life University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrated Holistic Wellness | Madina Town | Fsisalabad | 38000 | Pakistan |
Deidentified IPD necessary to reproduce results
(start date): within 1 year of study completion. (end date): indefinitely
IPD, metadata & analytic code necessary to reproduce results will be made publicly accessible via a data repository
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| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| C535728 | Dysautonomia like disorder |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| Baseline; ~4 weeks; ~8 weeks; ~12 weeks |
| 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). | Baseline; ~4 weeks; ~8 weeks; ~12 weeks |