Clinical trial NCT05441670: Art and Physical Therapy in Pediatric HCT
Official title: The Effect of a Collaborative Art Therapy and Physical Therapy Intervention on Children Undergoing a Hematopoietic Cell Transplant (HCT): a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Art Therapy
Physical Therapy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Endowment for the Arts, United States
First posted: 2022-07-01
Enrollment: 18
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the effect of a combination of art therapy (AT) and physical therapy (PT) to PT only in children undergoing hematopoietic cell transplant (HCT). Each child will receive daily AT and PT or only PT for 5 days per week for 2 weeks. These sessions will begin approximately on day 15 following the transplant. Prior to starting the sessions and following 2-weeks of sessions, self-care and mobility skills will be measured. During each session, the following variables will be measured: heart rate variability (i.e., time between heart beats) using a small monitor on the chest (about the size of a quarter), walking distance using an accelerometer (similar to wearing a watch), and self-reported happiness and excitability. Although results cannot be guaranteed, it is expected that each group will benefit and demonstrate improvements in emotional state, self-care, and mobility skills.

Detailed description: This quantitative randomized clinical trial will examine the effect of a collaborative art therapy (AT) and physical therapy (PT) intervention as compared to a PT only intervention in children undergoing a hematopoietic cell transplant. We hypothesize that physiological, emotional, selfcare, and mobility as measured by heart rate variability, Self-Assessment Manikin, walking distance and steps, and Pediatric Disability Inventory Computerized Adapted Test will demonstrate greater improvement for the AT and PT group as well as identify media that more effectively impact these physiological and health outcomes. Findings from this project may provide scientific evidence for increasing the uptake of AT and PT in children undergoing HCT.

Eligibility criteria: Inclusion Criteria:

* between ages 5 to 18
* Clinical Diagnosis of hematological disease
* Undergoing Hematopoietic Cell Transplantation (HCT)
* Within the inpatient hospital treatment phase of HCT

Exclusion Criteria:

* Less than age 5
* Older than age 18
* Central nervous system impairments (e.g., cerebral palsy)
* Genetic diseases (e.g., Down syndrome)
* Cognitive impairment

Primary outcomes:
measure: Changes in scaled scores of the Pediatric Evaluation of Disability Inventory - Computerized Adapted Test (PEDI-CAT)
timeFrame: Pre- and post- testing before and after the 10 day intervention. Pre-testing = Day before intervention (Day 0), Post-testing = Day after intervention completion (Day 11)
measure: Changes in walking distance on the 6-Minute Walk Test (6WMT)
timeFrame: Pre- and post- testing before and after the 10 day intervention. Baseline day before intervention (Day 0), Day after intervention completion (Day 11)
measure: Changes in the Self-Assessment Manikin (SAM)
timeFrame: Collected daily at the beginning and end of each treatment session over the 10-day intervention period. (Art and physical therapy group treatment duration = 75min, physical therapy group treatment duration = 30min)
measure: Change in values of Respiratory Sinus Arrhythmia (RSA) derived from Heart Rate Variability as captured by ECG
timeFrame: Collected daily with continuous monitoring throughout the duration of the treatment session over the 10-day intervention period. (Art and physical therapy group treatment duration = 75min, physical therapy group treatment duration = 30min)
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC Shawn Jenkin's Children's Hospital
state: South Carolina
Study officials:
affiliation: MUSC College of Health Professions
name: Cindy Dodds, PhD
role: PRINCIPAL_INVESTIGATOR
References: