This clinical trial compares the effect of combination art therapy (AT) and physical therapy (PT) to PT alone for improving functional, physiological, and emotional outcomes in children undergoing hematopoietic cell transplant (HCT). Anxiety, pain, loss of control, as well as reductions in physical conditioning, functional mobility, self care, and motor skills are common consequences associated with HCT in children with hematological disease. AT has been demonstrated to foster improvements in anxiety and pain that then promote greater compliance with medical treatments. PT across the continuum of HCT has shown to improve functional mobility, abilities of daily living, strength and endurance, and promotes a reintegration into everyday participation. The use of AT to help reduce emotional distress prior to PT could not only enhance PT compliance, but also provide greater opportunity for improvements in physical performance and overall health.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05441670.
PRIMARY OBJECTIVES:
I. In children undergoing HCT during in-patient care, does a randomized group receiving a combination of PT plus AT have improved functional activity level outcomes of selfcare and mobility as measured by the Pediatric Evaluation of Disability Inventory Computerized Adaptive Test (PEDI CAT) and the 6-Minute Walk Test (6MWT), compared with a group receiving PT only.
II. Do children receiving PT plus AT have different physiological (sympathetic or parasympathetic) and emotional responses to oil pastels and gouache as measured by respiratory sinus arrhythmia (RSA) derived from heart rate variability (HRV) and Self-Assessment Manikin (SAM) scores during each of the daily AT sessions.
III. In children receiving PT plus AT, determine if there is a stronger association between the RSA values of oil pastels or gouache AT and an increased walking distance as measured by accelerometry during daily PT sessions.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo collaborative AT over 45 minutes with oil pastels on days 1-5 and gouache painting on days 6-10 immediately followed by PT over 30 minutes daily Monday-Friday for 2 weeks.
ARM II: Patients undergo PT over 30 minutes daily Monday-Friday for 2 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMedical University of South Carolina
Principal InvestigatorCynthia Brown Dodds