The Effect of a Collaborative Art Therapy and Physical Therapy Intervention on Children Undergoing a Hematopoietic Cell Transplant (HCT): a Randomized Clinical Trial
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation, Art Therapy, Physical Therapy
Sponsor: Medical University of South Carolina

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PROTOCOL TITLE: The effect of a collaborative art therapy and physical therapy intervention on 
children undergoing a hematopoietic cell transplant: a randomized clinical trial 
 
PRINCIPAL INVESTIGATOR: Cindy Dodds, PT, PhD, PCS 
 
Objectives / Specific Aims 
Aim 1: 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. 
Hypothesis 1: Children receiving the combined intervention of PT plus AT will demonstrate greater 
improvements in selfcare and mobility skills. 
 
Aim 2: 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.  
Hypothesis 2: Oil pastels or gouache AT will generate a greater RSA value in the direction of needed 
parasympathetic activity and balance in the emotions of valence, arousal, and dominance.  
 
Aim 3: 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.  
Hypothesis 3: The media that best generates a parasympathetic RSA value and emotional balance will be 
associated with a greater walking distance.   
 
2.0 
Background 
Overview: For the 13,000 children with hematological disease undergoing allogeneic hematopoietic cell 
transplant (HCT) in the United States1, art therapy (AT) and physical therapy (PT) are prescribed at a rate 
of approximately 50%2 to minimize negative treatment consequences. Anxiety, pain, loss of control as 
well as reductions in physical conditioning, functional mobility, selfcare, and motor skills are common 
consequences associated with HCT in children and will inform this proposed research project’s outcomes 
and aims.3  
 
As we consider the impact of AT and PT on children undergoing HCT, the AT literature generally 
emphasizes AT’s effect on emotional health (e.g., pain, anxiety) and PT’s on physical health (e.g., 
mobility, selfcare). The Model of Art Therapy in Management of Pediatric Chronic Pain4,5 fosters 
improvements in anxiety and pain following AT that then promote greater compliance with medical 
treatments.4,5 (Appendix 1). It is this theoretical premise that supports our proposed project’s suggestion 
that a collaborative treatment of AT and PT would be more effective than only providing AT or PT or 
providing both independent of each other. We believe the interconnected use of AT to reduce emotional 
distress prior to PT would not only enhance PT compliance, but also provide greater opportunity for 
improvements in physical performance and overall health.  
 
Art Therapy Evidence in Pediatric HCT   
The American Art Therapy Association (AATA) defines AT as an integrative mental health and human 
services profession that enriches the lives of individuals, families, and communities through active art-

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making, creative process, applied psychological theory, and human experience within a psychotherapeutic 
relationship.6 This AT process involves three important components: 1) patient, 2) art therapist, and 3) art 
making materials that interact collectively to impact emotional and health outcomes. In a 2019 review 
entitled Effectiveness of Art Therapy with Pediatric Populations Affected by Medical Health Conditions: 
A Systematic Review, Clapp acknowledges that the goals of AT interventions focused on enhancing 
emotional understanding and promoting symptom management.5 Similarly, yet specific to pediatric 
oncologic health conditions, the efficacy for AT is drawn from descriptive qualitative studies that support: 
1) emotional communication in response to anxiety, fear of death, loss of control, 2) a strategy by which 
to distract and/or cope, and 3) symptoms, anxiety, and pain amelioration.7,8 It is clearly stated in this 
systematic review that the majority of AT research findings are based on qualitative methods and, 
although this qualitative work is informative and guiding, the need to objectively quantify the 
effectiveness of AT and its impact on health outcomes has been noted and acknowledged within the 
literature.9 In fact, direct calls for more robust studies to examine AT’s impact on health outcomes have 
been documented5,10 and are necessary, not only to increase the uptake of AT in children undergoing 
HCT, but other pediatric populations as well. 
 
Physical Therapy in Pediatric HCT 
The American Physical Therapy Association defines physical therapy as the promotion, maintenance, and 
restoration of health through physical examination, diagnosis, prognosis, patient education, physical 
intervention, rehabilitation, disease prevention and health promotion.11 Physical therapists are consider 
movement experts11 and address illnesses or injuries that interfere with individuals’ ability to move and 
perform functional activities in their daily lives such a mobility and selfcare. The efficacy of physical 
therapy interventions using a variety of therapeutic exercise in pediatric populations has been well 
demonstrated in children with juvenile idiopathic arthritis12, having chronic pain13, and with hemiparetic 
cerebral palsy.14,15 Although efficacy is not yet supported, the implementation of exercise programming 
by physical therapists in the area of pediatric HCT is becoming more common to mitigate deconditioning 
and functional losses during the treatment course.16,17 For the children who receive PT, evidence 
indicates that exercise interventions across the continuum of HCT improve functional mobility, abilities 
of daily living, strength and endurance17, and promotes a reintegration into everyday participation. Yet in 
spike of these positive gains, prolonged motor delays following HCT remain common.18-25  
 
While a few PT studies have incorporated the use of emotional wellbeing education into exercise 
interventions to improve strength and endurance in patients during HCT17,26, in the reality of clinical 
settings where HCT take place, the primary focus of PT is therapeutic exercise and activities geared 
toward physical health. Knowing that emotional health is as important as physical health and with 
evidence of AT’s positive impact on emotional health for children undergoing HCT, it seems logical that 
collaborative interventions incorporating AT and PT would boost health outcomes. As such, we broadly 
hypothesize that children undergoing HCT in an in-patient setting receiving AT immediately prior to PT 
will display greater improvement in the body function (i.e., physiologic and emotional) and activity level 
(i.e., mobility and selfcare) outcomes across the International Classification of Functioning, Disability and 
Health27 (Appendix 2) than children only receiving PT. By exploring this broad hypothesis, we create an 
excellent opportunity to also investigate in greater depth the impact of AT media on body function and 
activity level outcomes.  
 
Motivation 1: Innovative use of quantifiable RSA/HRV to examine the impact of art therapy on the 
Autonomic Nervous System (ANS) in children undergoing HCT.  
Our first motivation for this research is believing that AT can physiologically improve the state of the 
ANS which can lead to better health outcomes for children with health conditions and disability and 
specific to this proposed study- children undergoing HCT. The Children’s Hospital at MUSC has an 
active in-patient HCT program and for that reason, we have an opportunity and are proposing that the use 

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a collaborative treatment of AT and PT, as compared to PT only, will improve mobility and selfcare 
outcomes in children undergoing HCT. Because of emotional impairments (i.e., pain and anxiety) that are 
associated with hematopoietic disease and HCT in children28, the ANS demonstrates a dominance toward 
fight or flight or unstable homeostasis.29,30  
 
To better understand this ANS dysfunction, a basic review is provided. The ANS consists of two systems: 
sympathetic (SNS) and parasympathetic nervous systems (PNS) that shape vagal tone by exerting 
influence upon the vagus nerve. The SNS creates a fight or flight state while the PNS fosters a rest and 
digest condition. Homeostasis is created when the two systems work in unison to create balanced vagal 
tone upon the vagal nerve. Intrinsic (e.g., hydration, body temperature) and extrinsic factors (e.g., bone 
marrow biopsy, chemotherapy treatment) can facilitate or interrupt this homeostasis. It is important to 
recognize that the although the SNS and PNS are interconnected, the SNS provides dominant and steady 
stimulation to the vagus nerve while the PNS providing ongoing, yet variable, braking to the SNS. It is 
this relationship that promotes either homeostatic stability or instability as intrinsic and extrinsic factors 
demand.  
 
Porges’ Polyvagal theory31 provides a more in depth understanding of the relationship between vagal 
tone and ANS. He proposes that 3 phylogenetic stages exist within the human ANS that are ordered to 
allow for 1) social communication, 2) mobilization or fight-flight, and 3) dissociation or immobilization. 
(Appendix 3.) Activation of the myelinated ventral vagus, in which the SNS and PNS are providing 
stimulation and braking to the vagal nerve, allows for homeostasis and social communication. This is the 
desired and more healthy state for human beings including children undergoing HCT. When intrinsic or 
extrinsic factors trigger the SNS with vagal braking inhibited, sympathetic dominance or a fight-flight 
responses manifest. Because of medical interventions (extrinsic) as well as anxiety and pain (intrinsic), 
this is this stage in which most children having HCT dwell.29,30  
 
Respiratory sinus arrhythmia is a direct measure of this vagal tone31 and is derived from HRV across the 
respiratory cycle. Heart rate variability is defined as the variation between consecutive heartbeats33 or 
beat to beat variability32. It is considered a validated physiological mechanism for evaluating the state of 
the ANS and more specifically emotional responsivity. In a systematic review, Kirizawa and colleagues29 
have advocated for the use of HRV as a physiological marker to evaluate ANS function in individuals 
with leukemia. The heart’s ability to demonstrate high variability is considered advantageous, but often 
undesirable intrinsic and extrinsic factors decrease variability. One such factor is the treatment of HCT in 
children with hematopoietic disease. Because RSA/vagal tone/HRV has been successfully used to 
investigate the ANS in pediatric traumatic brain injury34, premature babies35, and children with autism 
spectrum disorders36,37, we believe its use with children undergoing HCT in our study is promising. An 
additional advantage is the fact that the collection of RSA/HRV is non-invasive and improved 
technological development has led to the delivery of reliable, portable HRV monitors. Again, making its 
use appealing with children undergoing HCT.   
 
Motivation 2: Exploring the effect AT media on RSA/HRV, emotional state, and the health outcome of 
mobility in children undergoing HCT.   
Recognizing that AT and certain aspects of AT media have promoted changes in the ANS as measured by 
HRV in children and adults3, and that calls have been made for the use of HRV in studies exploring AT 
interventions5,9,10, we arrive at our second research motivation: to capture RSA/HRV during AT 
interventions in order determine if one type of media leads to improved changes in the ANS as captured 
by HRV/RSA, emotional ratings, and daily mobility.  
 
Understanding the relationship between patient, therapist, and the art making material is critical to 
generate effective patient outcomes. Much of the AT evidence discusses the important bond developed 

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between patient and therapist; however, awareness considering the qualities of the art making material has 
had limited examination. Despite the known interactive role of media through kinesthetic, tactile, 
perceptual, and symbolic input, media make play a more important than has previously been suggested. 
Kramer cleverly has described the media as the third hand, which contributes to an art therapist’s ability 
to steer the creative and restorative process.38,39 The Expressive Therapies Continuum (ETC) provides a 
conceptual model with developmental hierarchical levels that guide the assessment and application of art 
making materials during art therapy. (Appendix 4). It consisted of four levels: 
1) kinesthetic/sensory: sensory motor experience gained through the body’s interaction with the material   
2) perceptual/affective: emotional connection established by interaction with materials and creation of 
form/product  
3) cognitive/symbolic: emergence of symbolic or abstract thought centered about the product/form 
allowing for sophisticated, formative thought  
4) creative: communication or expressive interaction between the individual and the product/form 
promoting personal well-being whether by providing closure to a false sense of self or elation to 
restoration of an authentic sense of self.40-43  
These levels often interactive or overlap, but advancing through each of these levels over one art therapy 
session may not be achieved. This is especially the true for creative, the highest level.43  
 
Art therapy literature provides some degree of prescription for the use of specific media. Across an 
ordinal scale and based on fluidity, rankings for media from least to most emotionally engaging are 
pencils, oil pastels, and gouache.39 The use of markers and pencils is said to offer structure, control, and a 
limited emotional response that does not generate anxiety. Oil pastels or chalk are noted to afford 
moderate fluidity and tactical enrichment through touching and smearing, thereby resulting in greater 
emotional arousal (moderate anxiety) than pencils.42,44 When not using a brush, the fluidity offered by 
gouache painting yields high levels of emotional engagement and anxiety; however, use of a brush 
decreases emotional engagement. It is important to consider that gouache painting has also being 
described as liberating.45,46  
 
As has been encouraged by AT literature and organizations, several studies have examined the impact of 
media. The first study looked at media’s impact on the outcome of emotional responses and the second on 
HRV. Pesso-Aviv and colleagues explored the effects of pencils, oil chalks, and gouache paint on anxiety 
and self-control using survey data on 41 males between the ages of 7 to 9 years, who although not 
reported within the narrative appear to have been healthy, typically developing youth. Ten intervention 
session were provided for each of the three different media groups. Surprisingly, the results indicated no 
change in anxiety and self-control outcomes. This may be possibly explained by the youth being healthy 
and typically developing with little to no impairments in anxiety and self-control, thus, creating a ceiling 
effect with little space for documenting improvement. For children undergoing HCT, we know that 
emotional engagement and anxiety are problematic so media’s impact may be more detectable in this 
group. In the second study, Haiblum-Itskovitch and researchers hypothesized that emotional and ANS 
responses as measured by RSA/HRV values would be more reflective of PNS activity as fluidity of the 
media decreases in a normative sample of adult participants; thus, pencils would offer the greatest PNS 
activity followed by oil pastel and then gouache with brush. Surprisingly, results indicated that oil pastels 
resulted in the greater PNS activation than gouache while also corresponded to more meaningful 
emotional engagement. Thirty-five percent of the variance in the PNS value was explained by the media 
with a change in the RSA value of 1 representing the effect size needed for detecting a meaningful 
difference between materials. The author offered the possibility that the oil pastels facilitated greater 
tactile input which like fluidity may also played a role in ANS activity and emotional engagement. Based 
on the above information and considering that no study has explored the use of RSA/HRV as a 
physiological measure by which to evaluate a media’s impact on a population of children with a health 

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condition, our proposed study seeks to accomplish this by evaluating 2 media’s impact on physiological 
(RSA/HRV), emotional (SAM), and health outcomes (mobility) of in children undergoing HCT.   
 
 
3.0 
Intervention to be studied (if applicable) 
Side-by-side integration of AT and PT has not been examined and we propose to conduct a clinical trial in 
which for two weeks daily (Monday-Friday), 20 children between the ages of 3 5-18 years with be 
randomly assigned into one of two groups: 1) collaborative intervention: 45 minutes of AT immediately 
followed by 30 minutes of PT or 2) PT only intervention: 30 minutes. During the collaborative 
intervention of week 1, oil pastels will be the media and week 2 gouache painting without brush.  
 
Treatment: 45 minutes of AT closely followed by 30 minutes of PT OR 30 minutes of PT. 
 
AT treatments will seek to reduce sympathetic dominance/physiological and emotional distress. Oil 
pastels will be used for Days 1-5 and gouache painting for days 6-10. Art therapy is a collaborative, 
interactive, and iterative process that evolves across the session between the child and art therapist, as 
such, outside of the actual change in medium, there is no study specific art therapy prescription or 
protocol. Art therapy sessions will occur in the child’s room.  
 
PT treatments will seek to prevent physical deconditioning and encourage mobility, ambulation, and 
selfcare participation based on participant's ability. Physical therapy sessions will occur in the child’s 
room and on the HCT unit. 
 
The same art and physical therapist and art therapist will conduct children’s session across the 2-week 
study duration. This art and physical therapist commonly work on the HCT unit. The coordinator again 
will monitor all sessions to ensure the following of study procedures.  
 
4.0 
Study Endpoints (if applicable) 
Aim 1: Pre and post-test data collection, storage, and scoring calculations will be carried on by study 
coordinator/PhD student.   
Pediatric Evaluation of Disability Computerized Adaptive Test (PEDI CAT) using a study iPad: The 
PEDI CAT measures 0 to 18-year-old children’s abilities across three domains of mobility, selfcare and 
social function. It can be used with all pediatric diagnosis, across settings, and measures change following 
an intervention. It demonstrates excellent reliability48, good validity49,50 with a minimal detectable 
change ranging between 2.2 to 3.3 across domains.51 Our study will measure only selfcare and mobility 
domains, which takes approximately 20 minutes to administer. Scaled (criteria referenced) and Standard 
(normative referenced) PEDI-CAT scores will be calculated.    
 
6-Minute Walk Test (6MWT)  
The 6MWT has demonstrated good reliability and validity in various pediatric populations.52,53 It has 
also been found to be predictive of cardiovascular fitness in survivors of children with pediatric 
cancers.54 The 6MWT takes 6 minutes to administer.  
 
Aim 2: Daily data collection by art and physical therapists during or after sessions, but data will be 
managed by study coordinator/PhD student following the sessions. 
The Self-Assessment Manikin (SAM): The SAM is an image-based tool used to evaluate affective change 
in pleasure, arousal, and dominance in response to an object or event.55-57 (Appendix 6) Good reliability 
and validity of the SAM has been demonstrated.58 Suggestions are that it perform similarly across 
diverse cultures and ages.59-61 The SAM has been collected in studies involving exercise in which large 

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effect sizes were noted.62 We plan to use the computerized application of the SAM, which will take 
seconds to administer before and after daily AT and PT interventions.  
 
Respiratory Sinus Arrhythmia derived from Heart Rate Variability: HRV measures short-term R-to-R 
intervals, which is reflective of the autonomic nervous system. The portable, non-invasive Firstbeat 
Bodyguard 2 (Appendix 7) will be worn to gather HRV. The monitor will be placed on the chest of the 
child 10 minutes prior to the beginning of AT and worn by the child until removal following PT. We will 
evaluate the first and last 5-minute of HRV data during the AT session. Using Cardio Batch software, 
RSA will be calculated from the HRV data. The Firstbeat Bodyguard 2 accurately measures 99.95% of 
the heartbeats compared to standard EKG.63 Placement and removal of the HRV monitor requires only 
seconds. The study coordinator/PhD student will clean all HRV files for artifact and calculate RSA values 
using Cardio Batch software. At the end of each day, the coordinator/PhD student will be responsible for 
collecting, cleaning, scoring, and storing all daily data.  
 
Aim 3: Daily collection: Daily data collection by art and physical therapists during or after sessions, but 
data will be managed by study coordinator/PhD following the sessions. 
Walking distance during PT session as measured by accelerometer: The ActiGraph GT9X Link 
(Appendix 8) will collect walking distance as measures by distance and steps during PT. It is similar in 
looks and wear to an iWatch. It has demonstrated good reliability and validity.64,65 It can collect a 
variety of outcomes (e.g., energy expenditure, body position, sleep), but for aim 3, we will be most 
interested in walking distance and number of steps. At the end of each day, the study coordinator/PhD 
student will be responsible for collecting, calculating distance and step values using Actigraphy software, 
and storing accelerometry data.  
 
5.0 
Inclusion and Exclusion Criteria/ Study Population 
Inclusion criteria: Children between the ages of 4 and 18 years undergoing HCT in response to 
hematological disease during the in-patient hospital treatment phase.  
 
Exclusion criteria: Children with central nervous system impairments (e.g., cerebral palsy), other genetic 
diseases (e.g., Down syndrome), and cognitive impairment will be excluded from study participation. 
 
Children undergoing HCT were chosen as this study’s population because they often receive intermittent 
and stand-alone AT or PT. We believe more daily PT and/or AT as well as the collaboration between PT 
and AT will improve health outcomes. Because children display continual cognitive, behavior, and motor 
development changes, this study chose not to involve adults undergoing HCT. The outcomes for children 
and adults undergoing HCT cannot be validly compared. This study has no exclusions for any specific 
sex/gender or racial/ethnic group.  
 
6.0 
Number of Subjects 
20 
Approximately 30 children undergo HCT at MUSC Children’s Hospital annually for which 50% are male 
and female, 10% considered Hispanic, 55% Caucasian, and 35% African American. 
 
7.0 
Setting 
MUSC Shawn Jenkins Children’s Hospital. 
 
8.0 
Recruitment Methods 

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Participants will be recruited prior to and at the time of admission for the HCT. A flyer will be provider to 
the HCT team members to share with participants. Members of the HCT team will be made aware of the 
inclusion criteria and can approach all potential participants for possible study enrollment. While any 
team member may recruit a study participant, the study art therapist and physical therapist, who 
commonly associated with the HCT team, will especially be important for recruitment. In the majority of 
case, they are aware of dates that children will be transiting into the hospital for HCT. The study art 
therapist and physical therapist have a developed relation with the study PI. The art therapist and PI serve 
together as leaders within the MUSC Office of Humanities. The art therapist has also provided instruction 
within the PIs’ DPT and IP courses. The physical therapist is a graduate of the DPT program in which that 
the PI teaches. The physical therapist and PI have carried out national presentations together and the 
physical therapist also instructs within the PI’s courses. Participants and HCT team members will contact 
the PI when interest in enrollment is expressed. Parents will be welcome to contact the PI as well. The PI 
will contact parents of participants and seek informed consent and assent for study participation. 
 
9.0 
Consent Process 
Informed consent will be sought upon each child's admission to MUSC Shawn Jenkins Children's 
Hospital. It will occur approximately on or before Day 13 of the HCT. Day 14 will be for pre-testing and 
day 15 for start of intervention. Children's authorized representative will have at least 24 hours prior to 
study intervention initiation.  
 
Consent may be obtained in person at the hospital or using an electronic consent.  
 
For in person consents, the PI will obtain informed consent from parents or legal guardians at the MUSC 
Shawn Jenkins Children's Hospital. 
 
The PI will communicate by phone or email with the parent or legal guardian to establish a time to seek 
informed consent at the hospital OR discuss the use of an electronic consent.  If an electronic consent is 
used, the PI will email the consent to the parent or legal guardian using secure MUSC email. Then the PI 
will contact the parent or legal guardian by phone to review the informed consent and answer any 
questions. If the parent or legal guardian wishes to enroll in the study, they will sign the informed consent 
and return to the PI through the MUSC email system.  
 
Assent will be obtained from each individual child or adolescent at the same time that the informed 
consent is obtained from parents. If informed consent is carried out electronically, the parent will be asked 
to document the child or adolescent's assent using MUSC email communication.  
 
If a child withdraws assent prior to a study session, parents will be notified. If the child withdraws assent 
for a session for 3 days in a row, the child will be withdrawn from the study. If assent is less than 3 days, 
then missed days will be added to the study duration until 10 days are completed.  
 
10.0 Study Design / Methods 
Design: Randomized clinical trial to compare collaborative AT and PT to only PT in children undergoing 
HCT. 
 
Using excel, the study coordinator will randomize each participant to either the PT and AT or PT only 
group. Each group will be assigned 10 participants.  
 
 
Power  

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With a recruitment expectation of 30 participants, we expect a 30% drop out 
rate leaving 20 enrolled participants and feel confident that this study’s aim 2 and 3 
will be successfully power to identify statistical significance (p<0.05) in outcomes. For 
Aims 2 and 3 which involve the collection of clustered data for HRV, SAM, and 
walking distance, in order to identify a medium effect, 80% or 90% power will be 
achieved with 61 or 82 measurement points respectively.54,55,66,67 Accounting for 
a dropout rate of 30%, the expected number of participants is 20. With 10 
participants in the intervention group, 100 measurement points for HRV, SAM, and 
walking distance each are expected; thus, ensuring adequate power for aim 2 and 3. 
 
For the PEDI CAT and 6MWT, to achieve 80% power, the projected sample size in 
each group is estimated to be 16 and 20; therefore, we proposed that we may not be 
adequately powered for aim 1.51,68 However, findings attributed to aim 1 will provide 
pilot data to inform a larger randomized control trial. Although aim 1 may not be adequately power, the 
published minimal detectable change (MDC) for the PEDI CAT 
selfcare and mobility domains are 2.2 and 2.5 respectively while the Minimally 
Clinically Important Difference (MCID) for the 6MWT is 7%.69,70 Although, power to 
find a statistically significant difference may be inadequate, we expect to observe this 
level/magnitude of improvement in our proposed study. Variation values from this aim 
will provide data that are essential to guide future research. 
 
Data Analyses 
Aim 1: In children undergoing HCT during in-patient care, do a randomized group 
receiving a combination of Physical Therapy (PT) plus Art Therapy (AT) have improved 
functional activity level outcomes of self care and mobility as measured by the 
Pediatric Evaluation of Disability Inventory Computerized Adaptive Test and the 
6-Minute Walk Test, compared with a group receiving PT only. 
Hypothesis 1: Children receiving the combined intervention of PT plus AT will 
demonstrate greater improvements in self care and mobility skills. 
Statistical Test: Independent sample t-tests 
 
Aim 2: Do children receiving PT plus AT have physiological (sympathetic or 
parasympathetic) and emotional responses to oil pastels and gouache as measured 
by respiratory sinus arrhythmia derived from heart rate variability and Self- 
Assessment Manikin scores during each of the daily AT sessions. 
Hypothesis 2: Oil pastels or gouache AT will generate a RSA value in the direction of 
needed parasympathetic activity and balance the emotions of valence, arousal, and 
dominance. 
Statistical Test: Repeated measures generalized linear regression 
 
Aim 3: 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. 
Hypothesis 3: The media that best generates a parasympathetic RSA value and 
emotional balance will be associated with a greater walking distance. 
Statistical Test: Repeated measures generalized linear regression 
 
 
Data Collection 

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The 10-day intervention will begin on approximately Day 15 of HCT. Pre-test (Pediatric Evaluation of 
Disability Inventory and 6-Minute Walk Test) will be collected on Day 14. The same post-test data will 
be collected the day following the tenth day of intervention.  
 
During the 10 days of intervention, the Self Assessment Manikin, heart rate variability, and walking 
distance will be collected daily.  
 
The study coordinator will be responsible for storing all data. All documentation and data concerning each 
participant will be coded to protect confidentiality. All data collection and storage processes and locations 
will use study equipment (i.e., heart rate variability monitors, computers, College of Health Professions 
DA server) that is password protected, encrypted, and behind the MUSC firewall. All study related 
equipment will be locked in the office of the PI when not in use. There will be no transfer of data to a 
third party. 
 
Procedures 
1) IRB approval 
2) Begin participant enrollment 
3) Collaborate with HCT team to initiate recruitment and share study flyer 
4) PI will obtain informed consent from participants in the hospital or electronically through MUSC 
secure email.  
5) Randomize participant to AT and PT or PT only  
6) Approximately Day 14 of HCT complete pre-test (Pediatric Evaluation of Disabilities Inventory and 6-
Minute Walk Test) 
7) Day 15-24 of HCT: 45 minutes of AT and 30 minutes of PT OR 30 minutes of PT only. Heart rate 
variability, Self Assessment Manikin, accelerometry collected across sessions.  
8) Approximately Day 25 of HCT complete post-test (Pediatric Evaluation of Disabilities Inventory and 
6-Minute Walk Test) 
9) Data analyses and dissemination. 
 
11.0 Specimen Collection and Banking (if applicable) 
Not applicable. 
 
12.0 Data Management  
All documentation and data concerning each participant will be coded to protect confidentiality. All data 
collection and storage processes and locations will use study equipment (i.e., heart rate variability 
monitors, computers, College of Health Professions DA server) that is password protected, encrypted, and 
behind the MUSC firewall. All study related equipment will be locked in the office of the PI when not in 
use. There will be no transfer of data to a third party. 
 
13.0 Provisions to Monitor the Data to Ensure the Safety of Subjects (if applicable) 
All documentation and data concerning each participant will be coded to protect confidentiality. All data 
collection and storage processes and locations will use study equipment (i.e., heart rate variability 
monitors, computers, College of Health professions DA server) that is password protected, encrypted, and 
behind the MUSC firewall. All study related equipment will be locked in the office of the PI when not in 
use. There will be no transfer of data to a third party.  
  
Children undergoing HCT will experience symptoms related to the HCT and may experience additional 
medical complications. Our study involving art and physical therapy interventions will only be carried out 
during the in-patient phase, which will be helpful when considering adverse effects because a variety of 

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healthcare professionals will be at hand to possibly prevent and ameliorate any adverse events. For 
example, prior to each daily session, the art and/or physical therapist will ask the child’s nurse if the 
patient is medical stable to participate. If the nurse, reports that the child is not medically stable, then the 
child's session will be postponed until stable.  
 
Common symptoms following transplant include fatigue and deconditioning which is associated with 
lower strength and endurance.  We believe children’ participation in this study will lead to temporary 
reports of elevations in fatigue, weakness, and poorer endurance symptoms; however, we will not view 
these as adverse events since these symptoms are also common to increases in activity level that will be 
generated by art and physical therapy.  
 
Unanticipated adverse events that might be possible are falls secondary to possibly osteostatic 
hypotension or clumsiness. If an unanticipated event were to occur, the intervention therapists would 
immediately report the incident to the child’s nurse and attending physician so that appropriate assessment 
and treatment can begin. The intervention therapist would then report the event to the PI, who would 
contact the IRB and complete an adverse event report. To avoid experiencing an adverse event, before 
each intervention session, study team members will communicate with each child’s nurse concerning 
child’s medical status that day. If nursing agrees the child’s statue is stable, the intervention will proceed. 
If nursing reports that the child’s status is not stable, the intervention will be postponed. If the child 
experiences a change in medical status that requires transferred to a more complicated medical 
environment, such as the ICU, study intervention will be postponed until return to the HCT unit. If a 
child’s medical status improves and they are transferred to a “regular” hospital room, the study 
intervention will continue. Once the child is discharge to home, the study intervention will be stopped 
even if 10 days of the study intervention have not been provided.   
 
We consider this study to be low risk however our data and safety monitoring plan will be continuous, 
close monitoring by the study investigator/co-investigators of all participants. The PI (Dodds) and Co-I's 
(Hinson) will meet once a month discuss data and safety monitoring. During these meetings we will look 
for any negative trends in the data we have collected (Self Assessment Manikin, PEDI, 6-Minute Walk 
Test, heart rate variability, accelerometry) that could indicate adverse events and provide a timely 
summary report of adverse events to the IRB.  
  
Any reportable safety events that are unexpected, serious or may be related to the subjects’ participation 
in this research will be reported to the MUSC IRB and NEA in accordance with their policies.  
 
14.0 Withdrawal of Subjects (if applicable) 
Not applicable.  
 
15.0 Risks to Subjects 
As with any study there is a risk of loss in confidentiality. All documentation and data concerning each 
participant will be coded to protect confidentiality. All data collection, storage processes, and storage 
locations will use study specific equipment (i.e., heart rate variability monitors, computers, College of 
Health professions DA server) that is password protected, encrypted, and behind the MUSC firewall.  
 
Secondary to undergoing HCT, children often experience sympathetic dominance/physiological and 
emotional distress (increased heart rate, decreased HR variability, fear) and physical deconditioning 
(fatigue, atrophy, weakness, decreased endurance) in the short and long term. This study seeks to 
ameliorate these symptoms by providing AT and PT; however, during AT and PT, children may 
experience an increase in these symptoms in the short term. Since this study is being carried out during an 

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in-patient phase of treatment, the HCT care and study team will be able to easily monitor and manage any 
adverse events.  
 
Unanticipated adverse events that might be possible are falls secondary to possibly orthostatic hypotension or 
clumsiness during physical therapy and/or all walking type activities. 
 
The treatment you receive may prove to be less effective or to have more side effects than the other study 
treatment(s) or other available treatments. 
 
16.0 Potential Benefits to Subjects or Others 
Potential benefits to children in the study may include reduced and/or improved sympathetic dominance/ 
physiological and/or emotional distress and reduced and/or improved physical deconditioning in the short 
and long-term as a consequence of HCT. If daily AT and PT during the in-patient stay of improves 
outcomes, the support for daily AT and PT over the course of HCT may be improved.     
 
17.0 Sharing of Results with Subjects 
Results will be publicly disseminated through peer-review processes, which will be available to 
participating families and all interested others through the NEA website and other journals. 
 
18.0 Drugs or Devices (if applicable)  
Not applicable.  
 
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