Medical Clowns for Pediatric Blood Draw

Status:Not yet recruiting
Conditions:Anxiety, Chronic Pain
Therapuetic Areas:Musculoskeletal, Psychiatry / Psychology
Age Range:3 - 11
Start Date:June 15, 2019
End Date:December 15, 2019
Contact:Rebecca Mellinger

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Effect of Medical Clown Intervention on Anxiety and Perceived Pain Levels in Pediatric Patients Undergoing Venous Blood Draw

The research objective of this proposed clinical trial is to determine the efficacy of a
medical clowning intervention for pediatric patients undergoing venipuncture. Efficacy is
defined in terms of decreasing anxiety, pain, and crying duration, and increasing the pace
and ease of the procedure. The study population includes pediatric patients between the ages
of 3 - 11 years who must undergo venipuncture at the LAC + USC Outpatient Clinic. The
subjects will be randomized into two groups. The control subjects will receive no
intervention during blood draw, while the intervention subjects will receive the medical
clown intervention during blood draw. The clowns will interact with one patient at a time,
engaging in play with the patient and caretakers during all parts of the procedure. Duration
of crying and the duration of the entire procedure, the patient's level of pain and anxiety,
the caretaker's level of anxiety, need for restraining devices (papoose) and the efficiency
of the procedure will be measured. In order to perform the survey and self-assessment
procedures, we will implement the use of measurement scales including a novel "emoji" child
distress assessment scale, and a published adult anxiety scale (State-Trait Anxiety Inventory
Form Y-1). The data will be analyzed using descriptive statistics.

The scientific aim of this project is to determine the effect a medical clowning intervention
may have on perceived pain levels and anxiety levels with patients, their families, and the
medical staff during routine blood draw procedures in the Pediatric Oncology Hematology
Clinic of LAC + USC.

We are investigating the following claims: First, the physical, play-based, non-verbal based
forms of communication that a clown implements is effective in creating playful distraction
during the procedure. The presence of the clown in this capacity can meaningfully reduce
perceived pain levels in patients during venipuncture and reduce the duration of crying.
Second, the clown intervention decreases anxiety levels in the trial participants and
families leading up to and during blood draw which supports the patient as well as increases
efficiency for hospital staff. Third, the presence of the clown will significantly reduce
physical restraint (i.e. medical stabilization board, known as a papoose board) usage during
venipuncture. Lastly, we aim to prove that coulrophobia does not play a factor in medical
clowning interventions.

The USC School of Dramatic Arts Medical Clowning Program is the first academic and research
program of its kind in the country, offering a groundbreaking opportunity to develop a new
model for patient healing and wellness. While research studies have proven its effectiveness
internationally, USC hopes to become a leading player by applying, proving, and advocating
for the transformational impact of clowning in healthcare. Medical Clowns, Zachary Steel and
Caitlyn Conlin, have both been clowning at LAC + USC County Hospital for the past two years.
The practice, as perceived by the clown practitioners, staff and family members, has been
extremely effective in lowering anxiety, reframing the hospitalization experience, and as a
distraction tool. We are hoping to elevate the practice as a vital paramedical profession by
proving the efficacy of the practice in this specific setting.

Internationally, the practice of medical clowning has becoming increasingly prevalent in
hospital and community settings. The efficacy of the practice continues to be proven, all
without undue risk to human subjects, when applied to a large spectrum of populations and
settings. At Carmel Medical Center in Haifa, Israel, a study on the effect of medical
clowning on reducing pain, crying, and anxiety in children aged 2 to 10 years old undergoing
venous blood drawing proved the clowns were effective, safe, and had less negative effect on
future blood draw examinations compared with control or use of topical anesthetic.
Furthermore, integration of medical clowns in physical examination was shown to improve the
overall experience of the child and the caregivers and help the pediatrician to perform a
complete physical examination, with shorter duration of discomfort (0.2 +/- 0.6 minutes vs
1.6 +/- 2.0 minutes, p = 0.001); in the medical clown group, 94% of pediatricians reported
that the medical clown improved their ability to perform a complete physical examination.
Clowning has also successfully been used as a psychological distress buffer during anogenital
examinations of sexually abused children.

While the international community has successfully studied the efficacy of the practice, the
practice of medical clowning varies from country to country as the patient's response to
different forms of humor and play varies. Culturally, clowns play a different role in the
United States than they do elsewhere due to coulrophobia (fear of clowns) that has surfaced
in the U.S. due to blockbuster movies. In 2017, an Israeli group published a study that
showed that only 1.2% of hospitalized children were afraid of clowns. In contrast, according
to a poll conducted by Morning Consult 42% of Americans said they were, in some capacity,
afraid of clowns.

Participants will be randomized to either receive medical clowning intervention or no
intervention. The total length of subject participation is the participant's one visit to the
blood draw clinic.

Each participant randomized to the medical clowning arm will undergo one medical clowning
session which consists of two medical clowns accompanying them before, during, and after
venipuncture. The data collection procedures (surveys, recordings), are not experimental but
will be performed exclusively for research purposes. Initial pre-intervention surveys will be
administered in the waiting room to the participant and legal guardians before the blood draw
procedure. Post-intervention surveys will be administered once the participant leaves the
blood draw room. For both the intervention and non-intervention group, the nurses will
communicate to the research assistant if the papoose was used. For both the intervention and
non-intervention group, audio will begin recording the moment the participant steps into the
blood draw room to later assess duration of crying. The detailed design of the study is as

SCREENING & CONSENT FORM PHASE (15-20 minutes): Participants will be screened for eligibility
based on the inclusion and exclusion criteria. After identifying eligible candidates,
immediately following patient check-in at the clinic's front desk, the participant patient
and legal guardian will receive a written overview of the study and will have time to ask
questions regarding the purpose of the study and what's to be expected of them. If they agree
to participate, participants aged 7-11 will be asked to give assent and all legal guardians
will be asked to sign an Informed Consent Form. The participant and guardian will be given
trial specific information. All referring physicians and nurses will be informed of their
participants' enrollment. In the case that the participant and legal guardian are more
proficient in Spanish than English, all of these forms and documents will be provided to them
in Spanish.

PRE-INTERVENTION PHASE (WAITING ROOM) (15-20 minutes): All documents will be copied and
distributed / filed, including copies to the family. The participant will be registered and
randomized as per protocol. Initial pre-intervention surveys will be administered.

CLOWN INTRODUCTION PHASE (3-5 minutes): Participants and caregivers sit in a hallway before
they are admitted into a blood draw room. For the intervention patient, once the survey is
completed, the clowns will introduce themselves to the subjects and form an introductory
bond. The clown will accompany the child to the blood draw room. For the non-intervention
participant, no clown will be introduced and they will wait for the nurse to lead them into
the blood draw room to continue usual care.

CLINICAL PHASE (variable duration, estimated 30-40 minutes, depending on routine medical care
duration): For the intervention group, the nurse administers usual standard nursing care
(vitals: blood pressure cuff, temperature reading, oxygen saturation, etc.). The clowns will
work in complement, finding opportunities to connect and find play opportunities with the
patient and caretakers to ease anxiety, lessen crying duration, and improve the overall
experience. The clown engages with the participant and all caregivers in the room and
attempts to divert their focus away from pain and reduce their anxiety levels through play,
laughter, and imagination during venipuncture and other nursing care. Following the
collection of blood samples by the nurses, the clowns will stay in the room to soothe and
play a transitional role prior to returning to routine care with subsequent providers (e.g.
doctor, social worker, dietician). For the non-intervention group, no clown will be present
and the nurses will proceed with routine tests and blood draw. The nurse will use the papoose
only if determined necessary to subdue the child during venipuncture. For both the
intervention and non-intervention-groups, the nurses will communicate to the research
assistant if the papoose was used. For both the intervention and non-intervention groups,
audio will begin recording the moment a child steps into the blood draw room to later assess
duration of crying.

POST-SURVEY PHASE (10-15 minutes): Post-intervention surveys will be administered.

MEDICAL STAFF FOLLOW UP PHASE: At the end of the entire study, the medical staff will be
asked to answer a questionnaire.

Inclusion Criteria:

- Children whose treatment includes blood tests in the outpatient blood draw facility at
LAC + USC Medical Center.

Exclusion Criteria:

- Participants will be excluded if they have severe developmental disabilities or are
both blind and deaf.
We found this trial at
Los Angeles, California 90033
Phone: 323-660-2450
Los Angeles, CA
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