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Medical Clowns for Pediatric Blood Draw

NCT03671317 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-07-31

No results posted yet for this study

Summary

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.

Conditions

  • Anxiety State
  • Pain
  • Stress

Interventions

BEHAVIORAL

Medical Clowning

This arm will receive a medical clowning intervention in addition to pre and post surveys about the blood draw process.

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Brent Blair · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2019-12-01
Completion
2019-12-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03671317 on ClinicalTrials.gov