NCT03671317

Medical Clowns for Pediatric Blood Draw

Status unknown NA Last updated 31 July 2019

What this trial tests

NA trial testing Medical Clowning in Anxiety State in 60 participants. Status unknown.

Timeline

1 September 2019

Primary endpoint
1 December 2019

15 December 2019

Quick facts

Lead sponsor	University of Southern California
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	1 September 2019
Primary completion	1 December 2019
Estimated completion	15 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Medical Clowning

Conditions studied

• Anxiety State — all drugs for Anxiety State →
• Pain — all drugs for Pain →
• Stress — all drugs for Stress →

Sponsor

University of Southern California

Who can join

Adults 3 to 11, any sex, with Anxiety State or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clowning in children undergoing potentially anxiety-provoking procedures: a systematic review and meta-analysis.
   Könsgen N, Polus S, Rombey T, Pieper D. · · 2019 · cited 12× · PMID 31324215 · DOI 10.1186/s13643-019-1095-4