Medical Clowns for Pediatric Blood Draw

NCT03671317 | Unknown

• 1 other identifier: APP-18-03557
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

palliative care; medical clowning; anxiety relief; pain reduction; distraction; humor; papoose; restraints

Outcome Measures

Primary Outcomes (1)

• 2-Item anxiety intensity measure

  Compare the difference in self reported scores on the Children's Anxiety and Pain Scale 0-4 prior to and 0-4 following intervention, between control and experimental groups

  30 minutes

Secondary Outcomes (1)

• 2-item pain intensity measure

  30 minutes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Medical Clowning

Non-intervention group

NO INTERVENTION

This arm will continue usual care with no intervention from medical clowns. They will be asked to complete pre and post surveys about the blood draw process.

Interventions

Medical Clowning BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Participants will be excluded if they have severe developmental disabilities or are both blind and deaf.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

LAC+USC Medical Center

Los Angeles, California, 90033, United States

Location

Related Publications (6)

• Friedler S, Glasser S, Azani L, Freedman LS, Raziel A, Strassburger D, Ron-El R, Lerner-Geva L. The effect of medical clowning on pregnancy rates after in vitro fertilization and embryo transfer. Fertil Steril. 2011 May;95(6):2127-30. doi: 10.1016/j.fertnstert.2010.12.016. Epub 2011 Jan 6.

  PMID: 21211796 BACKGROUND

• Dafna Tener, Nessia Lang-Franco, Shoshi Ofir & Rachel Lev-Wiesel (2012) The Use of Medical Clowns as a Psychological Distress Buffer During Anogenital Examination of Sexually Abused Children, Journal of Loss and Trauma, 17:1, 12-22, DOI: 10.1080/15325024.2011.578025

  BACKGROUND

• Meiri N, Ankri A, Hamad-Saied M, Konopnicki M, Pillar G. The effect of medical clowning on reducing pain, crying, and anxiety in children aged 2-10 years old undergoing venous blood drawing--a randomized controlled study. Eur J Pediatr. 2016 Mar;175(3):373-9. doi: 10.1007/s00431-015-2652-z. Epub 2015 Oct 16.

  PMID: 26475347 BACKGROUND

• Meiri N, Ankri A, Ziadan F, Nahmias I, Konopnicki M, Schnapp Z, Itzhak Sagi O, Hamad Saied M, Pillar G. Assistance of Medical Clowns Improves the Physical Examinations of Children Aged 2-6 Years. Isr Med Assoc J. 2017 Dec;19(12):786-791.

  PMID: 29235739 BACKGROUND

• Goldberg A, Stauber T, Peleg O, Hanuka P, Eshayek L, Confino-Cohen R. Medical clowns ease anxiety and pain perceived by children undergoing allergy prick skin tests. Allergy. 2014 Oct;69(10):1372-9. doi: 10.1111/all.12463. Epub 2014 Aug 4.

  PMID: 24943088 BACKGROUND

• Rimon A, Shalom S, Wolyniez I, Gruber A, Schachter-Davidov A, Glatstein M. Medical Clowns and Cortisol levels in Children Undergoing Venipuncture in the Emergency Department: A Pilot Study. Isr Med Assoc J. 2016 Nov;18(11):680-683.

  PMID: 28466619 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brent Blair

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Mellinger

CONTACT

2035367286; rmelling@usc.edu

Zachary Steel

CONTACT

zsteel@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Institute for Theatre & Social Change

Model Details: Participants are 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. Data collection involves pre then post surveys to measure anxiety and pain levels for comparison. After screening, consent, and randomization, the participants and legal guardians assigned to both arms will complete a survey. Once completed, the intervention arm is introduced to two medical clowns who accompany the participant through the blood draw process. The non intervention arm will continue with usual care. Audio recording begins when participants of both arms enter the blood draw room. Once the nurse leaves the room after venipuncture, all participants and legal guardians complete a second questionnaire. At the conclusion of the study, the medical staff are asked to answer a questionnaire rated on the Likert Scale.

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 14, 2018
• Study Start: September 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 15, 2019
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)