Procedural Pain in Children: Intervention With the Hospital Clown

Hospitalized Children's Pain Experience. Effect and Influence of Intervention With the Hospital Clown in Acute and Repeated Painful Procedures. A Mixed Method Study.

This study evaluates the effect of an intervention with a hospital clown compared to standard care on pain experience for acute hospitalized children receiving venipuncture. Half of the children will receive an intervention with the hospital clown while the other half will receive standard care.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Venous Puncture; Children, Adult
• Intervention / Treatment: Behavioral: Hospital clown; Behavioral: No hospital clown intervention

Detailed Description

Background: Hospitalized children describe the pain associated with painful procedures as one of the worst experiences during hospitalization. These experiences can be traumatic for children and their families. Most children are acutely hospitalized with no chance to prepare the child for painful procedures, while others experience repeated hospitalizations. Previous negative pain experiences are known to have major consequences for future admissions and procedures. Therefore, there is a need for different interventions for pain relief. In 2004, hospital clowns became a part of the team on pediatric wards in Denmark. International studies have shown positive effects of hospital clowns on preoperative anxiety in children, but there is limited knowledge of the impact on the child's experience related to painful procedures.

The overall purpose of this study is to investigate the effect and impact of the hospital clown as a non-pharmacological intervention on hospitalized children's pain experience and ability to cope during painful procedures in both short and long-term treatment and care.

Methods: A two-faced mixed methods study design with merging and connecting results and findings.

1. A prospective, randomized open-label trial to identify whether exposure to the hospital clown has an effect on pain experience in acute hospitalized children receiving venipuncture.
2. An ethnographic study to uncover the pain experience and ability to cope during painful procedures in short-term hospitalization.
3. An ethnographic study to uncover the influence related to repeated painful procedures, as well as uncover if a relationship may have a potential long-term impact.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Acutely admitted to the hospital
• Scheduled for the venipuncture procedure
• Not prepared for the procedure before coming to the hospital
• Accompanied by at least one parent

Exclusion Criteria:

• Subjects with developmental disorders who could not cooperate with self- reporting of pain
• Subjects who were unable to speak Danish or English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hospital clown intervention; The performance of the hospital clown included creating a relation with the child by using different techniques in the venipuncture procedure. The hospital clown used distraction techniques with music, songs, toys, fake tattoos (a small sticker/label with a picture applied to the skin with water), dream journeys, storytelling and making agreements in collaboration with the child, parents and healthcare personnel.	Behavioral: Hospital clown; Presence of the hospital clown
Other: No hospital clown intervention; The clinical staff, defined as pediatric nurses and biomedical laboratory technologists, assisted the child in the venipuncture procedure with conventional communication, comfort and care techniques.	Behavioral: No hospital clown intervention; Presence of pediatric nurses and biomedical laboratory technologists in the venipuncture procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity measure on a FACES Pain Scale combined with a Numerical 0-10 Rating Scale	Self-reported pain measure conducted after finishing the venipuncture in the examining room	During a time interval of between 0-5 minutes

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Aalborg University
• Investigators: Principal Investigator: Helle N Kristensen, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2016
• Primary Completion (Actual): January 18, 2017
• Study Completion (Actual): January 18, 2017

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Pain assessment; Self report; Hospital clown intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: Pediatric pain 2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No