Procedural Pain in Children: Intervention With the Hospital Clown

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.

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Key information

Conditions

Pain, Acute Acute Pain Children, Adult Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Venous Puncture

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

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.
An ethnographic study to uncover the pain experience and ability to cope during painful procedures in short-term hospitalization.
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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hospital clown

Behavioral

Presence of the hospital clown

No hospital clown intervention

Behavioral

Presence of pediatric nurses and biomedical laboratory technologists in the venipuncture procedure.

Primary outcomes

Pain intensity measure on a FACES Pain Scale combined with a Numerical 0-10 Rating Scale

Time frame: During a time interval of between 0-5 minutes

Self-reported pain measure conducted after finishing the venipuncture in the examining room

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

Aalborg University

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Dec 8, 2017
Registry last updated: Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed