Clinical Trials Directory

Trials / Completed

CompletedNCT03366623

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
111 (actual)
Sponsor
Aalborg University Hospital · Academic / Other
Sex
All
Age
4 Years – 15 Years
Healthy volunteers
Accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHospital clownPresence of the hospital clown
BEHAVIORALNo hospital clown interventionPresence of pediatric nurses and biomedical laboratory technologists in the venipuncture procedure.

Timeline

Start date
2016-04-18
Primary completion
2017-01-18
Completion
2017-01-18
First posted
2017-12-08
Last updated
2017-12-08

Source: ClinicalTrials.gov record NCT03366623. Inclusion in this directory is not an endorsement.