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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03366623
Enrollment
111
Registered
2017-12-08
Start date
2016-04-18
Completion date
2017-01-18
Last updated
2017-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Adult, Pain, Acute, Venous Puncture

Keywords

Pain assessment, Self report, Hospital clown intervention

Brief 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.

Interventions

BEHAVIORALHospital clown

Presence of the hospital clown

BEHAVIORALNo hospital clown intervention

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

Sponsors

Aalborg University
CollaboratorOTHER
Aalborg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity measure on a FACES Pain Scale combined with a Numerical 0-10 Rating ScaleDuring a time interval of between 0-5 minutesSelf-reported pain measure conducted after finishing the venipuncture in the examining room

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026