Clinical trial NCT03366623: Procedural Pain in Children: Intervention With the Hospital Clown
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Venous Puncture
Children, Adult
Keywords: Pain assessment
Self report
Hospital clown intervention
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2017-12-08
Enrollment: 111
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity measure on a FACES Pain Scale combined with a Numerical 0-10 Rating Scale
timeFrame: During a time interval of between 0-5 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Aalborg University Hospital
name: Helle N Kristensen
role: PRINCIPAL_INVESTIGATOR
References: