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Clinical Trials/NCT03366623
NCT03366623
Completed
N/A

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

Aalborg University Hospital0 sites111 target enrollmentApril 18, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
Aalborg University Hospital
Enrollment
111
Primary Endpoint
Pain intensity measure on a FACES Pain Scale combined with a Numerical 0-10 Rating Scale
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 18, 2016
End Date
January 18, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Helle Nygård kristensen

Ph.d. student

Aalborg University Hospital

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

Outcomes

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

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