Procedural Pain in Children: Intervention With the Hospital Clown

Pain, Acute Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366623
• Other study ID #: Pediatric pain 2017
• Status: Completed
• Phase: N/A
• First received: November 30, 2017
• Last updated: December 7, 2017
• Start date: April 18, 2016
• Est. completion date: January 18, 2017

Study information

• Verified date: December 2017
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: January 18, 2017
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Children, Adult
• Pain, Acute
• Venous Puncture

Intervention

Behavioral:
• Hospital clown
Presence of the hospital clown
• No hospital clown intervention
Presence of pediatric nurses and biomedical laboratory technologists in the venipuncture procedure.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg Universitetshospital	Aalborg University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity measure on a FACES Pain Scale combined with a Numerical 0-10 Rating Scale	Self-reported pain measure conducted after finishing the venipuncture in the examining room	During a time interval of between 0-5 minutes