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Procedural Pain in Children: Intervention With the Hospital Clown

NCT ID: NCT03366623

Last Updated: 2017-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-18

Study Completion Date

2017-01-18

Brief Summary

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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

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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

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Pain, Acute Venous Puncture Children, Adult

Keywords

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Pain assessment Self report Hospital clown intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Hospital clown intervention

The performance of the hospital clown included creating a relation with the child by using different techniques in the venipuncture procedure.

The hospital clown used distraction techniques with music, songs, toys, fake tattoos (a small sticker/label with a picture applied to the skin with water), dream journeys, storytelling and making agreements in collaboration with the child, parents and healthcare personnel.

Group Type OTHER

Hospital clown

Intervention Type BEHAVIORAL

Presence of the hospital clown

No hospital clown intervention

The clinical staff, defined as pediatric nurses and biomedical laboratory technologists, assisted the child in the venipuncture procedure with conventional communication, comfort and care techniques.

Group Type OTHER

No hospital clown intervention

Intervention Type BEHAVIORAL

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

Interventions

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Hospital clown

Presence of the hospital clown

Intervention Type BEHAVIORAL

No hospital clown intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg University

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Helle Nygård kristensen

Ph.d. student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helle N Kristensen

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Other Identifiers

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Pediatric pain 2017

Identifier Type: -

Identifier Source: org_study_id