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The Use of Therapeutic Clown in Painful Procedures in Children

NCT03122015 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-04-20

No results posted yet for this study

Summary

Children in hospitals are frequently subjected to painful procedures, including those involving needles, which are a common source of pain in children. In addition, procedural pain and anxiety can lead to various consequences for the child, as well for the parent and the nurse performing the procedure. The use of physical and psychological interventions is recommended for optimal relief of procedural pain. Moreover, these interventions can be used alone or in combination with pharmacological treatment. Although several analgesics exist and are used in clinical practice, nonpharmacological interventions aimed at the psychological component of pain are not well known and are not always used by the nurses in the pediatric practice. Distracting interventions are widely studied in the literature as it is an effective psychological intervention in the relief of pain and anxiety in children during needle-related pain procedures. The distraction by the therapeutic clown is a multi-modal intervention with multi-sensory effects and appears promising in pain relief and procedural anxiety, but not much studies have been done in the context above. The therapeutic clown can adapt to the age of the child, its culture, its reality of care and can prepare the child for painful procedures. The aim of this study is to assess the feasibility, acceptability and preliminary effects of distraction by therapeutic clown on pain and anxiety of children aged two to 17 years and the level of anxiety of the parents and nurses during a painful procedure in children.

OBJECTIFS AND QUESTIONS:

1. Assess the feasibility and acceptability of distraction by therapeutic clown with children during painful procedures. a) Is the distraction intervention by the therapeutic clown feasible and acceptable during painful procedures?
2. Assess the preliminary effects of distraction by therapeutic clown on pain and anxiety of children and the anxiety of parents and nurses. a) What are the preliminary effects of the therapy clown distraction on children's pain and anxiety, and the anxiety of parents and nurse.

Conditions

  • Pain, Acute

Interventions

OTHER

Therapeutic clown distraction

The presence of the therapeutic clown, which can adapt his interventions of distraction to the state of health of the patient and the culture of the child, is a multimodal and multi sensorial distraction intervention and can have an impact on health status, procedures, family and multidisciplinary team members. The results of five studies evaluated the effects of distraction by the clown therapy demonstrate a decrease in pain and anxiety in children aged 2 to 17 years, as well as parental anxiety in painful procedures involving needles such as venipuncture.

Sponsors & Collaborators

  • St. Justine's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-30
Primary Completion
2017-06-30
Completion
2017-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03122015 on ClinicalTrials.gov