Pain, Acute Clinical Trial
Official title:
The Use of Therapeutic Clown in Painful Procedures in Children: A Pilot Study
Verified date | April 2017 |
Source | St. Justine's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | August 31, 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Children requiring immunization. - Understand and speak French or who are accompanied by someone who understands and speaks french. - Children accompanied by at least one parent. Exclusion Criteria: - Children afraid of clowns - Children diagnosed with a mental, physical or visual impairment. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
St. Justine's Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acceptability | Acceptability will be assessed with parents and nurses using a satisfaction survey. The survey will be provided to parents in paper form and will be verbally completed by the nurse. In addition, to document the feasibility and acceptability of the study, the number of children participating, as well as the duration of the procedure and the number of professionals involved will be noted throughout the procedure. | T3 (immediately after the procedure before leaving the treatment room) | |
Secondary | Pain intensity | French version of the Face, Legs, Activity, Cry and Consolability (FLACC) | T2 (during the immunization procedure) | |
Secondary | Anxiety Level | Visual Analogue Scale (VAS). | T1 (baseline), T2 (during the procedure). |
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