Pain, Acute Clinical Trial
Official title:
The Use of Therapeutic Clown in Painful Procedures in Children: A Pilot Study
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.
1. BACKGROUND
1.1 Hospitalized children under 18 years old are frequently undergo painful procedures
including needles. Although children often have interventions to relieve pain during
the period of hospitalization, few interventions are implemented specifically for
painful procedures. Studies show that pain and anxiety associated with the painful
procedure, such as needles, can lead to various physiological, physical and
psychological consequences in children, as avoidance of medical care. In addition,
physiological and psychological effects such as increased heart rate, blood pressure,
and anxiety levels were also noted with parents who accompanied their child during a
painful procedure. These effects on parents increase the anxiety of the child, which
amplifies the pain felt by the child.
Moreover, the effects of procedural pain do not only affect the child and his parents.
Studies reveal that these painful procedures result in impotence and an increased level
of anxiety among professionals performing the procedures, which in turn have an impact
on children's anxiety and pain. Finally, procedural pain can lead to a lack of
collaboration between the child, increasing the length of the procedure and the need
for staff.
1.2 A Canadian study found that pharmacological interventions are widely used among
hospitalized children who are experiencing painful procedures but very few
non-pharmacological interventions are were used. However, since pain is a multi-sensory
experience and emotional and cognitive components modulate nociceptive treatment, the
use of analgesics alone cannot alleviate each of the components of pain. Therefore, 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.
1.3 Among non-pharmacological interventions, distraction interventions are widely
studied and recommended for pain and anxiety management experienced in children and
adolescents during needle-related pain procedures. Therapeutic clown distraction is a
form of distraction, as it has multi-sensory effects that appear promising in
children's procedural pain and anxiety management but have been little studied in this
context.
1.4 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.
2. AIM 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 7 to
17 years, and the anxiety of parents and nurses during a painful procedure in children.
OBJECTIFS AND QUESTIONS:
1. Assess the feasibility and acceptability of distraction by therapeutic 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 the pain and
anxiety of children and the anxiety of parents and nurses.
1. What are the preliminary effects of the therapy clown distraction on children's
pain and anxiety, and the anxiety of parents and nurses?
HYPOTHESES
1. Therapeutic clown distraction is a feasible and acceptable method for procedural
pain relief of children.
3. METHODS
4.1 Design.
Experimental before and after pilot study.
4.2 Sample and Setting.
This pilot study will include a group that will receive the intervention of
distraction by the therapeutic clown (CT) and the other that will receive the
standard treatment. The study will take place at St. Justine's Hospital, precisely
at the infectious diseases clinic. Recruitment of participants will be by
convenience from parents and children who will be eligible for study. The sample
of this pilot project will contain approximately 24 children in addition to
parents and the nurse who will perform the painful procedure.
4.3. Measures. Measures of anxiety will be recorded at T1, T2 and general anxiety
will be asses by parents after the procedure at T3. Measures for procedural pain
will be taken at: T2, during the procedure. Acceptability will be assessed with
parents and nurses using an satisfaction survey at T3, after the procedure.
4.4 Data analysis plan. The characteristics of children, parents and nurses will
be described using descriptive statistics. Inferential nonparametric statistics
will be used to compare the data of each group and to evaluate the preliminary
effects of interventions on child pain and anxiety and parental and nurse anxiety.
FEASIBILITY
Acceptability will be assessed with parents and nurses using an satisfaction
survey. The questionnaire 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. In the case where the child must receive several
vaccines, only the first immunization will be timed.
4. POSSIBLE PITFALLS AND SOLUTIONS
Since this study represents a pilot study, the results cannot be generalized and
will not allow us to determine whether one intervention will be more effective
than the other.
5. CONTRIBUTION AND EXPECTED RESULTS
These interventions, which we believe are feasible, could help reduce the negative
impact of painful procedures on children, parents and nurses.
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