Though much attention has been given to the practice of parental presence during invasive procedures in children in the ED, few studies have examined the patient's perspective. The only study to have addressed this issue used a single visual analog scale, which is not a well validated tool to assess children's distress level. Furthermore, no studies have assessed parental presence during fracture reduction; only a few incidental cases were reported in the literature. Finally, most studies evaluating parental presence had methodological limitations because of the absence of a control group. The investigators seek to assess whether parental presence during fracture reduction under sedation, in children 8 to 18 years of age, decreases anxiety levels in both parents and children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
12
Patients in the study group will be accompanied by one of their parents for the whole procedure. Before this, a short explanation of the procedure, the patient's expected behavior during the procedure and what roles parents should play will be given to the parent by the research assistant. Parents will be seated close to the patient's head and will wear radiology proof gowns. If deemed necessary by the attending physician or if their behavior becomes unacceptable, parents can be asked to leave the procedure room at any given time. Parents will be allowed to leave the procedure room if they wish to at any time during the procedure.
One parent will stay with their child until he is in the procedure room and conscious sedation has begun. He will then be asked to leave the room and wait in an adjoining waiting room. The attending physician will invite the parent back in the room once the reduction is complete and the cast is done.
CHU Sainte-Justine
Montreal, Quebec, Canada
The children's anxiety will be measured using the State-Trait Anxiety Inventory (STAI) score (in children older than 12) or State-Trait Anxiety Inventory for children (STAIC) scores (in children from 8 to 12 years old)
Time frame: at discharge (2 hours post randomisation)
The parents' anxiety will be measured using the STAI scores.
Time frame: At discharge (approximately 2 hours post randomisation)
Procedure time
Time frame: 1 hours
Doses and types of medications used
Time frame: 1 hour
Fracture reduction success and failure rates
Time frame: 1 hour
Attempt of reduction by the residents
Time frame: 1 hour
STAI and STAIC scores in children at induction of conscious sedation will be compared between both groups
Time frame: 1 hour
Children's anxiety levels will also be assessed with the modified Yale Preoperative Anxiety Scale
Time frame: 1 hour
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