PP: Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial

Sponsor

St. Justine's Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00809380

Collaborator

Association des Médecins d'Urgence du Quebec (Other)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Conscious Sedation Anxiety	Behavioral: Parental presence Behavioral: Control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Parental presence 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.	Behavioral: Parental presence 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.
Active Comparator: Control 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.	Behavioral: Control 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.

Arm

Intervention/Treatment

Experimental: Parental presence

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.

Behavioral: Parental presence

Active Comparator: Control

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.

Behavioral: Control

Outcome Measures

Primary Outcome Measures

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) [at discharge (2 hours post randomisation)]
The parents' anxiety will be measured using the STAI scores. [At discharge (approximately 2 hours post randomisation)]

Secondary Outcome Measures

Procedure time [1 hours]
Doses and types of medications used [1 hour]
Fracture reduction success and failure rates [1 hour]
Attempt of reduction by the residents [1 hour]
STAI and STAIC scores in children at induction of conscious sedation will be compared between both groups [1 hour]
Children's anxiety levels will also be assessed with the modified Yale Preoperative Anxiety Scale [1 hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria for patients:

Patients aged 8 to 18 years old.
Patients requiring fracture reduction under conscious sedation by emergency department attending physician.
Patients able to understand basic spoken English or French.

Inclusion criteria for parents:

Parents able to understand basic spoken English or French.

Exclusion criteria for patients:

Patients with moderate to severe mental retardation
Patients with altered mental status or intoxication
Patients with hemodynamic instability or several traumatic injuries (other than fractures) - these patients require several treatments and may not have time to complete our study.