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

This study has been terminated.
(Study ws terminated because of a too low recruitment rate.)
Sponsor:
Collaborator:
Association des Médecins d'Urgence du Quebec
Information provided by (Responsible Party):
Jocelyn Gravel, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT00809380
First received: December 15, 2008
Last updated: March 18, 2013
Last verified: March 2013

December 15, 2008
March 18, 2013
June 2009
October 2011   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: No ]
  • The parents' anxiety will be measured using the STAI scores. [ Time Frame: At discharge (approximately 2 hours post randomisation) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00809380 on ClinicalTrials.gov Archive Site
  • Procedure time [ Time Frame: 1 hours ] [ Designated as safety issue: No ]
  • Doses and types of medications used [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Fracture reduction success and failure rates [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Attempt of reduction by the residents [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • STAI and STAIC scores in children at induction of conscious sedation will be compared between both groups [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Children's anxiety levels will also be assessed with the modified Yale Preoperative Anxiety Scale [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial
Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Conscious Sedation
  • Anxiety
  • 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.
  • 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.
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
October 2011
October 2011   (final data collection date for primary outcome measure)

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.

Exclusion criteria for parents:

  • Parents presenting unacceptable behaviors for family presence

    • Uncooperative
    • Physically aggressive, combative
    • Threatening and argumentative
    • Unstable emotionally or cannot be calmed
    • Intoxicated or altered mental status
    • Suspicion of child abuse
    • Suspected perpetrator of violent crime
  • Parents with moderate to severe mental retardation.
  • Pregnant parent
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00809380
PP
No
Jocelyn Gravel, St. Justine's Hospital
St. Justine's Hospital
Association des Médecins d'Urgence du Quebec
Principal Investigator: Jocelyn Gravel, MD St. Justine's Hospital
Principal Investigator: Nathalie Gaucher, MD St. Justine's Hospital
St. Justine's Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP