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

NCT00809380 | Terminated

• 1 other identifier: PP
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Conscious Sedation; Anxiety

Keywords

Conscious sedation; Parental presence; Invasive procedure; Children; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (2)

Parental presence

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Parental presence BEHAVIORAL

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.

Parental presence

Control BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Parents able to understand basic spoken English or French.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Association des Médecins d'Urgence du Quebec: collaborator

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jocelyn Gravel, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Nathalie Gaucher, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 17, 2008
• Study Start: June 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

CA (1)