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

Anxiety Clinical Trial

— PP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00809380
• Other study ID #: PP
• Status: Terminated
• Phase: N/A
• First received: December 15, 2008
• Last updated: March 18, 2013
• Start date: June 2009
• Est. completion date: October 2011

Study information

• Verified date: March 2013
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Quebec: Ministere de la santeCanada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Conscious Sedation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
St. Justine's Hospital	Association des Médecins d'Urgence du Quebec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	The parents' anxiety will be measured using the STAI scores.		At discharge (approximately 2 hours post randomisation)	No
Secondary	Procedure time		1 hours	No
Secondary	Doses and types of medications used		1 hour	No
Secondary	Fracture reduction success and failure rates		1 hour	No
Secondary	Attempt of reduction by the residents		1 hour	No
Secondary	STAI and STAIC scores in children at induction of conscious sedation will be compared between both groups		1 hour	No
Secondary	Children's anxiety levels will also be assessed with the modified Yale Preoperative Anxiety Scale		1 hour	No