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

• ClinicalTrials.gov Identifier: NCT00809380
• Recruitment Status: Terminated
• First Posted: December 17, 2008
• Last Update Posted: March 19, 2013
• Sponsor: St. Justine's Hospital
• Collaborator: Association des Médecins d'Urgence du Quebec
• Information provided by (Responsible Party): Jocelyn Gravel, St. Justine's Hospital

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: June 2009
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: October 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.

Outcome Measures

Primary Outcome Measures :

1. 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) ]
2. The parents' anxiety will be measured using the STAI scores. [ Time Frame: At discharge (approximately 2 hours post randomisation) ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada, Quebec

CHU Sainte-Justine

Montreal, Quebec, Canada, H3T 1C5

Sponsors and Collaborators

St. Justine's Hospital

Association des Médecins d'Urgence du Quebec

Investigators

• Principal Investigator: Jocelyn Gravel, MD; St. Justine's Hospital
• Principal Investigator: Nathalie Gaucher, MD; St. Justine's Hospital

More Information

• Responsible Party: Jocelyn Gravel, MD, MSc, St. Justine's Hospital
• ClinicalTrials.gov Identifier: NCT00809380 History of Changes
• Other Study ID Numbers: PP
• First Posted: December 17, 2008
• Last Update Posted: March 19, 2013
• Last Verified: March 2013

Keywords provided by Jocelyn Gravel, St. Justine's Hospital:

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

Additional relevant MeSH terms:

Emergencies; Disease Attributes; Pathologic Processes