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

Primary Purpose

Conscious Sedation, Anxiety

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Parental presence
Control
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Conscious Sedation focused on measuring Conscious sedation, Parental presence, Invasive procedure, Children, Anxiety

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

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

Sites / Locations

  • CHU Sainte-Justine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Parental presence

Control

Arm Description

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.

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.

Outcomes

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)
The parents' anxiety will be measured using the STAI scores.

Secondary Outcome Measures

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

Full Information

First Posted
December 15, 2008
Last Updated
March 18, 2013
Sponsor
St. Justine's Hospital
Collaborators
Association des Médecins d'Urgence du Quebec
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1. Study Identification

Unique Protocol Identification Number
NCT00809380
Brief Title
Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial
Acronym
PP
Official Title
Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Study ws terminated because of a too low recruitment rate.
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
Collaborators
Association des Médecins d'Urgence du Quebec

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conscious Sedation, Anxiety
Keywords
Conscious sedation, Parental presence, Invasive procedure, Children, Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parental presence
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Parental presence
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Title
The parents' anxiety will be measured using the STAI scores.
Time Frame
At discharge (approximately 2 hours post randomisation)
Secondary Outcome Measure Information:
Title
Procedure time
Time Frame
1 hours
Title
Doses and types of medications used
Time Frame
1 hour
Title
Fracture reduction success and failure rates
Time Frame
1 hour
Title
Attempt of reduction by the residents
Time Frame
1 hour
Title
STAI and STAIC scores in children at induction of conscious sedation will be compared between both groups
Time Frame
1 hour
Title
Children's anxiety levels will also be assessed with the modified Yale Preoperative Anxiety Scale
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyn Gravel, MD
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nathalie Gaucher, MD
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada

12. IPD Sharing Statement

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

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