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

Sponsored by:	St. Justine's Hospital
Information provided by:	St. Justine's Hospital
ClinicalTrials.gov Identifier:	NCT00809380

Purpose

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	Intervention
Conscious Sedation Anxiety	Behavioral: Parental presence Behavioral: Control

MedlinePlus related topics: Anxiety Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial

Further study details as provided by St. Justine's Hospital:

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) [ 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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	46
Study Start Date:	March 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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: 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 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.

Arms

Assigned Interventions

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

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: 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

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.

Eligibility

Ages Eligible for Study:	8 Years to 18 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809380

Contacts

Contact: Jocelyn Gravel, MD	514-345-4931	graveljocelyn@hotmail.com
Contact: Nathalie Gaucher, MD	514-345-4931	natgaucher@yahoo.com

Locations

Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5

Sponsors and Collaborators

St. Justine's Hospital

Investigators

Principal Investigator:	Jocelyn Gravel, MD	CHU Sainte-Justine
Principal Investigator:	Nathalie Gaucher, MD	CHU Sainte-Justine

More Information

No publications provided

Responsible Party:	CHU Sainte-Justine ( Jocelyn Gravel )
Study ID Numbers:	PP
Study First Received:	December 15, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00809380 History of Changes
Health Authority:	Senegal: Ministere de la sante; Canada: Health Canada; Canada: Ethics Review Committee

Keywords provided by St. Justine's Hospital:

Conscious sedation
Parental presence
Invasive procedure
Children
Anxiety

Study placed in the following topic categories:

Fractures, Bone
Emergencies

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Emergencies

ClinicalTrials.gov processed this record on May 07, 2009