Conscious SedationPPNCT00809380
Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial
A study testing Parental presence in people with Conscious Sedation and Anxiety, run by St. Justine's Hospital at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Conscious Sedation, Anxiety
- What is being tested?
- Parental presence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Parental presence, Control
- Keywords
- Conscious sedation, Parental presence, Invasive procedure, Children, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental presenceBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at discharge (2 hours post randomisation)
The parents' anxiety will be measured using the STAI scores.
Measured: At discharge (approximately 2 hours post randomisation)
Secondary outcomes (6)
Procedure time
Measured: 1 hours
Doses and types of medications used
Measured: 1 hour
Fracture reduction success and failure rates
Measured: 1 hour
Attempt of reduction by the residents
Measured: 1 hour
STAI and STAIC scores in children at induction of conscious sedation will be compared between both groups
Measured: 1 hour
Children's anxiety levels will also be assessed with the modified Yale Preoperative Anxiety Scale
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startJun 2009
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Study ws terminated because of a too low recruitment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Association des Médecins d'Urgence du Quebec
- Responsible party
- Principal investigator, Jocelyn Gravel, St. Justine's Hospital
- Investigators
- Jocelyn Gravel, MD, Principal investigator, St. Justine's HospitalNathalie Gaucher, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809380
- Sponsor's protocol ID
- PP
- Acronym
- PP
- Status last verified
- Mar 2013
- First submitted
- 15 Dec 2008
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00809380
- Acronym / sponsor ID
- PP / PP
- Conditions
- Conscious Sedation, Anxiety
- Keywords
- Conscious sedation, Parental presence, Invasive procedure, Children, Anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study ws terminated because of a too low recruitment rate.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Association des Médecins d'Urgence du Quebec
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parental presence | Experimental | Behavioral: Parental presencePatients 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 | Behavioral: ControlOne 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
- Parents with moderate to severe mental retardation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parental presencePatients 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. | Behavioural | Parental presence |
| ControlOne 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. | Behavioural | Control |
Primary outcome
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)
The parents' anxiety will be measured using the STAI scores.
Time frame: At discharge (approximately 2 hours post randomisation)
6 secondary outcomes
Procedure time
Time frame: 1 hours
Doses and types of medications used
Time frame: 1 hour
Fracture reduction success and failure rates
Time frame: 1 hour
Attempt of reduction by the residents
Time frame: 1 hour
STAI and STAIC scores in children at induction of conscious sedation will be compared between both groups
Time frame: 1 hour
Children's anxiety levels will also be assessed with the modified Yale Preoperative Anxiety Scale
Time frame: 1 hour
Results and safety
The study was stopped early (reason given: Study ws terminated because of a too low recruitment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jocelyn Gravel, MD principal investigator
St. Justine's Hospital
Nathalie Gaucher, MD principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental presence in people with Conscious Sedation and Anxiety, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study ws terminated because of a too low recruitment rate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2013.