Anxiety Clinical Trial
— PPOfficial title:
Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Canada | CHU Sainte-Justine | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
St. Justine's Hospital | Association des Médecins d'Urgence du Quebec |
Canada,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04579354 -
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia
|
N/A | |
Completed |
NCT03535805 -
Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Active, not recruiting |
NCT05302167 -
Molehill Mountain Feasibility Study.
|
N/A | |
Completed |
NCT05881681 -
A Mindfulness Approach to UA for Afro-descendants
|
N/A | |
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Active, not recruiting |
NCT04961112 -
Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits
|
N/A | |
Terminated |
NCT04612491 -
Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
|
||
Completed |
NCT05980845 -
The Effect Nature Sounds and Music on Hemodialysis Patients
|
N/A | |
Recruiting |
NCT05449002 -
Digital Single Session Intervention for Youth Mental Health
|
N/A | |
Completed |
NCT05585749 -
Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
|
N/A | |
Terminated |
NCT03272555 -
WILD 5 Wellness: A 30-Day Intervention
|
N/A | |
Recruiting |
NCT05997849 -
Development of a Multiplatform Mental Health Mobile Tool
|
N/A | |
Completed |
NCT06421233 -
The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels
|
N/A |