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New treatment option for Forearm Fractures
Official title Virtual Reality-Assisted Cast Application in Children With Forearm Fractures
ClinicalTrials.gov ID: NCT07683715
What this study is testing
- What it's testing
- This prospective randomized controlled trial will evaluate whether virtual reality can reduce procedural distress in children undergoing cast application for forearm fractures. Children will be assigned to either a virtual reality group or a standard care group.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 15
You may be able to join if
- Children aged 4 to 15 years.
- Diagnosis of an isolated forearm fracture requiring cast application with traction (greenstick injuries plastic deformation if NOT over 20 degrees...
- First cast application for the current fracture episode.
- Typically developing children without a known developmental delay or cognitive impairment that would prevent participation in the study assessments.
- Ability of the child to understand age-appropriate instructions and respond to pain, anxiety, and fear-related assessments with caregiver assistance...
You likely can't join if
- Open forearm fracture.
- Multiple trauma or an additional painful injury that may affect pain, anxiety, or fear assessment.
- Need for emergency surgery, procedural sedation, or general anesthesia during cast application.
- Previous participation in this study.
- Known developmental delay, cognitive impairment, autism spectrum disorder with inability to complete study assessments, or severe psychiatric...
- Known epilepsy, photosensitive seizure disorder, severe motion sickness, vestibular disorder, or any condition considered unsafe for VR headset use.
See the full eligibility criteria
- Children aged 4 to 15 years.
- Diagnosis of an isolated forearm fracture requiring cast application with traction (greenstick injuries plastic deformation if NOT over 20 degrees bayonet apposition ok if \<10 years and growth remains)
- First cast application for the current fracture episode.
- Typically developing children without a known developmental delay or cognitive impairment that would prevent participation in the study assessments.
- Ability of the child to understand age-appropriate instructions and respond to pain, anxiety, and fear-related assessments with caregiver assistance when necessary.
- At least one upper extremity free of immobilization, allowing heart rate assessment during the procedure.
- Parent or legal guardian able to provide written informed consent.
- Child assent when appropriate according to age and local ethics committee requirements.
- Ability and willingness of the child and caregiver to attend an approximately 30-minute blinded child psychiatry assessment 1 day after cast application.
- Open forearm fracture.
- Multiple trauma or an additional painful injury that may affect pain, anxiety, or fear assessment.
- Need for emergency surgery, procedural sedation, or general anesthesia during cast application.
- Previous participation in this study.
- Known developmental delay, cognitive impairment, autism spectrum disorder with inability to complete study assessments, or severe psychiatric disorder that may interfere with questionnaire-based evaluation.
- Known epilepsy, photosensitive seizure disorder, severe motion sickness, vestibular disorder, or any condition considered unsafe for VR headset use.
- Visual or hearing impairment preventing use of the VR intervention or completion of the assessments.
- Head, face, or scalp injury preventing safe or comfortable use of a VR headset.
- Nausea, dizziness, or severe discomfort before the procedure that would prevent VR use.
- Refusal of the child or caregiver to participate.
- Inability to complete the 1-day child psychiatry follow-up assessment.
The study team makes the final eligibility decision.
Where it's taking place
- Istanbul, Istanbul, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 15 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Istanbul, Istanbul, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.