Preoperative Anxiety Experienced by the Pediatric Patient study: Operation Calm EEMCF-VR
Official title Evaluating Operation Calm With Children, Parents, and Clinicians
ClinicalTrials.gov ID: NCT07694934
What this study is testing
- What it's testing
- The study wants to find out if the VR nature‑based mindfulness session is practical, acceptable, and easy to use, and whether it changes kids’ anxiety and calmness right after the session.
- Who it's for
- Children aged 6 to 17 who feel anxious before medical or dental procedures, plus their parents and the doctors who treat them.
- What's involved
- Kids will do one guided VR mindfulness session that shows a 360° nature scene and includes breathing and sensory exercises. Parents and doctors will watch the session online and give feedback. The study will collect data on how well the program works and how people feel about it.
- Time commitment
- Participants will take part in a single VR session and complete brief surveys afterward; the whole study lasts only a few days for each child.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older. Healthy volunteers may be eligible.
You may be able to join if
- Children and Adolescents
- Aged 6-17 years
- Able to understand English or French
- Residing in Canada
- Have access to a smartphone compatible with the YouTube application and the study's smartphone-compatible VR headset
You likely can't join if
- Children and Adolescents
- Unable to safely or comfortably use the VR headset
- Unable to view the intervention or complete the questionnaires
- Unable to provide assent or consent, as applicable
- Parent or legal guardian does not provide informed consent
- Any health, sensory, developmental, or technical limitation that, in the judgment of the research team, would prevent safe participation or...
See the full eligibility criteria
- Children and Adolescents
- Aged 6-17 years
- Able to understand English or French
- Residing in Canada
- Have access to a smartphone compatible with the YouTube application and the study's smartphone-compatible VR headset
- Able to view the VR intervention and complete the study questionnaires
- Parent or legal guardian provides informed consent
- Child provides assent, or the adolescent provides consent, as applicable based on age and ethics requirements Parents or Legal Guardians
- A parent or legal guardian of a child or adolescent aged 6-17 years
- Able to understand English or French
- Able to view the Operation Calm intervention through a secure online link and complete the study questionnaires
- Provides informed consent Clinicians
- A healthcare professional with experience working with children or adolescents in medical, dental, or procedural care
- Able to understand English or French
- Able to view the Operation Calm intervention through a secure online link and complete the study questionnaires
- Provides informed consent
- Children and Adolescents
- Unable to safely or comfortably use the VR headset
- Unable to view the intervention or complete the questionnaires
- Unable to provide assent or consent, as applicable
- Parent or legal guardian does not provide informed consent
- Any health, sensory, developmental, or technical limitation that, in the judgment of the research team, would prevent safe participation or completion of the study procedures Parents and Clinicians
- Unable to understand English or French
- Unable to view the intervention or complete the study questionnaires
- Does not provide informed consent
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Canada
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, but 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, 6 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.