VR Mindfulness for Pediatric Surgical Anxiety
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new virtual reality (VR) mindfulness tool, called Operation Calm EEMCF-VR, designed to reduce anxiety in children and teens before surgery. Participants will use a VR headset to immerse themselves in a calming nature environment with guided breathing and relaxation exercises. The goal is to determine if this approach is practical, user-friendly, and effective in easing anxiety. Children and teens in Canada, aged 6 to 17, who speak English or French and have a smartphone compatible with the VR headset, may be suitable candidates. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance pre-surgery experiences for young patients.
What prior data suggests that this VR mindfulness intervention is safe for children and adolescents?
Research has shown that virtual reality (VR) treatments like Operation Calm are generally safe for children and teenagers. Studies have found that VR effectively reduces anxiety without causing major side effects. For example, a review noted that VR lowers anxiety more effectively than other non-drug methods, with few to no negative effects. Another study found that children using VR to prepare for surgery felt less anxious and experienced only mild VR sickness, such as dizziness or nausea. Overall, VR treatments in medical settings for kids are well-received, making them a promising option for managing anxiety.12345
Why are researchers excited about this trial?
Researchers are excited about Operation Calm EEMCF-VR because it offers a unique, immersive approach to managing surgical anxiety in children and teens. Unlike traditional methods like counseling or medication, this treatment uses a smartphone-compatible virtual reality headset to create a calming 360° nature environment combined with guided mindfulness exercises. This innovative delivery method helps children engage in paced breathing, sensory awareness, and grounding techniques, potentially making it a more appealing and interactive option for young patients. By providing an engaging and tech-forward solution, Operation Calm aims to reduce anxiety without the side effects associated with medication.
What evidence suggests that this VR mindfulness intervention is effective for reducing pediatric surgical anxiety?
Research has shown that virtual reality (VR) can help reduce anxiety in children and teens before surgery. In one study, children's anxiety levels dropped significantly after using VR, from an average score of 151.33 to 41.72. Another study found that VR also lowers anxiety in both children and their parents during surgery. In this trial, participants will use the "Operation Calm" VR intervention, which combines an immersive 360° nature environment with guided mindfulness exercises. These results suggest that the immersive experience of VR, along with mindfulness exercises, could effectively manage anxiety in young patients facing surgery.678910
Are You a Good Fit for This Trial?
This trial is for children and teens aged 10-17 who are about to have surgery and may feel anxious beforehand. Participants should be able to use virtual reality equipment and follow mindfulness instructions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants complete one guided mindfulness session using a VR headset, involving breathing, sensory awareness, and grounding exercises.
Feedback and Evaluation
Parents and clinicians provide feedback on the intervention's acceptability, appropriateness, and feasibility.
Follow-up
Participants are monitored for immediate changes in anxiety, calmness, and state mindfulness after the intervention.
What Are the Treatments Tested in This Trial?
Interventions
- Operation Calm EEMCF-VR
Trial Overview
The study compares a VR-based nature mindfulness program, where kids experience calming natural scenes with guided exercises, against standard (non-VR) mindfulness before surgery. Participants are randomly assigned to one of the two groups.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Children and adolescents aged 6-17 years will complete one guided Operation Calm session using a smartphone-compatible virtual reality headset. The session combines an immersive 360° nature environment with guided mindfulness exercises involving paced breathing, sensory awareness, grounding, and present-moment attention. Each child will view one of five nature scenes. Parents and clinicians will view the intervention through a secure online link without using a VR headset and will provide feedback on its acceptability, appropriateness, usefulness, and feasibility.
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University
Lead Sponsor
Shriners Hospitals for Children,Canada
Collaborator
Citations
The Effect of Virtual Reality Technology on Anxiety in ...
Objective: To assess the effectiveness of VR in alleviating anxiety in children and their guardians during eye surgery under general anesthesia.
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researchgate.net
researchgate.net/publication/407540808_Preoperative_virtual_reality_education_for_children_undergoing_surgery_a_randomized_controlled_trial(PDF) Preoperative virtual reality education for children ...
Children's anxiety scores showed a sharper decline in the intervention group (from M = 151.33 pre-procedure to M = 41.72 post-surgery) compared ...
Effect of Virtual Reality Intervention of Postoperative Pain in ...
The purpose of this quality improvement project will be to implement Virtual. Reality (VR) amongst preoperative pediatric surgical patients ages seven to 18 ...
Efficacy of Virtual Reality-Based Intervention...
This study aimed to evaluate the effectiveness of an immersive VR-based intervention for reducing preoperative anxiety among adult patients undergoing elective ...
Operation Calm: VR Nature-Based Mindfulness to Reduce ...
Operation Calm is a research study exploring whether virtual reality (VR) can help reduce anxiety in children and adolescents before surgery.
Preoperative Virtual Reality for Pediatric Patients ...
This meta-analysis evaluates the effects of preoperative virtual reality interventions on various outcomes in pediatric patients. Methods ...
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researchgate.net
researchgate.net/publication/390273545_Virtual_reality_on_perioperative_anxiety_in_pediatric_patients_A_narrative_reviewVirtual reality on perioperative anxiety in pediatric patients
Evidence indicates that VR is more effective in reducing anxiety compared to other nonpharmacological strategies, particularly benefiting ...
VR Lowers Anxiety in Caregivers of Surgery-Bound Children
Increased child anxiety contributes to uncooperative anesthetic inductions, prolonged recovery, increased postoperative pain and delirium, and ...
Use of Virtual Reality in the Pediatric Perioperative Setting ...
Following the surgery, patients retrospectively reported anxiety, pain, and VR sickness experienced during VR use using the FAS, FPS-R, and ...
Use of Biofeedback-Based Virtual Reality in Pediatric ...
Conclusions: Children and adolescents undergoing surgery successfully learned behavioral strategies with VR-BF with 10-minute sessions once ...
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