VR Mindfulness for Pediatric Surgical Anxiety

BB
Overseen ByBrandon Benchimol-Elkaim
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: McGill University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I am scheduled for surgery at SHC-Canada.
I am between 10 and 17 years old.
Ability to use Virtual Reality (VR) equipment, including wearing VR goggles and following mindfulness program instructions
See 2 more

Exclusion Criteria

Participant being screened reports severe psychiatric conditions or use of medications that significantly alter anxiety levels (as assessed using the Youth Pediatric Symptom Checklist, self or parent-report)
I have cognitive or physical issues that make mindfulness or VR hard for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Participants complete one guided mindfulness session using a VR headset, involving breathing, sensory awareness, and grounding exercises.

1 day
1 session (virtual)

Feedback and Evaluation

Parents and clinicians provide feedback on the intervention's acceptability, appropriateness, and feasibility.

1 day
1 session (virtual)

Follow-up

Participants are monitored for immediate changes in anxiety, calmness, and state mindfulness after the intervention.

1 day

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?

1

Treatment groups

Experimental Treatment

Group I: Operation Calm InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials
421
Recruited
1,017,000+

Shriners Hospitals for Children,Canada

Collaborator

Trials
1
Recruited
1,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/42708403/

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.

(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.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40698894/

Preoperative Virtual Reality for Pediatric Patients ...

This meta-analysis evaluates the effects of preoperative virtual reality interventions on various outcomes in pediatric patients. Methods ...

Virtual 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 ...

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38742940/

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 ...