118 Participants Needed

Virtual Reality Storytelling for Anxiety

(STM Trial)

TT
Overseen ByToni Tidy, BHSc, CCRA
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 tests a new virtual reality program called StoryTelling Medicine (STM) to reduce anxiety in children before surgery. STM is an interactive tablet application that guides children through hospital settings to prepare them for their procedure. The study compares this method to the usual care to determine if it can make the surgical experience less stressful and improve recovery. Children aged 8-13, scheduled for outpatient surgery like a tonsillectomy, might be suitable participants unless they have chronic illnesses or specific conditions.

As an unphased trial, this study provides a unique opportunity for children to experience innovative anxiety-reduction techniques before surgery.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications, but children on psychotropic medications (drugs affecting mood, perception, or behavior) are excluded from participating.

What prior data suggests that this Virtual Reality program is safe for children?

Research has shown that virtual reality (VR) therapy can help reduce anxiety in patients, including children. One study found that storytelling in hospitals lowers anxiety and fear in kids. This is important because anxiety can lead to increased medication needs and can slow recovery after surgery.

A review of research found that self-guided VR, such as the StoryTelling Medicine app, effectively manages anxiety. It is also considered safe because it doesn't involve medication or medical procedures. The use of VR in healthcare is growing, and many studies support its potential benefits.

Overall, VR and storytelling are easy to handle and have a low risk of side effects, making them a promising option for reducing anxiety in children before surgery.12345

Why are researchers excited about this trial?

Researchers are excited about the Virtual Reality Storytelling treatment for anxiety because it offers a unique, immersive experience that could transform anxiety management. Unlike traditional approaches like medication or talk therapy, this method uses an interactive virtual application to engage users in storytelling, providing a personalized and dynamic way to manage anxiety symptoms. This innovative approach could make treatment more accessible and engaging, especially for those who might find traditional methods less effective or appealing. The potential to offer a non-pharmacological option that leverages technology to deliver mental health support is what makes this treatment stand out.

What evidence suggests that the StoryTelling Medicine application is effective for reducing preoperative anxiety in children?

Research shows that virtual reality (VR) therapy can help reduce anxiety. Studies have found that VR serves as an effective distraction, aiding in the management of both pain and anxiety. Specifically, storytelling has reduced anxiety and fear in children during hospital stays. Additionally, digital mental health tools, such as VR programs, have shown some success in lowering anxiety symptoms. This trial will evaluate the StoryTelling Medicine Application, an interactive virtual application, to determine its effectiveness in easing anxiety in children before surgery.12678

Who Is on the Research Team?

DR

Desigen Reddy, MD

Principal Investigator

Hamilton Health Sciences Corporation

Are You a Good Fit for This Trial?

This trial is for children aged 8-13 who are scheduled for outpatient surgery like tonsillectomy or herniorrhaphy. It's not suitable for kids with chronic illnesses, neurodevelopmental disorders, or those on psychotropic medications before the study starts.

Inclusion Criteria

My child, aged 8-13, is scheduled for a minor outpatient surgery.

Exclusion Criteria

My child has a long-term illness like cancer.
My child has a diagnosed neurodevelopmental disorder.
I am not taking any psychotropic medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Children use the StoryTelling Medicine (STM) virtual reality program to reduce preoperative anxiety

1 day
1 visit (in-person)

Surgery and Immediate Postoperative Care

Children undergo elective surgery and immediate postoperative care is provided

1 day
1 visit (in-person)

Follow-up

Participants are monitored for postoperative behavior and recovery outcomes

1 month
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • StoryTelling Medicine Application
Trial Overview The trial tests a new interactive tablet-based Virtual Reality program called StoryTelling Medicine (STM), designed to reduce preoperative anxiety in children by familiarizing them with hospital settings before surgery.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Interactive Virtual ApplicationExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

Published Research Related to This Trial

Virtual reality (VR) is being increasingly utilized by mental health professionals to enhance treatment outcomes for various conditions, including specific phobias, posttraumatic stress disorder, eating disorders, and pain management.
Research indicates that VR has immersive properties that can significantly improve clinical interventions, making it a promising tool in modern mental health care.
Virtual reality: using the virtual world to improve quality of life in the real world.Anderson, PL., Rothbaum, BO., Hodges, L.[2019]
The narrative path program at the IRCSS 'Regina Elena' National Cancer Institute, initiated in 2015, emphasizes the importance of storytelling in clinical practice to enhance understanding and communication between patients and healthcare providers.
A pilot study in 2017 demonstrated that integrating patient narratives with clinical data during chemotherapy is feasible and beneficial, but its success relies heavily on the involvement of the entire care team and effective health organization.
[Narrative medicine in the oncological clinical practice: the path from a story-telling intervention to a narrative digital diary.]Cercato, MC.[2019]
Narrative medicine enhances empathy between clinicians and patients by fostering a deeper understanding of the patient experience, which can lead to improved healthcare quality and safety.
Training patients and families in effective storytelling can empower them to share their experiences, making their narratives more impactful and contributing to a patient- and family-centered care culture.
Training patient and family storytellers and patient and family faculty.Morrise, L., Stevens, KJ.[2021]

Citations

Effectiveness of virtual reality therapy in the treatment ...The current findings suggest that VR therapy interventions have a positive effect on improving the anxiety state of patients with anxiety disorders.
Effect of storytelling on anxiety and fear in children during ...Compared to standard care, storytelling was found to be effective in reducing anxiety and/or fear in children during hospitalization. Anxiety scores were not ...
A Review of Current Digital Mental Health Care ...The results of RCTs on the efficacy of the applications gen- erally demonstrate small to moderate effect sizes in reducing symptoms of anxiety.
Effects of Virtual Reality Application on Pain, Anxiety, and ...Virtual reality (VR) applications stand out as an effective method for managing pain and anxiety by providing distraction. However, existing studies generally ...
Effectiveness and User Experience of Virtual Reality for Social ...The findings showed that VR exposure therapy–based interventions can generally provide effective, safe, usable, and acceptable treatments for adults with SAD.
Storytelling Games for General Anxiety:Clinician ...A growing body of evidence indicates the therapeutic viability of serious games for mental health [8], and their advantages over traditional treatments because ...
Virtual reality applications in mental health: Challenges ...Virtual reality (VR) as a major tool for investigation, assessment, and management of medical and psychiatric disorders.
Review article Self-guided virtual reality therapy for anxietyThe findings revealed that self-guided VR interventions for anxiety can provide an effective treatment of social anxiety disorder, public speaking anxiety, and ...
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