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)

Trial Summary

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 data supports the effectiveness of the treatment StoryTelling Medicine Application (STM) for anxiety?

Research shows that storytelling in medicine can improve understanding and empathy between patients and healthcare providers, which may help reduce anxiety. Additionally, storytelling has been used to enhance patient satisfaction and safety, suggesting it could be beneficial in managing anxiety.12345

How is the StoryTelling Medicine Application treatment different from other anxiety treatments?

The StoryTelling Medicine Application is unique because it uses virtual reality (VR) storytelling to engage users in a narrative experience, which can help externalize and rescript anxiety. Unlike traditional treatments, this approach leverages immersive VR technology to create an interactive and participatory environment, potentially enhancing the therapeutic effects for anxiety relief.678910

What is the purpose of this trial?

Preoperative anxiety (PA) affects up to 5 million children in North America each year and is associated with adverse medical, psychological, and behavioral effects. Children who are highly anxious often require more medications during surgical procedures and take longer to recover. While many attempts have been made to reduce PA in children, existing interventions are limited by their expense and time intensive nature. Thus, the current lack of effective and efficient methods of reducing anxiety in children before and after surgery has prompted us to develop and propose to test a new intervention. The investigators have developed a novel,interactive tablet based Virtual Reality program, StoryTelling Medicine (STM), to help reduce anxiety in children undergoing elective surgery, and its associated negative effects.STM is an age appropriate, customizable program to prepare children for complex surgical procedures by guiding them through the hospital settings. The investigators will examine if STM is effective in reducing PA and its adverse effects in children undergoing surgery. If effective, STM has the potential to improve children's and families' surgical experiences, and reduce health problems in the hospital setting and beyond.

Research Team

DR

Desigen Reddy, MD

Principal Investigator

Hamilton Health Sciences Corporation

Eligibility Criteria

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

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Interactive Virtual ApplicationExperimental Treatment1 Intervention
Online application
Group II: Standard of CareActive Control1 Intervention
No intervention and Hospital Standard of Care

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

Findings from Research

In a preliminary study involving 31 oncology patients, the Digital Narrative Medicine (DNM) platform was found to be feasible and beneficial, with 67% of patients actively using the diary to document their treatment experiences.
Health care professionals reported that the DNM improved communication and strengthened their relationships with patients, with high utility scores indicating its potential value in clinical practice.
Narrative medicine: feasibility of a digital narrative diary application in oncology.Cercato, MC., Colella, E., Fabi, A., et al.[2022]
Narratives in medical education, particularly from patients and trainees, provide valuable insights into the human aspects of healthcare, enhancing understanding for medical professionals, including anesthesiologists.
Patients often find therapeutic benefits in sharing their stories, expressing hopes that their experiences will improve future patient care and interactions with healthcare providers.
A call for narrative: the patient's story and anesthesia training.Shafer, A., Fish, MP.[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]

References

Narrative medicine: feasibility of a digital narrative diary application in oncology. [2022]
A call for narrative: the patient's story and anesthesia training. [2019]
[Narrative medicine in the oncological clinical practice: the path from a story-telling intervention to a narrative digital diary.] [2019]
Training patient and family storytellers and patient and family faculty. [2021]
Animated stories of medical error as a means of teaching undergraduates patient safety: an evaluation study. [2023]
Visual stimuli in narrative-based interventions for adult anxiety: a systematic review. [2021]
Alleviating travel anxiety through virtual reality and narrated video technology. [2019]
Virtual reality: using the virtual world to improve quality of life in the real world. [2019]
Virtual Body Ownership Illusions for Mental Health: A Narrative Review. [2021]
Virtual reality-based interventions for patients with paranoia: A systematic review. [2022]
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