Virtual Reality Storytelling for Anxiety

(STM Trial)

Overseen By Toni Tidy, BHSc, CCRA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Must not be taking: Psychotropic medications

Disqualifiers: Chronic illnesses, Neurodevelopmental disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

118 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Who Is on the Research Team?

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?

Group I: Interactive Virtual Application Experimental Treatment 1 Intervention

Online application

Group II: Standard of Care Active Control 1 Intervention

No intervention and Hospital Standard of Care

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training patient and family storytellers and patient and family faculty. Morrise, L., Stevens, KJ.[2021]

A pilot study involving 200 final-year medical students showed that animated videos featuring clinician stories about medical errors significantly improved student engagement and understanding of patient safety.

Most students believed that these personal stories would positively influence their future medical practice, indicating the potential for storytelling as an effective educational tool in medical training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Animated stories of medical error as a means of teaching undergraduates patient safety: an evaluation study. Cooper, K., Hatfield, E., Yeomans, J.[2023]

This systematic review analyzed 13 studies on visual narrative interventions for adult anxiety, identifying three main types of visual artifacts: virtual reality, videos, and drawings, which showed positive effects on anxiety conditions.

The review suggests that future studies should use double-blinded randomized control trials and consider factors like artifact origin and user interactivity to improve the efficacy and reliability of visual narrative interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual stimuli in narrative-based interventions for adult anxiety: a systematic review. Lin-Stephens, S.[2021]

The study found that using narrative video clips in virtual reality hotel websites significantly helps reduce travel anxiety, confirming the effectiveness of this approach through experiments with human subjects.

Key aspects highlighted in the videos, such as escape routes and neighborhood information, were identified as crucial for providing psychological relief, enhancing the overall virtual reality experience for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alleviating travel anxiety through virtual reality and narrated video technology. Ahn, JC., Lee, O.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality: using the virtual world to improve quality of life in the real world. Anderson, PL., Rothbaum, BO., Hodges, L.[2019]

Virtual reality (VR) has been effectively used over the past 20 years to enhance mental health across various clinical conditions, including chronic pain, neurological disorders, and psychological issues.

Recent studies indicate that VR can help correct perceptual distortions of self and environment, which are crucial for mental well-being, by creating virtual body ownership illusions, suggesting a promising avenue for future clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Body Ownership Illusions for Mental Health: A Narrative Review. Matamala-Gomez, M., Maselli, A., Malighetti, C., et al.[2021]

A review of eight studies, including six randomized clinical trials, found that virtual reality (VR) interventions significantly improve symptoms of paranoia, including reduced anxiety and suspicious thoughts.

Despite some limitations like cost, VR-based treatments are shown to be effective and safe for enhancing social participation and alleviating paranoid symptoms in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality-based interventions for patients with paranoia: A systematic review. Monaghesh, E., Samad-Soltani, T., Farhang, S.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Narrative medicine: feasibility of a digital narrative diary application in oncology. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A call for narrative: the patient's story and anesthesia training. [2019]

3. Italy pubmed.ncbi.nlm.nih.gov

[Narrative medicine in the oncological clinical practice: the path from a story-telling intervention to a narrative digital diary.] [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Training patient and family storytellers and patient and family faculty. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Animated stories of medical error as a means of teaching undergraduates patient safety: an evaluation study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Visual stimuli in narrative-based interventions for adult anxiety: a systematic review. [2021]

7. Slovakia pubmed.ncbi.nlm.nih.gov

Alleviating travel anxiety through virtual reality and narrated video technology. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Virtual reality: using the virtual world to improve quality of life in the real world. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Body Ownership Illusions for Mental Health: A Narrative Review. [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

Virtual reality-based interventions for patients with paranoia: A systematic review. [2022]