StoryTelling Medicine Application Using a Virtual Reality Intervention (STM)

Assessing the Effects of an Interactive Virtual Reality Intervention in Reducing Preoperative Anxiety in Children Undergoing Elective Surgery: A Randomized Controlled Trial Study Protocol

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Device: Interactive Virtual Application

Detailed Description

Children with PA not only suffer physically and emotionally, but some of them will develop fear of physicians and healthcare providers. These children tend to avoid future medical care and can lead to increased suffering for the child and their family, as well as higher rates of morbidity and health care costs.

There is a paucity of research evaluating the effects of AudioVisual interventions in reducing perioperative anxiety in children undergoing surgery. To date, no one has examined the physiological effects of PA or interventions designed to reduce it.

In the past 2 years, the investigators have conducted 3 pilot studies that have examined the stability of perioperative anxiety in children (n=90) and parents, as well as the feasibility of our recruitment and testing protocol, and to pilot test the interactive tablet-based application. The investigators have established that PA can be reliably and validly measured in children and that the rate of participant recruitment, data collection, website adherence and follow-up protocols for the proposed study are feasible and acceptable. The investigators will now progress to conduct the randomized controlled trial (RCT).

This RCT will be the first to examine the effects of STM in reducing PA and perioperative outcomes in children undergoing elective surgery. Therefore, the investigators will include both behavioral (i.e., observer- and self-rated) and biological measures of stress (i.e., heart rate, salivary cortisol) to further our understanding of the impact of STM on PA.

Unlike existing interventions, the customizable STM program provides a simulated hospital environment that can not only educate, but also increase children's coping abilities to better prepare them for surgery. In addition to reducing children's PA, it can also play an important role in reducing parental anxiety by preparing parents with a knowledge tool to support their child throughout the surgical process.The investigators believe that STM is a promising tool to improve children's health and ease the familial and societal costs of PA in an easy and cost-effective way. Given that many children in other hospitals do not receive adequate preoperative preparation, STM has the potential to provide proper perioperative care for every child in need.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children between the ages of 8-13 who are scheduled to receive any outpatient surgery (i.e. tonsillectomy, herniorrhaphy)

Exclusion Criteria:

• Children with chronic illnesses (e.g., cancer), known neurodevelopmental disorders, or who are on psychotropic medications prior to randomization will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interactive Virtual Application; Online application	Device: Interactive Virtual Application; Online application via tablet
No Intervention: Standard of Care; No intervention and Hospital Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Preoperative anxiety		Baseline, Day 1 and One Month
Change in Heart rate		Baseline and Day 1
Change in Salivary Cortisol	Saliva cortisol test in ng/dL	Baseline and Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthetic induction compliance		Day 1
Anesthetic Dosage for Sedation	Anesthetic agent and dosage used	Day 1
Delirium	Nursing notes	Day 1
Length of Stay	Hospital records	Day 1
Analgesic Usage	Medication Chart	Day 1
Post-Hospital Behaviour	Using Post-Hospital Behaviour Questionnaire (PHBQ)	One month

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: Desigen Reddy, MD, Hamilton Health Sciences Corporation

Publications and helpful links

General Publications

• Chow CH, Van Lieshout RJ, Schmidt LA, Dobson KG, Buckley N. Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery. J Pediatr Psychol. 2016 Mar;41(2):182-203. doi: 10.1093/jpepsy/jsv094. Epub 2015 Oct 17.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: January 15, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimated): February 22, 2016

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: pediatrics; anesthesia; anxiety; preoperative
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2015-1220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No