Skip to main content
OpenTrials
Completed

NCT Number: NCT02687243

StoryTelling Medicine Application Using a Virtual Reality Intervention

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interactive Virtual Application

Device

Online application via tablet

Primary outcomes

  1. Change in Preoperative anxiety

    Time frame: Baseline, Day 1 and One Month

  2. Change in Heart rate

    Time frame: Baseline and Day 1

  3. Change in Salivary Cortisol

    Time frame: Baseline and Day 1

    Saliva cortisol test in ng/dL

Secondary outcomes

  1. Anesthetic induction compliance

    Time frame: Day 1

  2. Anesthetic Dosage for Sedation

    Time frame: Day 1

    Anesthetic agent and dosage used

  3. Delirium

    Time frame: Day 1

    Nursing notes

  4. Length of Stay

    Time frame: Day 1

    Hospital records

  5. Analgesic Usage

    Time frame: Day 1

    Medication Chart

  6. Post-Hospital Behaviour

    Time frame: One month

    Using Post-Hospital Behaviour Questionnaire (PHBQ)

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • St. Joseph's Healthcare Hamilton

Registry information

Official study title

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

Acronym: STM

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Feb 22, 2016
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.