AnxietySTMNCT02687243
StoryTelling Medicine Application Using a Virtual Reality Intervention
A study testing Interactive Virtual Application in people with Anxiety, run by McMaster University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Interactive Virtual Application
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 8-13 who are scheduled to receive any outpatient surgery (i.e. tonsillectomy, herniorrhaphy)
Who cannot join
- Children with chronic illnesses (e.g., cancer), known neurodevelopmental disorders, or who are on psychotropic medications prior to randomization will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Interactive Virtual Application
- Keywords
- pediatrics, anxiety, anesthesia, preoperative
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Virtual ApplicationDevice
Online application via tablet
| Study group | Role | What they receive |
|---|---|---|
| Interactive Virtual Application | Experimental | Online application Receives: Device: Interactive Virtual Application |
| Standard of Care | No intervention | No intervention and Hospital Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Preoperative anxiety
Measured: Baseline, Day 1 and One Month
Change in Heart rate
Measured: Baseline and Day 1
Change in Salivary Cortisol
Saliva cortisol test in ng/dL
Measured: Baseline and Day 1
Secondary outcomes (6)
Anesthetic induction compliance
Measured: Day 1
Anesthetic Dosage for Sedation
Anesthetic agent and dosage used
Measured: Day 1
Delirium
Nursing notes
Measured: Day 1
Length of Stay
Hospital records
Measured: Day 1
Analgesic Usage
Medication Chart
Measured: Day 1
Post-Hospital Behaviour
Using Post-Hospital Behaviour Questionnaire (PHBQ)
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study start20 Nov 2019
- Primary completion1 May 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Desigen Reddy, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687243
- Sponsor's protocol ID
- 2015-1220
- Acronym
- STM
- Status last verified
- Jun 2026
- First submitted
- 15 Jan 2016
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26476281
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02687243
- Acronym / sponsor ID
- STM / 2015-1220
- Conditions
- Anxiety
- Keywords
- pediatrics, anxiety, anesthesia, preoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Virtual Application | Experimental | Device: Interactive Virtual ApplicationOnline application |
| Standard of Care | No intervention | –No intervention and Hospital Standard of Care |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the ages of 8-13 who are scheduled to receive any outpatient surgery (i.e. tonsillectomy, herniorrhaphy)
Key exclusion criteria (1 listed)
- Children with chronic illnesses (e.g., cancer), known neurodevelopmental disorders, or who are on psychotropic medications prior to randomization will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Virtual ApplicationOnline application via tablet | Device | Interactive Virtual Application |
Primary outcome
Change in Preoperative anxiety
Time frame: Baseline, Day 1 and One Month
Change in Heart rate
Time frame: Baseline and Day 1
Change in Salivary Cortisol
Time frame: Baseline and Day 1
Saliva cortisol test in ng/dL
6 secondary outcomes
Anesthetic induction compliance
Time frame: Day 1
Anesthetic Dosage for Sedation
Time frame: Day 1
Delirium
Time frame: Day 1
Length of Stay
Time frame: Day 1
Analgesic Usage
Time frame: Day 1
Post-Hospital Behaviour
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 26476281Chow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Desigen Reddy, MD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Virtual Application in people with Anxiety, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Preoperative anxiety (time frame: Baseline, Day 1 and One Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02687243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.