StoryTelling Medicine Application Using a Virtual Reality Intervention (STM)
Primary Purpose
Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Interactive Virtual Application
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring pediatrics, anxiety, anesthesia, preoperative
Eligibility Criteria
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
Sites / Locations
- McMaster Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interactive Virtual Application
Standard of Care
Arm Description
Online application
No intervention and Hospital Standard of Care
Outcomes
Primary Outcome Measures
Change in Preoperative anxiety
Change in Heart rate
Change in Salivary Cortisol
Saliva cortisol test in ng/dL
Secondary Outcome Measures
Anesthetic induction compliance
Anesthetic Dosage for Sedation
Anesthetic agent and dosage used
Delirium
Nursing notes
Length of Stay
Hospital records
Analgesic Usage
Medication Chart
Post-Hospital Behaviour
Using Post-Hospital Behaviour Questionnaire (PHBQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02687243
Brief Title
StoryTelling Medicine Application Using a Virtual Reality Intervention
Acronym
STM
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
pediatrics, anxiety, anesthesia, preoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interactive Virtual Application
Arm Type
Experimental
Arm Description
Online application
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
No intervention and Hospital Standard of Care
Intervention Type
Device
Intervention Name(s)
Interactive Virtual Application
Intervention Description
Online application via tablet
Primary Outcome Measure Information:
Title
Change in Preoperative anxiety
Time Frame
Baseline, Day 1 and One Month
Title
Change in Heart rate
Time Frame
Baseline and Day 1
Title
Change in Salivary Cortisol
Description
Saliva cortisol test in ng/dL
Time Frame
Baseline and Day 1
Secondary Outcome Measure Information:
Title
Anesthetic induction compliance
Time Frame
Day 1
Title
Anesthetic Dosage for Sedation
Description
Anesthetic agent and dosage used
Time Frame
Day 1
Title
Delirium
Description
Nursing notes
Time Frame
Day 1
Title
Length of Stay
Description
Hospital records
Time Frame
Day 1
Title
Analgesic Usage
Description
Medication Chart
Time Frame
Day 1
Title
Post-Hospital Behaviour
Description
Using Post-Hospital Behaviour Questionnaire (PHBQ)
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toni Tidy, BHSc, CCRA
Phone
905-525-9140
Ext
21737
Email
anesresearch@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desigen Reddy, MD
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26476281
Citation
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.
Results Reference
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StoryTelling Medicine Application Using a Virtual Reality Intervention
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