Virtual reality program to reduce anxiety in children before surgery
Assessing the Effects of an Interactive Virtual Reality Intervention in Reducing Preoperative Anxiety in Children Undergoing Elective Surgery: A Randomized Controlled Trial Study Protocol
This study tests a new virtual reality program to see if it can help reduce anxiety in children aged 8-13 before they have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 8 Years to 13 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT02687243 on ClinicalTrials.gov |
What this trial studies
This clinical trial tests a novel interactive tablet-based Virtual Reality program called StoryTelling Medicine (STM) designed to reduce preoperative anxiety in children aged 8-13 undergoing elective surgeries. The program prepares children by guiding them through hospital settings in an age-appropriate and customizable manner. The study will measure both behavioral and biological indicators of stress, such as heart rate and salivary cortisol, to assess the effectiveness of the intervention. This randomized controlled trial builds on previous pilot studies that established the feasibility of the approach.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 8-13 scheduled for outpatient surgeries like tonsillectomy or herniorrhaphy.
Not a fit: Patients with chronic illnesses, known neurodevelopmental disorders, or those on psychotropic medications prior to randomization may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce preoperative anxiety in children, leading to better surgical outcomes and recovery experiences.
How similar studies have performed: While there is limited research on the use of audiovisual interventions for reducing perioperative anxiety in children, this approach is innovative and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamilton, Ontario
- McMaster Children's Hospital — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Desigen Reddy, MD — Hamilton Health Sciences Corporation
- Study coordinator: Toni Tidy, BHSc, CCRA
- Email: anesresearch@mcmaster.ca
- Phone: 905-525-9140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.