StoryTelling Medicine Application Using a Virtual Reality Intervention

NCT02687243 | Recruiting

• 1 other identifier: 2015-1220
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

pediatrics; anxiety; anesthesia; preoperative

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Anesthetic induction compliance

  Day 1

• Anesthetic Dosage for Sedation

  Day 1

• Delirium

  Day 1

• Length of Stay

  Day 1

• Analgesic Usage

  Day 1

Study Arms (2)

Interactive Virtual Application

EXPERIMENTAL

Online application

Device: Interactive Virtual Application

Standard of Care

NO INTERVENTION

No intervention and Hospital Standard of Care

Interventions

Interactive Virtual Application DEVICE

Online application via tablet

Interactive Virtual Application

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 26476281 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Desigen Reddy, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Toni Tidy, BHSc, CCRA

CONTACT

905-525-9140; anesresearch@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: February 22, 2016
• Study Start: November 20, 2019
• Primary Completion: May 1, 2025
• Study Completion: December 31, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)