Using Virtual Reality Simulation to Prepare Children Undergoing MRI

Anxiety Clinical Trial

Official title:

Using Virtual Reality Simulation to Prepare Children Undergoing MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04402216
• Other study ID #: 20-0098
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Children's Hospital Colorado
• Contact: Claire Simonsen
• Phone: 720-777-5313
• Email: Claire.Simonsen[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of using virtual reality (VR) to reduce distress in pediatric patients undergoing MRI scans compared to other methods of preparation. Children will be divided into four groups. The investigators hypothesize the children who receive Child Life preparation with VR will experience decreased distress compared to the other 3 treatment groups (no formal preparation, Child Life-led preparation, and MRI preparation video). The investigators also hypothesize that children who receive Child Life-led preparation will experience better decreased distress than current standard of care (no formal preparation) and MRI preparation video.

Description:

II. Background and Significance MRI scans can be difficult for children due to the confined space inside the MRI scanner, the loud noises that MRI scanners produce, and the amount of time that it takes to complete the scan. These factors can lead to a significant amount of distress and anxiety, both for the child undergoing the MRI scan and his or her family. Several techniques have been developed to reduce distress and anxiety in children undergoing MRI scans. Child Life Specialists have been proven to help reduce anxiety in children and better prepare them for MRI scans. Having a Child Life Specialist integrated into the multidisciplinary team treating a pediatric patient ensures that the child's emotional needs are being met as much as his or her physical needs. Evaluation and intervention from a Child Life Specialist reduce anxiety and allows for children and families to be better prepared for their MRI, reducing distress of the child undergoing MRI, and reducing the need for anesthesia. Child life specialists are also able to utilize medical play using mock scanners and coach children in breathing exercises, such as blowing bubbles or pinwheels to help children comply with holding their breath during MRI scans, resulting in clearer images. Child Life specialists play a crucial role in effective communication with families and the rest of the medical team during and after examination. III. Preliminary Studies/Progress Report Another technique that has reduced distress in children during MRI is MRI compatible video goggles, which allow children to watch videos during the MRI scan. Giving children something to focus on while inside the MRI machine helps them to stay still and feel less anxious while still remaining awake. VR is a promising technology that has been used to reduce anxiety and serve as a pain distraction during intravenous placement required for MRI and CT scans as well as with children with sickle cell disease managing vaso-occlusive pain episodes. The inherent immersive and interactive properties of VR games make them effective for pain relief and distraction and also lends VR to countless potential applications in pediatric healthcare. KindVR is an independent VR firm that develops VR software specifically for the use of pediatric patients in a hospital setting. This software has been developed to minimize significant motion, mitigating risk of motion sickness or nausea, and providing targeted, age-appropriate content. There is not yet any published evidence that VR can be used to successfully prepare children for MRI scans, but there is strong evidence that this technology, especially paired with software specifically designed for use with pediatric patients in a hospital setting can impact important outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• (1) patients aged 6- 7 years who are scheduled for an MRI scan of the brain, face, orbitals, neck, spine, lower extremity, hip, humerus, knee, tibia and fibula, ankle, shoulder, elbow, forearm, hand, and/or wrist.
• (2) without anesthesia and
• (3) without contrast

Exclusion Criteria:

• (1) cognitive impairment that negates the use of the outcome tools or use of virtual reality device;
• (2) visual impairment that could not be corrected by lenses;
• (3) non-English speaking parent or patient.

Related Conditions & MeSH terms

• Anxiety
• Distress

Intervention

Behavioral:
• Child Life-led preparation
Support from a certified child life specialist in preparation for MRI
• MRI preparation video
A descriptive video about what to expect when undergoing MRI
• KindVR Virtual Reality MRI Preparation Experience
A VR experience to prepare pediatric patients for MRI, to be used in addition to support from a certified child life specialist

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Rating	Pre-procedural anxiety level of the child will be collected via child self-report and staff report before the MRI scan. Patient and Staff will report child's anxiety using a Visual Analog Scale with anchors "Not Anxious" and "Very Anxious." VAS scores will range from 1-100, with lower scores indicating less anxiety.	immediately before MRI scan
Secondary	Visit Satisfaction	The caregiver will be given a standard Likert scale survey that rates satisfaction in the following areas: overall satisfaction with hospital visit, pain management, respect, and compassion. Guardians will be asked to select between "Very Satisfied," "Satisfied," "Neutral," and "Dissatisfied" in each of the aforementioned areas. The survey will also ask parents to rate teamwork between healthcare professionals and overall quality of care received by selecting a response of "Excellent," "Fair," "Neutral," and "Poor."	immediately after MRI scan
Secondary	Demographic Information	age, ethnicity, gender, type of MRI will be pulled via the electronic medical record retrospectively	collected retrospectively within 24 hours after verbal consent is obtained
Secondary	MRI Scan Quality	The MRI Technician will report whether the scan was complete, readable, and if rescanning was needed. Length of the MRI in minutes will be recorded as part of a procedural efficiency measure.	immediately after MRI scan
Secondary	Technician feedback	A cooperation rating will be collected from the MRI technician after the MRI scan. The technician will report the child's cooperation level using a Visual Analog Scale with anchors of "very uncooperative" and "very cooperative." VAS scores will range from 1-100, with lower scores indicating less cooperation.	immediately after MRI scan
Secondary	Anxiety Rating	Post-procedural anxiety level of the child will be collected via child self-report and staff report after the MRI scan. Patient and Staff will report child's anxiety using a Visual Analog Scale with anchors "Not Anxious" and "Very Anxious." VAS scores will range from 1-100, with lower scores indicating less anxiety.	immediately after MRI scan
Secondary	Modified Yale Preoperative Anxiety Scale (m-YPAS) Distress Rating	This structured, observational measure of preoperative anxiety in children consists of 27 items in five domains of behavior (Activity, Emotional Expressivity, State of arousal, Vocalization, and Use of parents). Using Kappa statistics, all m-YPAS domains have good to excellent inter- and intraobserver reliability; when compared with other global behavioral measures of anxiety, the m-YPAS had good validity.	collected while patient is MRI scan