Clinical trial NCT04402216: Using Virtual Reality Simulation to Prepare Children Undergoing MRI
Official title: Using Virtual Reality Simulation to Prepare Children Undergoing MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Distress
Keywords: anxiety
distress
virtual reality
MRI
pediatrics
child life
certified child life specialist
VR
preparation
Lead sponsor: Children's Hospital Colorado
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 165
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety Rating
timeFrame: immediately before MRI scan
Secondary outcomes:
measure: Visit Satisfaction
timeFrame: immediately after MRI scan
measure: Demographic Information
timeFrame: collected retrospectively within 24 hours after verbal consent is obtained
measure: MRI Scan Quality
timeFrame: immediately after MRI scan
measure: Technician feedback
timeFrame: immediately after MRI scan
measure: Anxiety Rating
timeFrame: immediately after MRI scan
measure: Modified Yale Preoperative Anxiety Scale (m-YPAS) Distress Rating
timeFrame: collected while patient is MRI scan
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References: