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Using Virtual Reality Simulation to Prepare Children Undergoing MRI

Using Virtual Reality Simulation to Prepare Children Undergoing MRI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04402216
Enrollment
165
Registered
2020-05-26
Start date
2020-07-15
Completion date
2024-05-01
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Distress

Keywords

anxiety, distress, virtual reality, MRI, pediatrics, child life, certified child life specialist, VR, preparation

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.

Interventions

BEHAVIORALChild Life-led preparation

Support from a certified child life specialist in preparation for MRI

BEHAVIORALMRI preparation video

A descriptive video about what to expect when undergoing MRI

BEHAVIORALKindVR 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

Sponsors

Children's Hospital Colorado
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Anxiety Ratingimmediately before MRI scanPre-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.

Secondary

MeasureTime frameDescription
Demographic Informationcollected retrospectively within 24 hours after verbal consent is obtainedage, ethnicity, gender, type of MRI will be pulled via the electronic medical record retrospectively
MRI Scan Qualityimmediately after MRI scanThe 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.
Visit Satisfactionimmediately after MRI scanThe 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.
Anxiety Ratingimmediately after MRI scanPost-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.
Modified Yale Preoperative Anxiety Scale (m-YPAS) Distress Ratingcollected while patient is MRI scanThis 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.
Technician feedbackimmediately after MRI scanA 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026