Anxiety Clinical Trial
Official title:
Using Virtual Reality Simulation to Prepare Children Undergoing MRI
NCT number | NCT04402216 |
Other study ID # | 20-0098 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 15, 2020 |
Est. completion date | June 2024 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Colorado |
United States,
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 |
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