Anxiety, Procedural Anxiety
Conditions
Keywords
Pain
Brief summary
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.
Interventions
BEHAVIORALStandard of Care
Participant is allowed to use what they will use as a distraction tool while they are receiving treatment.
BEHAVIORALImmersive technology
Participants will be randomly assigned to one of the following four groups; VR headsets, a bluetooth haptic device (Buddy Guard), a screen and projector (BERT), and a tablets with a game. Participant's anxiety will be assessed and pre- and post-intervention assessments will be completed.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patient age between 4-17 * English speaking * Parental consent/patient assent * Undergoing minor procedure(s) at LPCH or Stanford Hospital
Exclusion criteria
* Patient does not consent * Legal guardian not present to obtain consent * Patient with a significant neurological condition or major developmental disability * Patient experiencing nausea * Patient with active infection of the face or hand * A history of severe motion sickness * A history of visual problems * A history of seizures caused by flashing light * Major surgery within the last 48 hours * Patients who are clinically unstable or require urgent/emergent intervention * Patient or parental preference for general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of technological interventions on anxiety levels in patients who undergo minor procedures | baseline, immediately after the intervention | Participants will complete the Visual Analogue Scale for Anxiety (VAS-A), a self-report scale to measure anxiety levels before and after the technological intervention. The scale is a horizontal line from 0 to 10 with an anchor at 0 indicating "no anxiety" and an anchor at 10 indicating "worst possible anxiety". |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of technological interventions on pain levels in patients whose age is 4-11 years old and undergo minor procedures | baseline, immediately after the intervention | The FSP-R is a self-report measure of pain intensity displaying six faces representing equal intervals between the scale values from least pain = 0 to most pain = 10 |
| To evaluate pain levels pre- and post-intervention, participants will complete the Numerical Rating Pain Scale (NRPS) for patients 12-17 years old. | baseline, immediately after the intervention | The NRPS quantifies pain intensity on a scale from 0, being no pain, to 10, being the worst imaginable pain. |
| To evaluate patient's, clinician's, and caregiver's satisfaction levels | immediately after the intervention | To analyze the patient's, clinician's, and caregiver's satisfaction levels, the feedback in the satisfaction survey at the end will be evaluated. The purpose of this analysis is to provide qualitative data on which aspects of the technological intervention the patient received mattered the most to the patient, clinician, and caregiver. |
| To evaluate the patient's affect during the intervention using HRAD | during minor procedure | HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation. |
| To evaluate the patient's cooperation during the intervention using the modified Induction Compliance Checklist (mICC) | during minor procedure | The mICC score will be recorded by the trained research observers during the minor procedure.11 behaviors that are commonly observed preoperatively will be recorded. Perfect compliance (score of 0) was compared to those that lacked cooperation. mICC will be rated at the time of intervention and only requires one RA. |
Countries
United States
Outcome results
None listed