Technology-Based Distractions for Minor Procedures
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patient age between 4-17
English speaking
Parental consent/patient assent
Undergoing minor procedure(s) at LPCH or Stanford Hospital
Disqualifiers
Patient does not consent
Legal guardian not present to obtain consent
Patient with a significant neurological condition or major developmental disability
Patient experiencing nausea
Trial design
Design model
Parallel
Treatments tested in this trial
Standard of Care
BehavioralParticipant is allowed to use what they will use as a distraction tool while they are receiving treatment.
Immersive technology
BehavioralParticipants 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Standard of Care groupActive comparator 1 intervention
Group B: Immersive Technology grorupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the effectiveness of technological interventions on anxiety levels in patients who undergo minor procedures
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".
Time frame
baseline, immediately after the interventionSecondary outcomes
1
Evaluate the effectiveness of technological interventions on pain levels in patients whose age is 4-11 years old and undergo minor procedures
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
Time frame
baseline, immediately after the intervention2
To evaluate pain levels pre- and post-intervention, participants will complete the Numerical Rating Pain Scale (NRPS) for patients 12-17 years old.
The NRPS quantifies pain intensity on a scale from 0, being no pain, to 10, being the worst imaginable pain.
Time frame
baseline, immediately after the intervention3
To evaluate patient's, clinician's, and caregiver's satisfaction levels
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.
Time frame
immediately after the intervention4
To evaluate the patient's affect during the intervention using HRAD
HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation.
Time frame
during minor procedureSponsors and contacts
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Source ClinicalTrials.gov
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