How Digital Media Affects Kids' Healthcare Experiences and Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-23
SponsorBritish Columbia Children's Hospital
About this trial
The goal of this clinical trial is to learn whether different forms of media (2D, 360, or 360 in virtual reality) have different impacts on pre-procedural anxiety and post-procedural pain in children. The main questions it aims to answer are:
Does one type (and richness) of media reduce pre-procedural anxiety and post-procedural pain more than another type of media? For example, will learning about an upcoming procedure by watching a 360 video in virtual reality reduce pre-procedural anxiety more than learning about the same upcoming procedure by watching it in a 2D video or 360 video?
The second question is whether watching a 360 video in VR about an upcoming procedure more effective in reducing pre-procedural anxiety and post-procedural pain compared to the 2D video or the 360 video without VR groups for specific procedures? For example, is watching an explanation of a procedure in VR always more effective in reducing pre-procedural anxiety and post-procedural pain, or is it procedure specific (i.e., watching a video about surgery preparation is more effective in VR, but for cast removal it doesn't matter whether participants learn about their procedure viewed through VR, 360 video, or 2D)?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Between the ages of 5 to 23
Able to follow instructions and communicate in English
Own or have access to a smartphone
Scheduled for an upcoming (approved) procedure.
Disqualifiers
Under the age of 5 or older than 23
Vision, hearing, cognitive, and/or motor impairments
Cannot follow instructions and/or communicate in English
Do not own or have access to a smartphone.
Trial design
Design model
Parallel
Treatments tested in this trial
2D video on smartphone
Other intervention2D video with audio viewed on smartphone
360 video on smartphone
Other intervention360 video with audio viewed on smartphone (not in virtual reality)
360 video on smartphone inserted into VR cardboard headset
Other intervention360 video with audio in virtual reality
Treatment groups
500 Participants
are divided into 3 treatment groupsGroup A: 2D video on phoneActive comparator 1 intervention
Group B: 360 video on phone without virtual realityActive comparator 1 intervention
Group C: 360 video on phone in virtual realityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Anxiety
Measurement of anxiety. To measure state anxiety we are using the number 0-10 anxiety score. The scale goes from 0 to 10 with 10 being the worst imaginable anxiety.
Time frame
Baseline (immediately before the intervention)2
Anxiety
Measurement of anxiety. To measure state anxiety we are using the number 0-10 anxiety score. The scale goes from 0 to 10 with 10 being the worst imaginable anxiety.
Time frame
Periprocedural (immediately after the intervention)3
Anxiety
Measurement of anxiety. To measure state anxiety we are using the number 0-10 anxiety score. The scale goes from 0 to 10 with 10 being the worst imaginable anxiety.
Time frame
1 day after procedure4
Anxiety
Measurement of anxiety. To measure state anxiety we are using the number 0-10 anxiety score. The scale goes from 0 to 10 with 10 being the worst imaginable anxiety.
Time frame
1 week after procedureSecondary outcomes
1
Pain intensity
Measurement of pain using numeric rating scale of pain. The scale goes from 0 to 10 with 10 being the worst hurt you could possibly imagine.
Time frame
Baseline (immediately before the intervention)2
Pain intensity
Measurement of pain using numeric rating scale of pain. The scale goes from 0 to 10 with 10 being the worst hurt you could possibly imagine.
Time frame
Periprocedural3
Pain intensity
Measurement of pain using numeric rating scale of pain. The scale goes from 0 to 10 with 10 being the worst hurt you could possibly imagine.
Time frame
1 day after procedure4
Pain intensity
Measurement of pain using numeric rating scale of pain. The scale goes from 0 to 10 with 10 being the worst hurt you could possibly imagine.
Time frame
1 week after procedureOther outcomes
1
Ready for procedure and recommendation
In the post-intervention survey, we ask both the patients and caregivers whether they think they and their child is ready for the upcoming procedure, respectively. We ask the patient "Do you feel ready for your \[procedure\]?" with the option of "No", "Maybe", and "Yes". We also ask the patient "Pretend a family member or friend is going to have surgery like you. How likely are you to tell your family or friends about this app?" on a 0 to 10 scale with 0 labeled as "Not at all likely" and a 10 labeled as "Extremely likely". We also ask the parent / guardian, "To what extent do you think your child is ready for their procedure?" with the option of "Not at all prepared", "Somewhat prepared", "Fully prepared". We also ask the parent / guardian "How likely are you to recommend the app to other families or friends with children undergoing the same procedure?" on a 0 to 10 scale with 0 labeled as "Not at all likely" and 10 labeled as "Extremely likely".
Time frame
Periprocedural (immediately after the intervention)2
Procedure satisfaction and recommendation follow-up
We ask both the patients and parent about the procedure. We ask the patient "How did the procedure go?" with the option of "Very good", "Good", "Bad" and "Very bad". We also ask the patient and the parent "Were your prepared for your procedure?" with the option of "Yes", "No", and "I don't know". We also ask "Pretend a family member or friend is going to have surgery like you. How likely are you to tell your family or friends about this app?" on a 0 to 10 scale with 0 labeled as "Not at all likely" and a 10 labeled as "Extremely likely". We also ask the parent, "Overall, how satisfied are you with how the procedure went?" with the option of "Very dissatisfied", "dissatisfied", "Neutral ", "Satisfied", "Very Satisfied" and "N/A". We also ask the parent "How likely are you to recommend the app to other families or friends with children undergoing the same procedure?" on a 0 to 10 scale with 0 labeled as "Not at all likely" and 10 labeled as "Extremely likely".
Time frame
1 day after procedureSponsors and contacts
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Source ClinicalTrials.gov