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ChildrenNCT07073027

How Digital Media Affects Kids' Healthcare Experiences and Outcomes

A study testing 2D video on smartphone, 360 video on smartphone and 360 video on smartphone inserted into VR cardboard headset in people with Children and Adolescent, run by British Columbia Children's Hospital at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 5 to 23 yearsHealthy volunteers can take part
Conditions the study is for
Children, Adolescent, Anxiety
What is being tested?
2D video on smartphone, 360 video on smartphone and 360 video on smartphone inserted into VR cardboard headset
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteCanada
Study dates
Jul 2025to Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 23 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • BC Children's Hospital

    Vancouver, British Columbia, V6H 3N1

    Brian Greeley, PhD, 604-875 2345 ext. 7098, brian.greeley@digitallab.org

    Recruiting

Other trials in Canada

About this study

Official title: Evaluating the Impact of Digital Media on Patient-Reported Experience and Outcomes in Pediatrics

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)?

Read the detailed description

Children experience anxiety before medical procedures, which have negative effects. Educating them about what to expect can help reduce this anxiety. In this study, the investigators aim to prepare children for procedures using 2D and 360 video with audio, including virtual reality (VR). Children and adolescents aged 5-18 and adults aged 19-23 will be randomized to receive either 2D video with audio-, 360 video with audio-, or 360 video with audio in VR-based preparation materials. Participants will complete patient-reported outcomes and experience surveys before and after their preparation through a secure mobile app, accessible through their smartphone. The investigators hypothesize that VR video-based education will reduce anxiety and improve patient experience compared to when patients learn about their procedure through a 2D video with audio and a 360 video with audio without VR. The investigators further hypothesize that the media fidelity, in terms of level of immersiveness, will have an effect on associated outcomes.

In this study the investigators plan to recruit 500 participants between the ages of 5 to 23. Participants will be randomized into one of 3 preparation groups (e.g., 2D video w/ audio, 360 video w/ audio w/o VR, or 360 video w/ in VR). Participants in the 2D video-preparation group will watch and hear descriptions about the hospital environment, equipment, staff, and / or their scheduled upcoming procedure. Participants in the 360 video with audio-based preparation group will also see and hear descriptions of the hospital environment, equipment, staff, and / or their scheduled upcoming procedure. However, unlike the 2D video-based group, 360 video group will have the ability to swipe on their phone and see 360 views of the environment (i.e., the procedure room). Participants in the 360 video with audio in VR-based preparation group will see and hear videos of the hospital environment, equipment, staff, and /or their scheduled upcoming procedure in VR. Participants randomly assigned to this group will have the ability to move their head around using a cardboard VR headset and see 360 views of the hospital environment. Each participant will have their media tailored to their specific procedure. For example, participants that are undergoing a cast removal will be given different media (i.e., cast removal specific material) compared to someone who is scheduled to receive a magnetic resonance imaging scan. Participants will use their preparation materials at least once, approximately 1 week prior to their scheduled procedure.

Participants (i.e., patients) will take a series of short surveys before and after experiencing their preparation material. Surveys will include self-report anxiety and pain measures. After the procedure, the investigators plan to follow-up with the participants at 3 separate occasions. During follow-up assessments the investigators will ask participants about their anxiety as well as pain. The patient's caregivers will also complete baseline state and trait anxiety measures in addition to a satisfaction survey, but all other surveys / measures will be completed by the patient (i.e., child).

Interested participants will first complete an online screening survey to ensure their eligibility on Qualtrics. Upon successful screening, the user will be allowed to proceed to the consent and assent agreement page on Qualtrics. After consent and assent, participants will complete baseline survey data (demographics, trait anxiety) on Qualtrics. After baseline survey data, the study team will email the user to a link to where participants will be asked to download and register (password, and e-mail address) to access the app. In this way, data collected in the app will be de-identified but linked to the consent form data that is collected on Qualtrics via a randomly generated number that will be recorded by the app. All intervention media (2D video with audio, 360 video with audio w/o VR, and 360 video with audio in VR) will be accessed through the secure app (in compliance with local and provincial/national data collection/residency policies). This app will need to be downloaded. Upon successful registration, the research team will provide them with a unique code. The code will allow participants to enter into the app and the appropriate room where their material is located. Because Qualtrics is embedded within the app, participants will complete surveys within the app but through Qualtrics.

To access the media (2D video with audio, 360 video with audio on smartphone, or 360 video with audio viewed in VR) participants will explore a gamified version of the BC Children's Hospital. Participants will create an avatar and set a procedure date before leaving the home room (i.e., a bedroom). After setting a procedure date, participants will be able to access the lobby of the hospital and their procedure room (provided that it is within 7 days of their scheduled procedure). The gamified hospital environment is modeled after BC Children's Hospital and included non-playable characters, a learning kiosk, and a computer to finish surveys.

For those randomized to receive the 360 video-based preparation, participants will receive standard-of-care specific to the division/clinic that scheduled their procedure, with audio-based descriptions of their upcoming procedure, as well as videos. Videos will contain a voice-over tour and procedural experience, specific to the participant's procedure, including an orientation to the hospital environment, equipment, and sometimes each procedural step specific to their procedure. Thus, there will be multiple 360 video-based exposure and education videos, each one specific to the procedure the participant is scheduled to have. Participants randomized to the 360 video with audio WITHOUT VR, will watch the videos on their phone without the use of a VR headset. They will be able to swipe on their phone and move the video around to fully experience the hospital environment. Participants randomized to the immersive arm of the study (e.g., VR), will be able to view video in virtual reality with the use of a VR-viewer / headset that utilizes their existing mobile phone. The VR headset will be provided to participants at the time of recruitment or sent to them through mail.

Participants in the 2D video with audio-based group will receive standard-of-care specific to the division/clinic that scheduled their procedure plus 2D video with audio-based preparation. 2D video with audio-based preparation will include and spoken descriptions of the hospital environment, the staff, equipment, and / or each procedural step specific to their procedure. Therefore, persons that are in the 2D video with audio-based preparation group will receive the same information as the 360 video groups, however, all exposure / education will be in a 2D video format (image stills played in a video) that is specific to the procedure the participant is scheduled to have. Therefore, there will be multiple 2D video with audio-based exposure scenarios, each one specific to the procedure the participant is scheduled to have.

All participants will use a standalone mobile app to access their preparation media. It should be noted that all participants will have the opportunity to access a VR tutorial as a part of their participation in this study. Participants that are not randomized to the immersive video arm will not be able to access content specific to their procedure, but instead will be able to experience a VR environment briefly within the gamified version of the hospital. All participants will be able to do this.

Being tested
2D video on smartphone, 360 video on smartphone, 360 video on smartphone inserted into VR cardboard headset
Keywords
pre-procedural anxiety, exposure therapy, virtual reality, education, children and adolescents, gamification
Medical subject headings
Anxiety Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2D video on smartphoneOther

    2D video with audio viewed on smartphone

  • 360 video on smartphoneOther

    360 video with audio viewed on smartphone (not in virtual reality)

  • 360 video on smartphone inserted into VR cardboard headsetOther

    360 video with audio in virtual reality

Study groups in NCT07073027
Study groupRoleWhat they receive
2D video on phoneActive comparatorIn the 2D video arm, participants will see still images of the procedural room and tools / medical equipment that are played in a video. Each video contains a series of still images of the procedure room and stills of tools / medical equipment used in the procedure room (e.g., cast saw for the cast removal procedure, a coil for the MRI scan, etc.). As the narrator describes each tool / medical equipment an enlarged image of that tool medical equipment appears along with text. The participants randomized into this arm will hear the same audio as the other 2 arms (360 video, 360 video in VR). The difference in this group is that participants cannot interact with their media (i.e., they cannot swipe their smart phone or move their phone to look around the procedural room unlike the 360 video groups).
Receives: Other: 2D video on smartphone
360 video on phone without virtual realityActive comparatorIn the 360 video arm, participants will see a still image of the procedural room played in a video format. Each video contains a single still 360 image of the procedure room and the tools / medical equipment used in the procedure room (e.g., cast saw for the cast removal procedure, a coil for the MRI scan, etc.). As the narrator describes each tool / medical equipment an enlarged image of that tool medical equipment appears at the side of the tool / medical equipment along with text (similar to the 2D video). The participants randomized into this arm will hear the same audio as the other 2 arms (2D video, 360 video in VR). The difference in this group is that participants can interact with their media (i.e., they can swipe their smart phone using their finger to see an entire 360 view of the procedural room, but unlike the 360 VR group, this 360 group will not be using it the VR headset).
Receives: Other: 360 video on smartphone inserted into VR cardboard headset
360 video on phone in virtual realityExperimentalIn the 360 video in virtual reality arm, participants will see a still image of the procedural room played in a video format. Each video contains a single still 360 image of the procedure room and the tools / medical equipment used in the procedure room (e.g., cast saw for the cast removal procedure, a coil for the MRI scan, etc.). As the narrator describes each tool / medical equipment an enlarged image of that tool medical equipment appears at the side of the tool / medical equipment along with text (similar to the 2D video). The participants randomized into this arm will hear the same audio as the other 2 arms (2D video, 360 video in VR). The difference in this group is that participants can interact with their media using a VR headset (i.e., they can move their head, or physically turn around which moves the point of view of the video and thus their view of the procedural room).
Receives: Other: 360 video on smartphone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 1 day after procedure

  4. 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.

    Measured: 1 week after procedure

  5. 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.

    Measured: 4 weeks after procedure

Secondary outcomes (5)
  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.

    Measured: 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.

    Measured: Periprocedural

  3. 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.

    Measured: 1 day after procedure

  4. 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.

    Measured: 1 week after procedure

  5. 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.

    Measured: 4 weeks after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2025
  2. Study startJul 2025 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07073027
Sponsor's protocol ID
H24-00446
Status last verified
Jul 2025
First submitted
24 Jun 2025
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing 2D video on smartphone, 360 video on smartphone and 360 video on smartphone inserted into VR cardboard headset in people with Children and Adolescent, run by British Columbia Children's Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brian Greeley, PhD (604-875 2345 ext. 7098, brian.greeley@digitallab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety (time frame: Baseline (immediately before the intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.

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