How Digital Media Affects Kids' Healthcare Experiences and Outcomes

NCT07073027 | Recruiting

• 1 other identifier: H24-00446
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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)?

Conditions

Children; Adolescent; Anxiety; Pain; Education; Exposure; Virtual Reality

Keywords

pre-procedural anxiety; exposure therapy; virtual reality; education; children and adolescents; gamification

Outcome Measures

Primary Outcomes (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.

  Baseline (immediately before the intervention)

• 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.

  Periprocedural (immediately after the intervention)

• 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.

  1 day after procedure

• 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.

  1 week after procedure

• 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.

  4 weeks after procedure

Secondary Outcomes (5)

• Pain intensity

  Baseline (immediately before the intervention)

• Pain intensity

  Periprocedural

• Pain intensity

  1 day after procedure

• Pain intensity

  1 week after procedure

• Pain intensity

  4 weeks after the procedure

Other Outcomes (2)

• Ready for procedure and recommendation

  Periprocedural (immediately after the intervention)

• Procedure satisfaction and recommendation follow-up

  1 day after procedure

Study Arms (3)

2D video on phone

ACTIVE COMPARATOR

In 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).

Other: 2D video on smartphone

360 video on phone without virtual reality

ACTIVE COMPARATOR

In 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).

Other: 360 video on smartphone inserted into VR cardboard headset

360 video on phone in virtual reality

EXPERIMENTAL

In 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).

Other: 360 video on smartphone

Interventions

2D video on smartphone OTHER

2D video with audio viewed on smartphone

2D video on phone

360 video on smartphone OTHER

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

360 video on phone in virtual reality

360 video on smartphone inserted into VR cardboard headset OTHER

360 video with audio in virtual reality

360 video on phone without virtual reality

Eligibility Criteria

• Age: 5 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Children's Hospital: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Brian Greeley, PhD

CONTACT

604-875 2345; brian.greeley@digitallab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 18, 2025
• Study Start: July 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

CA (1)