PR-VR At-home Program During and After COVID-19

NCT ID: NCT04912817

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-12-06

Brief Summary

Poorly controlled chronic pain in teens can impact quality of life, increase opioid use and is a risk factor for developing chronic pain in adulthood. Currently, there is a shortage of support to help teens manage chronic pain in the community and the support that did exist has been significantly scaled back due to the COVID-19 pandemic. This research study will investigate, based on questionnaires with teens and healthcare providers and interviews with teens, whether pain rehabilitation virtual reality is easy to use and understand, satisfactory to use, and whether it may improve pain, mobility, and function for the teens using the program compared to those doing standard physiotherapy treatment over videoconference.

Detailed Description

Chronic pain affects the lives of 1 in 5 - or 2 million - Canadian children and adolescents and has negative impacts on all aspects of health-related quality of life as well as significant economic costs to families and society. The standard of care for pediatric chronic pain management is an interprofessional biopsychosocial treatment approach, a cornerstone of which is physiotherapy (PT) led functional rehabilitation. Furthermore, lack of access to pain clinics and physiotherapy is an ongoing issue which has been exacerbated by the current COVID-19 pandemic; many ambulatory pediatric chronic pain clinics and community-based physiotherapists have halted appointments, with only a few pivoting to virtual service delivery. Providing care virtually is particularly challenging in this field given the physical and hands-on nature pain physical therapy assessment and treatment. These challenges delay treatment and leave vulnerable youth at risk for severe sequelae without the services they require for recovery.

Virtual reality (VR) can help bridge these gaps in care during and beyond COVID-19 by reducing fear associated with movement. A growing body of research has shown the power of immersive VR for reducing anxiety and managing acute pain via distraction in children and adolescents. While there is emerging evidence for the benefit of VR for treating chronic pain in adults, there is minimal research evaluating VR's effectiveness for reducing pain and improving physical function in children and adolescents with chronic pain. Changes to health service delivery due to the COVID- 19 pandemic confirms the crucial need to develop a comprehensive, engaging, and effective approach to home-based chronic pain rehabilitation. The ability of VR to offer patients with chronic pain access to multi-sensory, 3D, immersive therapeutic experiences, has the potential to break the cycle of pain, fear and activity avoidance from a patient's own home.

This pilot randomized controlled trial (RCT) will: (1) Primary Aim: determine the feasibility of implementing an off-the-shelf VR program and custom VR program (i.e., accrual rates, engagement in therapy sessions, retention rates, technical and practical issues, time to set up and conduct PR-VR, treatment acceptability, outcome evaluation, adverse events and participant satisfaction) and; (2) Secondary Aim: evaluate preliminary effectiveness (estimates of magnitude of effect) of VR interventions compared to the usual care condition (standard virtual PT [SVPT]).

Conditions

Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Off the Shelf VR (PR-VR program + usual care)

• One session per week x 4 weeks; total 4 sessions over 1 month
• PR-VR program (30 min) + Usual care (30 min SVPT)
• Total intervention time = 4 hours
• 10 selected for post-study telephone interview

Group Type: EXPERIMENTAL

Off the Shelf VR

Intervention Type: OTHER

Operates using Oculus quest VR HMD and uses auditory and visual stimuli during the pain rehabilitation treatment. The Off-the-shelf VR program for Oculus Quest VR features a suite of "off-the shelf" applications that can be tailored by the PT and used with participants including. PR-VR sessions will be 30 minutes in total with approximately 20 minutes in the virtual experience and 10 minutes for set-up, screening, instructions, and rest breaks. The Off-the-shelf VR intervention group will also receive 30 minutes of usual care, and Standard Virtual Physiotherapy Treatment (SVPT) during the same appointment, for a total 1-hour usual care session length.

Custom VR (Modified PR-VR program + usual care)

• One session per week x 4 weeks; total 4 sessions over 1 month
• Mod PR-VR program (30 min) + Usual care (30 min SVPT)
• Total intervention time = 4 hours
• 10 selected for post-study telephone interview

Group Type: EXPERIMENTAL

Custom VR

Intervention Type: OTHER

Operates using Oculus Quest VR HMD with PR-VR software developed with two gaming options: Fruity Feet and Space Burgers 2. Game settings are manipulated by the physiotherapist in session to target specific limb movements and intensity and also motivates participants to cycle using a leg ergometer. Motion sensors on the ergometer track the participants revolutions per minute. For participants in this study arm, a leg ergometer (DeskCycle) will be provided to them during the study phase alongside the Actigraph and Oculus Quest HMD. During the 30min VR portion of the session, 20 minutes will be dedicated to gaming and exercise, and 10 minutes dedicated for set up, tear down, and rest breaks. During the 20 minutes gaming time, a minimum of 15 minutes will be dedicated to Custom VR, with 5 minutes for 'free play' where the participant can opt to try an off-the-shelf VR game.

Standard Virtual Physiotherapy Treatment (control; usual care),

• One session per week x 4 weeks; total 4 sessions over 1 month
• Usual care (60 min SVPT)
• Total intervention time = 4 hours

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Off the Shelf VR

Operates using Oculus quest VR HMD and uses auditory and visual stimuli during the pain rehabilitation treatment. The Off-the-shelf VR program for Oculus Quest VR features a suite of "off-the shelf" applications that can be tailored by the PT and used with participants including. PR-VR sessions will be 30 minutes in total with approximately 20 minutes in the virtual experience and 10 minutes for set-up, screening, instructions, and rest breaks. The Off-the-shelf VR intervention group will also receive 30 minutes of usual care, and Standard Virtual Physiotherapy Treatment (SVPT) during the same appointment, for a total 1-hour usual care session length.

Intervention Type: OTHER

Custom VR

Operates using Oculus Quest VR HMD with PR-VR software developed with two gaming options: Fruity Feet and Space Burgers 2. Game settings are manipulated by the physiotherapist in session to target specific limb movements and intensity and also motivates participants to cycle using a leg ergometer. Motion sensors on the ergometer track the participants revolutions per minute. For participants in this study arm, a leg ergometer (DeskCycle) will be provided to them during the study phase alongside the Actigraph and Oculus Quest HMD. During the 30min VR portion of the session, 20 minutes will be dedicated to gaming and exercise, and 10 minutes dedicated for set up, tear down, and rest breaks. During the 20 minutes gaming time, a minimum of 15 minutes will be dedicated to Custom VR, with 5 minutes for 'free play' where the participant can opt to try an off-the-shelf VR game.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. able to speak and read English,

2. 12-18 years old,

3. diagnosed with chronic pain,

4. under active care at the interprofessional out-patient Chronic Pain Clinic at SickKids,

5. on stabilized medication/therapy (no new pain medications/therapies for 1 week prior to the initial PT assessment and treatment) according to medical chart,

6. independently mobile and able to safely engage in physical activity,

7. requiring a minimum of 4 treatments (1-hour sessions of virtual PT) typically once per week,

8. able to have access to an Internet-enabled smartphone, computer or tablet at home (typically once per week for 4 weeks) according to self-report for Zoom for Healthcare visits with PT, and

9. willing to have Zoom for Healthcare visits with PT recorded during the study period and, if selected, individual telephone interview with research assistant (RA) audio recorded following the study period.

Exclusion Criteria

1. visual, auditory or cognitive impairments precluding interaction with the PR-VR intervention and/or control equipment (Internet) as assessed by reviewing the patient's medical chart and consultation with the patient's PT.

2. diagnosis of seizure disorder, history of seizure, or increased risk of seizure.

3. new onset of headaches/migraines, motion sickness, nausea or vomiting or history/symptoms of possible concussion.

4. diagnosis of major, untreated, concurrent psychiatric illness (e.g., depression, anxiety, conversion disorder, PTSD) or personality disorder as assessed by reviewing the patient's medical chart and in consultation by their health care team.

5. currently receiving sedating medications

6. claustrophobia or previous intolerance of virtual reality (e.g. nausea, vomiting, motion sickness, eye strain, false memory formation) as assessed by health care team.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Stinson

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Stinson, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000075493

Identifier Type: -

Identifier Source: org_study_id