Pain, PostoperativeFOREVR PedsNCT04351776
Virtual Reality and Pain
A study testing VR-Biofeedback, VR-Distraction and 360 Video in people with Pain, Postoperative and Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Determine the impact of VR-Biofeedback, VR-distraction, and 360 video on pain and medication utilization in patients undergoing surgery; determine the role of anxiety and pain catastrophizing on changes in pain following VR-BF in patients undergoing surgery. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pain, Postoperative, Pain, Anxiety Postoperative
- What is being tested?
- VR-Biofeedback, VR-Distraction and 360 Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2020to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 8 - 18 years
- Able to read, understand and speak English
- Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service
Who cannot join
- Outside the age range (< 8 or > 18 years)
- History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
- History of vertigo, dizziness, and/or seizure disorder
- Conditions that would preclude the application of the VR headset, such as surgeries of the head and neck
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients: a Randomized Clinical Trials
Determine the impact of VR-Biofeedback, VR-distraction, and 360 video on pain and medication utilization in patients undergoing surgery; determine the role of anxiety and pain catastrophizing on changes in pain following VR-BF in patients undergoing surgery.
- Conditions
- Pain, Postoperative, Pain, Anxiety Postoperative
- Being tested
- VR-Biofeedback, VR-Distraction, 360 Video
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-BiofeedbackOther
Participants will be instructed to use the Mindful Aurora application
VR-DistractionOther
Participants will be instructed to use one of three applications
360 VideoOther
Participants will be instructed which video to view
| Study group | Role | What they receive |
|---|---|---|
| VR-Biofeedback | Other | Not described Receives: Other: VR-Biofeedback |
| VR-Distraction | Other | Not described Receives: Other: VR-Distraction |
| 360 Video | Other | Not described Receives: Other: 360 Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of VR-biofeedback on pain
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
Measured: Postoperatively 24 - 90 hours.
Effect of VR-distraction on pain
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
Measured: Postoperatively 24 - 90 hours.
Effect of 360 video on pain
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
Measured: Postoperatively 24 - 90 hours.
Secondary outcomes (11)
Effect of VR-biofeedback on anxiety
Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Measured: Before 10 minute VR session.
Effect of VR-biofeedback on anxiety
Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Measured: After 10 minute VR session. Anxiety will be rated using a visual analog scale.
Effect of VR-biofeedback on medication use
Medications used will be collected
Measured: Duration of hospital stay up to 30 days after discharge
Effect of VR-distraction on anxiety
Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Measured: Before 10 minute VR session.
Effect of VR-distraction on anxiety
Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Measured: After 10 minute VR session.
Effect of VR-distraction on medication use
Medications used will be collected
Measured: Duration of hospital stay up to 30 days after discharge
Effect of 360 video on anxiety
Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Measured: Before 10 minute VR session.
Effect of 360 video on anxiety
Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Measured: After 10 minute VR session.
Effect of 360 video on medication use
Medications used will be collected
Measured: Duration of hospital stay up to 30 days after discharge
Role of anxiety on changes in pain
Participants will complete a questionnaire regarding anxiety
Measured: One time prior to study visit
Role of pain catastrophizing
Participants will complete a questionnaire regarding pain
Measured: One time prior to study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start10 Jul 2020
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 90 participants assigned to one of three groups (30 participants for each group). VR- Biofeedback, VR-Distraction, 360 Video
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Walter, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351776
- Sponsor's protocol ID
- 2019-1090
- Acronym
- FOREVR Peds
- Status last verified
- Aug 2023
- First submitted
- 3 Apr 2020
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This information will be made available upon request.
Publications
Olbrecht VA, Williams SE, O'Conor KT, Boehmer CO, Marchant GW, Glynn SM, Geisler KJ, Ding L, Yang G, King CD. Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). BMJ Open. 2020 Dec 30;10(12):e040295. doi: 10.1136/bmjopen-2020-040295.
PubMed 33380482
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients: a Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT04351776
- Acronym / sponsor ID
- FOREVR Peds / 2019-1090
- Conditions
- Pain, Postoperative, Pain, Anxiety Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the impact of VR-Biofeedback, VR-distraction, and 360 video on pain and medication utilization in patients undergoing surgery; determine the role of anxiety and pain catastrophizing on changes in pain following VR-BF in patients undergoing surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 90 participants assigned to one of three groups (30 participants for each group). VR- Biofeedback, VR-Distraction, 360 Video
| Arm | Type | Receives |
|---|---|---|
| VR-Biofeedback | Other | Other: VR-Biofeedback |
| VR-Distraction | Other | Other: VR-Distraction |
| 360 Video | Other | Other: 360 Video |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Ages 8 - 18 years
- Able to read, understand and speak English
- Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service
Key exclusion criteria (4 listed)
- Outside the age range (< 8 or > 18 years)
- History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
- History of vertigo, dizziness, and/or seizure disorder
- Conditions that would preclude the application of the VR headset, such as surgeries of the head and neck
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-BiofeedbackParticipants will be instructed to use the Mindful Aurora application | Other | VR-Biofeedback |
| VR-DistractionParticipants will be instructed to use one of three applications | Other | VR-Distraction |
| 360 VideoParticipants will be instructed which video to view | Other | 360 Video |
Primary outcome
Effect of VR-biofeedback on pain
Time frame: Postoperatively 24 - 90 hours.
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
Effect of VR-distraction on pain
Time frame: Postoperatively 24 - 90 hours.
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
Effect of 360 video on pain
Time frame: Postoperatively 24 - 90 hours.
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
11 secondary outcomes
Effect of VR-biofeedback on anxiety
Time frame: Before 10 minute VR session.
Effect of VR-biofeedback on anxiety
Time frame: After 10 minute VR session. Anxiety will be rated using a visual analog scale.
Effect of VR-biofeedback on medication use
Time frame: Duration of hospital stay up to 30 days after discharge
Effect of VR-distraction on anxiety
Time frame: Before 10 minute VR session.
Effect of VR-distraction on anxiety
Time frame: After 10 minute VR session.
Effect of VR-distraction on medication use
Time frame: Duration of hospital stay up to 30 days after discharge
Effect of 360 video on anxiety
Time frame: Before 10 minute VR session.
Effect of 360 video on anxiety
Time frame: After 10 minute VR session.
Effect of 360 video on medication use
Time frame: Duration of hospital stay up to 30 days after discharge
Role of anxiety on changes in pain
Time frame: One time prior to study visit
Role of pain catastrophizing
Time frame: One time prior to study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 33380482Olbrecht VA, Williams SE, O'Conor KT, Boehmer CO, Marchant GW, Glynn SM, Geisler KJ, Ding L, Yang G, King CD. Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). BMJ Open. 2020 Dec 30;10(12):e040295. doi: 10.1136/bmjopen-2020-040295.
- Individual participant dataSharing planned: Yes. This information will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Walter, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-Biofeedback, VR-Distraction and 360 Video in people with Pain, Postoperative and Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 31 Aug 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of VR-biofeedback on pain (time frame: Postoperatively 24 - 90 hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04351776, which also lists 1 linked publication.
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 31 Aug 2023.