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FOREVR Peds VR Pilot

Primary Purpose

Pain, Postoperative, Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR - Distraction
VR - Biofeedback
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Postoperative

Eligibility Criteria

7 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 7to 21 years
  • Able to read, understand, and speak English
  • Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service (acute postoperative pain cohort); patients presenting in Same Day Surgery for peripheral IV placement or patients in the CBDI clinic presenting for peripheral IV placement or Port accessing (vascular access cohort); or patients admitted to CCHMC on the Medical Pain Service (chronic pain cohort), or sickle cell patients not on the MPS list.
  • Patients who have undergone bone marrow transplantation or receiving chemotherapy experiencing pain from mucositis

Exclusion Criteria:

  • Outside the age range (< 7 or > 21 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 glasses, such as surgeries of the head and neck

Sites / Locations

  • Cincinnati Childrens Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

VR - Distraction

VR - Biofeedback

Arm Description

Outcomes

Primary Outcome Measures

Effect of VR-distraction on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Distraction on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Distraction on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Distraction on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Distraction on pain
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-Distraction on pain
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-Distraction on pain
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-Distraction on pain
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-Biofeedback on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Biofeedback on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Biofeedback on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Biofeedback on anxiety
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Biofeedback on pain
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-Biofeedback on pain
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-Biofeedback on pain
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-Biofeedback on pain
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain

Secondary Outcome Measures

Role of anxiety on changes in pain
Participants will complete a questionnaire regarding anxiety
Role of pain catastrophizing
Participants will complete a questionnaire regarding pain

Full Information

First Posted
September 15, 2020
Last Updated
September 23, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT04556747
Brief Title
FOREVR Peds VR Pilot
Official Title
Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients (FOREVR Peds Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
March 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the feasibility and acceptability of using immersive virtual reality technologies to impact clinical outcomes (e.g., pain and anxiety) and medication utilization (e.g., narcotics) in pediatric patients with acute and chronic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain, Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR - Distraction
Arm Type
Other
Arm Title
VR - Biofeedback
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
VR - Distraction
Intervention Description
Participants will be instructed to use any application.
Intervention Type
Other
Intervention Name(s)
VR - Biofeedback
Intervention Description
Participants will be instructed to use the Mindful Aurora application.
Primary Outcome Measure Information:
Title
Effect of VR-distraction on anxiety
Description
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Time Frame
Before 10 minute VR session.
Title
Effect of VR-Distraction on anxiety
Description
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Time Frame
Immediately after 10 minute VR session.
Title
Effect of VR-Distraction on anxiety
Description
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Time Frame
15 minutes after 10 minute VR session.
Title
Effect of VR-Distraction on anxiety
Description
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Time Frame
30 minutes after 10 minute VR session.
Title
Effect of VR-Distraction on pain
Description
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Time Frame
Before 10 minute VR session.
Title
Effect of VR-Distraction on pain
Description
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Time Frame
Immediately after 10 minute VR session.
Title
Effect of VR-Distraction on pain
Description
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Time Frame
15 minutes after 10 minute VR session.
Title
Effect of VR-Distraction on pain
Description
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Time Frame
30 minutes after 10 minute VR session.
Title
Effect of VR-Biofeedback on anxiety
Description
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Time Frame
Before 10 minute VR session.
Title
Effect of VR-Biofeedback on anxiety
Description
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Time Frame
Immediately after 10 minute VR session.
Title
Effect of VR-Biofeedback on anxiety
Description
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Time Frame
15 minutes after 10 minute VR session.
Title
Effect of VR-Biofeedback on anxiety
Description
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Time Frame
30 minutes after 10 minute VR session.
Title
Effect of VR-Biofeedback on pain
Description
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Time Frame
Before 10 minute VR session
Title
Effect of VR-Biofeedback on pain
Description
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Time Frame
Immediately after 10 minute VR session
Title
Effect of VR-Biofeedback on pain
Description
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Time Frame
15 minutes after 10 minute VR session
Title
Effect of VR-Biofeedback on pain
Description
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Time Frame
30 minutes after 10 minute VR session
Secondary Outcome Measure Information:
Title
Role of anxiety on changes in pain
Description
Participants will complete a questionnaire regarding anxiety
Time Frame
One time prior to study visit
Title
Role of pain catastrophizing
Description
Participants will complete a questionnaire regarding pain
Time Frame
One time prior to study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 7to 21 years Able to read, understand, and speak English Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service (acute postoperative pain cohort); patients presenting in Same Day Surgery for peripheral IV placement or patients in the CBDI clinic presenting for peripheral IV placement or Port accessing (vascular access cohort); or patients admitted to CCHMC on the Medical Pain Service (chronic pain cohort), or sickle cell patients not on the MPS list. Patients who have undergone bone marrow transplantation or receiving chemotherapy experiencing pain from mucositis Exclusion Criteria: Outside the age range (< 7 or > 21 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 glasses, such as surgeries of the head and neck
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Olbrecht, MD
Organizational Affiliation
Cincinnati Childrens Hospital Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
This information will be made available upon request
IPD Sharing Time Frame
Data will become available upon publication. All data will be deidentified.
Citations:
PubMed Identifier
34048358
Citation
Olbrecht VA, O'Conor KT, Williams SE, Boehmer CO, Marchant GW, Glynn SM, Geisler KJ, Ding L, Yang G, King CD. Guided Relaxation-Based Virtual Reality for Acute Postoperative Pain and Anxiety in a Pediatric Population: Pilot Observational Study. J Med Internet Res. 2021 Jul 12;23(7):e26328. doi: 10.2196/26328.
Results Reference
derived

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FOREVR Peds VR Pilot

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