NCT04556747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

September 15, 2020

Last Update Submit

September 23, 2021

Conditions

Pain, PostoperativePainAnxiety

Outcome Measures

Primary Outcomes (16)

  • 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

    Before 10 minute VR session.

  • 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

    Immediately after 10 minute VR session.

  • 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

    15 minutes after 10 minute VR session.

  • 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

    30 minutes after 10 minute VR session.

  • 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

    Before 10 minute VR session.

  • 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

    Immediately after 10 minute VR session.

  • 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

    15 minutes after 10 minute VR session.

  • 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

    30 minutes after 10 minute VR session.

  • 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

    Before 10 minute VR session.

  • 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

    Immediately after 10 minute VR session.

  • 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

    15 minutes after 10 minute VR session.

  • 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

    30 minutes after 10 minute VR session.

  • 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

    Before 10 minute VR session

  • 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

    Immediately after 10 minute VR session

  • 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

    15 minutes after 10 minute VR session

  • 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

    30 minutes after 10 minute VR session

Secondary Outcomes (2)

  • Role of anxiety on changes in pain

    One time prior to study visit

  • Role of pain catastrophizing

    One time prior to study visit

Study Arms (2)

VR - Distraction

OTHER
Other: VR - Distraction

VR - Biofeedback

OTHER
Other: VR - Biofeedback

Interventions

VR - DistractionOTHER

Participants will be instructed to use any application.

VR - Distraction
VR - BiofeedbackOTHER

Participants will be instructed to use the Mindful Aurora application.

VR - Biofeedback

Eligibility Criteria

Age7 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

  • 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.

    PMID: 34048358DERIVED

MeSH Terms

Conditions

Pain, PostoperativePainAnxiety Disorders

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsMental Disorders

Study Officials

  • Vanessa Olbrecht, MD

    Cincinnati Childrens Hospital Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 21, 2020

Study Start

September 1, 2018

Primary Completion

March 11, 2020

Study Completion

March 11, 2020

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

This information will be made available upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will become available upon publication. All data will be deidentified.

Locations

US(1)