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VR-PAT for Pain and Anxiety Management During Pediatric Dermatologic Laser Procedures

Primary Purpose

Procedural Anxiety, Procedural Pain

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

VR-PAT

About this trial

This is an interventional supportive care trial for Procedural Anxiety focused on measuring Laser, Dermatology, Virtual Reality, VR

Eligibility Criteria

5 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: dermatology patients (5+ years) who are undergoing first laser procedure at the Nationwide Children's Outpatient Laser have a legal guardian present for patients less than 18 years old for the procedure (for informed consent) can communicate orally Exclusion Criteria: any wounds that may interfere with study procedures usage of a diode laser (VR safety has not been established yet) vision, hearing, or cognitive/motor impairments preventing valid administration of study measures history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras minors in foster care unable to communicate in English pregnant women prisoners

Sites / Locations

Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VR-PAT

Control

Arm Description

Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game.

Participant wears the Pico Neo 3 Pro Eye headset to protect eyes, but it is not turned on.

Outcomes

Primary Outcome Measures

Change in procedural pain

0-10 Numerical Rating Scale (NRS) (self-reported and caregiver-reported (if <18 years)), 0(min)-10(max), with higher score indicating worse pain. Asked for worst pain, average pain, and time spent thinking about pain.

Change in procedural anxiety

Modified Yale Preoperative Anxiety Scale (mYPAS) (observed by researcher), 23.33(min)-100(max), with higher scores denoting higher levels of anxiety.

Secondary Outcome Measures

Self-reported VR experience

0-10 Numerical Rating Scale (NRS) (self-reported - VR-PAT arm only), 0(min)-10(max), with higher score meaning better outcome. Asked for degree of realism, pleasure, and satisfaction with VR.

Nurse-reported utility

Binary (Yes/No) questions of whether the nurse found VR-PAT to be helpful and easy to use during the procedure.

Full Information

NCT ID

NCT05645224

First Posted

November 30, 2022

Last Updated

January 30, 2023

Sponsor

Nationwide Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05645224

Brief Title

VR-PAT for Pain and Anxiety Management During Pediatric Dermatologic Laser Procedures

Official Title

Pilot Feasibility Clinical Trial of Virtual Reality for Pain Management During Repeated Pediatric Laser Procedures

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

January 9, 2023 (Actual)

Primary Completion Date

December 30, 2024 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nationwide Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will assess the feasibility and efficacy of our Virtual Reality Pain Alleviation Therapy (VR-PAT) for pain management during pediatric and young adult outpatient laser procedures and evaluate the impact of VR use on reducing anxiety in patients undergoing dermatologic laser procedures. The investigators hypothesize that patients using VR-PAT will report less pain and anxiety during the laser procedure than patients who do not play the game.

Detailed Description

In this two-group crossover randomized clinical trial, patients will be randomly assigned to either the VR-PAT intervention group or control group (same VR google without game) at the first laser procedure and will then cross-over to the alternative group for the second laser procedure. Survey questions to assess pain and anxiety and control for confounding factors will be asked before and after each procedure.

6. Conditions and Keywords

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

Procedural Anxiety, Procedural Pain

Keywords

Laser, Dermatology, Virtual Reality, VR

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Participants will be randomly assigned to either the intervention group (VR-PAT) or the control group (same VR google without game) at the first laser procedure and will then cross-over to the alternative group for the second laser procedure.

Masking

Investigator

Masking Description

Researcher conducting the post-procedural survey is blinded to the group assignment

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VR-PAT

Arm Type

Experimental

Arm Description

Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game.

Arm Title

Control

Arm Type

No Intervention

Arm Description

Participant wears the Pico Neo 3 Pro Eye headset to protect eyes, but it is not turned on.

Intervention Type

Other

Intervention Name(s)

VR-PAT

Intervention Description

Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device

Primary Outcome Measure Information:

Title

Change in procedural pain

Description

Time Frame

Assessed immediately following each laser procedure

Title

Change in procedural anxiety

Description

Modified Yale Preoperative Anxiety Scale (mYPAS) (observed by researcher), 23.33(min)-100(max), with higher scores denoting higher levels of anxiety.

Time Frame

Assessed at 3 time points (prior to entering procedure room, prior to the procedure, and immediately following the procedure) for each laser procedure

Secondary Outcome Measure Information:

Title

Self-reported VR experience

Description

0-10 Numerical Rating Scale (NRS) (self-reported - VR-PAT arm only), 0(min)-10(max), with higher score meaning better outcome. Asked for degree of realism, pleasure, and satisfaction with VR.

Time Frame

Immediately following laser procedure in VR-PAT group

Title

Nurse-reported utility

Description

Binary (Yes/No) questions of whether the nurse found VR-PAT to be helpful and easy to use during the procedure.

Time Frame

Immediately following laser procedure in VR-PAT group

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry Xiang, MD, MPH, PhD, MBA

Organizational Affiliation

Nationwide Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nationwide Children's Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

VR-PAT for Pain and Anxiety Management During Pediatric Dermatologic Laser Procedures

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