NCT05442866

Brief Summary

This is a non-randomized, unblinded dose-titration study to evaluate different "doses" of virtual reality to impact moderate-to-severe pain in patients living with cancer. After consenting to participate, in addition to usual pharmacologic pain management, participants will receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable cancer

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

First Submitted

Initial submission to the registry

June 23, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

June 23, 2022

Results QC Date

November 18, 2024

Last Update Submit

May 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-reported Pain Score

    Participant reports average pain (Likert scale 0-10, 0=pain, 10=worst pain) over last 7 days; results report the average change in self-reported pain score per study week, from baseline (Study day 0) to each subsequent measurement (measured on Study day 7 (week 1), Study day 14 (week 2), Study day 21(week 3))

    3 weeks (baseline to Study day 21)

Secondary Outcomes (5)

  • PROMIS Pain Interference Short Form

    3 weeks (baseline to Study day 21)

  • Number of As-needed Opioid Doses Per Day

    3 weeks (baseline day 0 to Study day 21)

  • Satisfaction With Overall Pain Management

    3 weeks (baseline to Study day 21)

  • Satisfaction With Virtual Reality Intervention Over Previous 7 Days

    3 weeks (baseline to Study day 21)

  • Preferences for Virtual Reality Thematic Content (Measured Once, With no Comparison)

    Study day 21

Study Arms (1)

Virtual reality (VR) dosing arm

EXPERIMENTAL

All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant.

Device: Virtual reality experience for 10 minutes

Interventions

Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position.

Virtual reality (VR) dosing arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and older
  • Have diagnosis of cancer (any type)
  • Report moderate-severe pain related to cancer or cancer treatment at baseline
  • Able to provide consent

You may not qualify if:

  • Already use VR for personal use
  • Have intractable nausea/vomiting, history of motion sickness, history of seizures or epilepsy
  • Have cranial structure abnormalities that prevent use of VR headset
  • Currently enrolled in a palliative care or pain management study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

  • Groninger H, Violanti D, McPherson ML, Hopkins K, Carr AL, Hurtado M, Mete M. Virtual reality for outpatient management of cancer pain: a pilot dosing study. Support Care Cancer. 2025 Jul 14;33(8):690. doi: 10.1007/s00520-025-09723-z.

MeSH Terms

Conditions

NeoplasmsCancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Hunter Groninger
Organization
MedStar Health Research Institute

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2022

First Posted

July 5, 2022

Study Start

July 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

May 25, 2025

Results First Posted

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations