NCT05442866

Virtual Reality for Outpatient Cancer Pain Management

Completed NA Results posted Last updated 25 May 2025

What this trial tests

NA trial testing Virtual reality experience for 10 minutes in Cancer in 33 participants. Completed in 30 June 2023.

Timeline

1 July 2022

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Medstar Health Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	1 July 2022
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Virtual reality experience for 10 minutes

Conditions studied

• Cancer — all drugs for Cancer →
• Cancer Pain — all drugs for Cancer Pain →

Sponsor

Medstar Health Research Institute

Who can join

18 and older, any sex, with Cancer or Cancer Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Self-reported Pain Score Primary · 3 weeks (baseline to Study day 21)

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))

Group	Value	95% CI
Virtual Reality (VR) Dosing Arm	-0.3	± 0.1

PROMIS Pain Interference Short Form Secondary · 3 weeks (baseline to Study day 21)

Participant completes PROMIS measure of pain interference over last 7 days; PROMIS Pain Interference SF has 6 questions, each with possible scores 1 to 5, making a possible score range between 6 and 30 points - 30 points is the highest level of total pain interference, 6 points is the lowest level of total pain interference. These results report the average change in total Pain Interference SF 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))

Group	Value	95% CI
Virtual Reality (VR) Dosing Arm	-1.5	± 0.4

Number of As-needed Opioid Doses Per Day Secondary · 3 weeks (baseline day 0 to Study day 21)

Participant reports how many as-needed opioid doses used in last 7 days (only for participants prescribed as-needed opioids); results report average number of as-needed opioid doses per day for each study week

prn doses per day after Week 1

Group	Value	95% CI
Virtual Reality (VR) Dosing Arm	1.6	± 2.1

prn doses per day after Week 2

Group	Value	95% CI
Virtual Reality (VR) Dosing Arm	1.5	± 2.0

prn doses per day after Week 3

Group	Value	95% CI
Virtual Reality (VR) Dosing Arm	1.6	± 2.0

Satisfaction With Overall Pain Management Secondary · 3 weeks (baseline to Study day 21)

Participant reports satisfaction with pain management over last 7 days (Likert scale, 0=very unsatisfied, 10=highly satisfied); results report the average change in score of overall satisfaction in pain management 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))

Group	Value	95% CI
Virtual Reality (VR) Dosing Arm	0.7	± 0.2

Satisfaction With Virtual Reality Intervention Over Previous 7 Days Secondary · 3 weeks (baseline to Study day 21)

Participant reports satisfaction with virtual reality intervention over last 7 days (Likert scale, 0=very unsatisfied, 10=highly satisfied)

Group	Value	95% CI
Virtual Reality (VR) Dosing Arm	9.5	± 2

Preferences for Virtual Reality Thematic Content (Measured Once, With no Comparison) Secondary · Study day 21

Participant chooses preferred visual thematic content (as many as preferred) from photos of different images (e.g. beachscape, rain forest, luxury auto, monastery, etc.)

Group	Value	95% CI
Virtual Reality (VR) Dosing Arm	14
Virtual Reality (VR) Dosing Arm	7
Virtual Reality (VR) Dosing Arm	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Each participant was enrolled and followed by the study coordinator for a maximum period of 3 weeks (from enrollment and baseline measures to final measure collection). Because virtual reality has never been shown to have adverse events that last longer than the duration of the virtual reality device use, this time frame was most appropriate for adverse event data collection.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Virtual Reality (VR) Dosing Arm

Serious: 2/33 (6%)

Deaths: 1/33

Serious adverse events (2 terms)

Reaction	System	Virtual Reality (VR) Dosin…
Hospitalized	Infections and infestations	—
Surgery	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—

Other adverse events (2 terms — click to expand)

Reaction	System	Virtual Reality (VR) Dosin…
Headache	General disorders	—
Dizziness	Nervous system disorders	—

Most-reported serious reactions: Hospitalized, Surgery.

Data from ClinicalTrials.gov NCT05442866 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Virtual reality for outpatient management of cancer pain: a pilot dosing study.
   Groninger H, Violanti D, McPherson ML, Hopkins K, et al · · 2025 · PMID 40653577 · DOI 10.1007/s00520-025-09723-z