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Virtual Reality for Outpatient Cancer Pain Management

Virtual Reality for Outpatient Cancer Pain Management: a Dosing Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05442866
Enrollment
33
Registered
2022-07-05
Start date
2022-07-01
Completion date
2023-06-30
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Cancer Pain

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.

Detailed description

The purpose of this a non-randomized, unblinded dose-titration study to evaluate the impact of virtual reality therapy on mitigating moderate to severe pain in outpatients living with cancer. Outpatients receiving cancer care at the Washington Cancer Institute (Washington, DC) will be considered for enrollment in this study if able to provide consent, at least 18 years old, and report moderate-severe pain (at least 4 out of 10 where pain is rated on a Likert scale between zero and 10) in the previous 7 days as a result of either cancer or cancer treatment. Palliative care consultation and/or referral to palliative care is not required for eligibility or participation. Additionally, participation will not be limited by whether subjects are receiving specific cancer-directed therapies at the time of enrollment. Subjects will be excluded if they 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, or are currently enrolled in a palliative care or pain management study. Subjects will also be excluded if they have limited vision or vision defects that are not corrected with prescription eyeglasses, or if participants are unable or do not wish to wear required corrective eyeglasses with the VR headset. Informed consent will be conducted before enrolling each patient. This is a non-randomized, unblinded dose-titration study. 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. Because of the nature of the compared interventions, subjects and researchers cannot be blinded to intervention. Our primary outcome measure will determine the impact of VR on self-reported pain score in the last week (numeric rating scale, collected weekly). Self-reported pain experience remains the standard for clinical pain research. Secondary outcomes will measure pain interference (PROMIS Pain Interference Short Form, collected weekly), as-needed opioid use for patients taking opioid analgesics at the time of enrollment (self-reported using medication administration form), satisfaction with VR intervention and overall pain management (collected weekly), and survey of preferences for VR thematic content (collected after Week 4). Following consent, subjects will complete baseline outcome assessments including self-reported pain score in the last week, the PROMIS Pain Interference Short Form, as-needed opioid use in the last week if applicable, and satisfaction with overall pain management. Subjects will then be provided with a VR headset and paired Touch controllers to bring home for the duration of the study and instructions on the frequency of use for each week. A member of the research will educate the patient on the technology and assure comfort with use. The research study coordinator will contact patients by phone at the end of each week to confirm dates and duration of use as specified by the study protocol, collect self-reported pain score in the last week, the PROMIS Pain Interference Short Form, as-needed opioid use in the last week if applicable, and satisfaction with the VR intervention and overall pain management. Additionally, participants will be surveyed on preferences for VR thematic content at the end of Week 3.

Interventions

DEVICEVirtual reality experience for 10 minutes

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.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Medstar Health Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Self-reported Pain Score3 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))

Secondary

MeasureTime frameDescription
PROMIS Pain Interference Short Form3 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))
Number of As-needed Opioid Doses Per Day3 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
Satisfaction With Overall Pain Management3 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))
Satisfaction With Virtual Reality Intervention Over Previous 7 Days3 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)
Preferences for Virtual Reality Thematic Content (Measured Once, With no Comparison)Study day 21Participant chooses preferred visual thematic content (as many as preferred) from photos of different images (e.g. beachscape, rain forest, luxury auto, monastery, etc.)

Countries

United States

Participant flow

Participants by arm

ArmCount
Virtual Reality (VR) Dosing Arm
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. Virtual reality experience for 10 minutes: 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.
33
Total33

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath1
Overall StudyLost to Follow-up9
Overall StudyProtocol Violation1

Baseline characteristics

CharacteristicVirtual Reality (VR) Dosing Arm
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
5 Participants
Age, Categorical
Between 18 and 65 years
28 Participants
Age, Continuous55 years
STANDARD_DEVIATION 11
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
30 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
3 Participants
Region of Enrollment
United States
33 participants
Sex: Female, Male
Female
24 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
1 / 33
other
Total, other adverse events
2 / 33
serious
Total, serious adverse events
2 / 33

Outcome results

Primary

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))

Time frame: 3 weeks (baseline to Study day 21)

ArmMeasureValue (MEAN)Dispersion
Virtual Reality (VR) Dosing ArmSelf-reported Pain Score-0.3 score on a scale, measured each weekStandard Error 0.1
Secondary

Number of As-needed Opioid Doses Per Day

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

Time frame: 3 weeks (baseline day 0 to Study day 21)

Population: Patients taking as needed opioids who completed all three study weeks

ArmMeasureGroupValue (MEAN)Dispersion
Virtual Reality (VR) Dosing ArmNumber of As-needed Opioid Doses Per Dayprn doses per day after Week 11.6 prn doses per dayStandard Deviation 2.1
Virtual Reality (VR) Dosing ArmNumber of As-needed Opioid Doses Per Dayprn doses per day after Week 21.5 prn doses per dayStandard Deviation 2
Virtual Reality (VR) Dosing ArmNumber of As-needed Opioid Doses Per Dayprn doses per day after Week 31.6 prn doses per dayStandard Deviation 2
Secondary

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

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

Time frame: Study day 21

Population: Participants who completed all three weeks of study period

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Virtual Reality (VR) Dosing ArmPreferences for Virtual Reality Thematic Content (Measured Once, With no Comparison)Prefer realistic VR14 Participants
Virtual Reality (VR) Dosing ArmPreferences for Virtual Reality Thematic Content (Measured Once, With no Comparison)Prefer simulated VR7 Participants
Virtual Reality (VR) Dosing ArmPreferences for Virtual Reality Thematic Content (Measured Once, With no Comparison)Prefer both/mix1 Participants
Secondary

PROMIS Pain Interference Short Form

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))

Time frame: 3 weeks (baseline to Study day 21)

ArmMeasureValue (MEAN)Dispersion
Virtual Reality (VR) Dosing ArmPROMIS Pain Interference Short Form-1.5 score on a scale, measured each weekStandard Error 0.4
Secondary

Satisfaction With Overall Pain Management

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))

Time frame: 3 weeks (baseline to Study day 21)

ArmMeasureValue (MEAN)Dispersion
Virtual Reality (VR) Dosing ArmSatisfaction With Overall Pain Management0.7 score on a scale, measured each weekStandard Error 0.2
Secondary

Satisfaction With Virtual Reality Intervention Over Previous 7 Days

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

Time frame: 3 weeks (baseline to Study day 21)

Population: Patients who completed all three weeks of study completed this survey question

ArmMeasureValue (MEAN)Dispersion
Virtual Reality (VR) Dosing ArmSatisfaction With Virtual Reality Intervention Over Previous 7 Days9.5 score on a scaleStandard Error 2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026