CancerNCT05442866
Virtual Reality for Outpatient Cancer Pain Management
A study testing Virtual reality experience for 10 minutes in people with Cancer and Cancer Pain, run by Medstar Health Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer Pain
- What is being tested?
- Virtual reality experience for 10 minutes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Virtual Reality for Outpatient Cancer Pain Management: a Dosing Study
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.
Read the 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.
- Conditions
- Cancer, Cancer Pain
- Being tested
- Virtual reality experience for 10 minutes
- Medical subject headings
- Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality experience for 10 minutesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual reality experience for 10 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 3 weeks (baseline to Study day 21)
Secondary outcomes (5)
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))
Measured: 3 weeks (baseline to Study day 21)
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
Measured: 3 weeks (baseline day 0 to Study day 21)
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))
Measured: 3 weeks (baseline to Study day 21)
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)
Measured: 3 weeks (baseline to Study day 21)
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.)
Measured: Study day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442866
- Sponsor's protocol ID
- STUDY00004928
- Other IDs
- U2CNR014637
- Status last verified
- May 2025
- First submitted
- 23 Jun 2022
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40653577
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Outpatient Cancer Pain Management: a Dosing Study
- ClinicalTrials.gov ID
- NCT05442866
- Acronym / sponsor ID
- STUDY00004928
- Conditions
- Cancer, Cancer Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Posted 25 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality (VR) dosing arm | Experimental | Device: Virtual reality experience for 10 minutesAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality experience for 10 minutesEach 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. | Device | Virtual reality (VR) dosing arm |
Primary outcome
Self-reported Pain Score
Time frame: 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))
5 secondary outcomes
PROMIS Pain Interference Short Form
Time frame: 3 weeks (baseline to Study day 21)
Number of As-needed Opioid Doses Per Day
Time frame: 3 weeks (baseline day 0 to Study day 21)
Satisfaction With Overall Pain Management
Time frame: 3 weeks (baseline to Study day 21)
Satisfaction With Virtual Reality Intervention Over Previous 7 Days
Time frame: 3 weeks (baseline to Study day 21)
Preferences for Virtual Reality Thematic Content (Measured Once, With no Comparison)
Time frame: Study day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40653577Groninger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality experience for 10 minutes in people with Cancer and Cancer Pain, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Pain Score (time frame: 3 weeks (baseline to Study day 21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05442866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.