Virtual reality headset tested for abdominal pain in digestive cancer patients
Tests virtual reality headsets for abdominal pain in adults with digestive tract cancers.
Key facts
- Who runs it
- Cedars-Sinai Medical Center
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Registry title
- Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
- Status
- Recruiting
- People taking part
- 360 people, planned
- Started
- 5 Oct 2021
- Expected to end
- 16 Apr 2027
- Type of study
- Interventional, 3 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- PICO G2 4k
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a cancer of the digestive tract who have clear belly pain from it. It tests virtual reality headsets for pain.
- Age
- 18 Years to 99 Years
- Sex
- All sexes can join.
- Disease stage
- A primary cancer of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine or stomach, with no plan for surgery to remove it during the study. Belly pain must score at least 5 points above the nationally normed score on the NIH PROMIS GI Pain Scale.
Main reasons for not taking part
- A condition that interferes with VR use, such as seizures, facial injury or visual impairment
- Cognitive impairment that affects taking part in the study
- Brain metastases
- Expected survival of less than 3 months, according to the treating oncologist
- Cannot read and write in English
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period
- Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible
- Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score
- Ability to read and write in English
Who cannot take part
- Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments
- Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible
- Have brain metastases
- Have a prognosis of <3 months from the time of enrollment per treating oncologist
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Where in United States
- Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Karisma Kothari, MDTaking people
About the trial
What the trial wants to find out
Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain.
Read full original descriptionShow less
To address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.
The 3 groups in the trial
- Virtual Reality Program ATreatment being tested
This arm will include software that provides immersive skills-based content for pain reduction.
Treatment: PICO G2 4k
- Virtual Reality Program BTreatment being tested
This arm will include software that provides immersive distraction based content for pain reduction.
Treatment: PICO G2 4k
- Virtual Reality Program CSham treatment, for comparison
This arm will include software that provides nonimmersive distraction based content for pain reduction.
Treatment: PICO G2 4k
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
- Plain-language title
- Virtual reality headset tested for abdominal pain in digestive cancer patientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04907643, who can take part
- Record updated
- 12 November 2026