Intensive Care Unit ICUGAMERSNCT07234201
Virtual Reality Use for ICU Mobility
A study testing Nurse driven virtual reality mobility session in people with Intensive Care Unit ICU, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to explore if Virtual Reality (VR) helps patients in the Intensive Care Unit (ICU) move more and feel better. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit ICU
- What is being tested?
- Nurse driven virtual reality mobility session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- English speaking
- Adults age 18 or greater
- ICU stay greater or equal to 3 days
- Limited mobility
Who cannot join
- Pregnancy
- Special enteric contact isolation
- Blindness
- History of seizure or vertigo
- Intubated and sedated
- ICU delirium
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Anna Mall, MSN, 984-227-0106, anna.mall@duke.edu
About this study
Official title: Designing a Virtual Reality Intervention to Improve Physical and Psychological Health in Intensive Care Units
The purpose of this study is to explore if Virtual Reality (VR) helps patients in the Intensive Care Unit (ICU) move more and feel better.
- Conditions
- Intensive Care Unit ICU
- Being tested
- Nurse driven virtual reality mobility session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse driven virtual reality mobility sessionOther
Participants will use the virtual reality device to play the game that will facilitate movement of arms, shoulders and trunk to music, similar to dancing or Tai-Chi.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard mobility care |
| VR intervention | Other | Virtual Reality Receives: Other: Nurse driven virtual reality mobility session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Increased Mobility
Measured: 10 days or ICU discharge, which ever comes first
Secondary outcomes (1)
Number of participants with Improved psychosocial well-being
Measured: 10 days or ICU discharge, which ever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Dec 2025
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit ICUStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Mall, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234201
- Sponsor's protocol ID
- PRO00116448_1
- Acronym
- GAMERS
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing a Virtual Reality Intervention to Improve Physical and Psychological Health in Intensive Care Units
- ClinicalTrials.gov ID
- NCT07234201
- Acronym / sponsor ID
- GAMERS / PRO00116448_1
- Conditions
- Intensive Care Unit ICU
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore if Virtual Reality (VR) helps patients in the Intensive Care Unit (ICU) move more and feel better.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard mobility care |
| VR intervention | Other | Other: Nurse driven virtual reality mobility sessionVirtual Reality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- Adults age 18 or greater
- ICU stay greater or equal to 3 days
- Limited mobility
Key exclusion criteria (6 listed)
- Pregnancy
- Special enteric contact isolation
- Blindness
- History of seizure or vertigo
- Intubated and sedated
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 |
|---|---|---|
| Nurse driven virtual reality mobility sessionParticipants will use the virtual reality device to play the game that will facilitate movement of arms, shoulders and trunk to music, similar to dancing or Tai-Chi. | Other | VR intervention |
Primary outcome
Number of participants with Increased Mobility
Time frame: 10 days or ICU discharge, which ever comes first
1 secondary outcome
Number of participants with Improved psychosocial well-being
Time frame: 10 days or ICU discharge, which ever comes first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- 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.
Anna Mall principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse driven virtual reality mobility session in people with Intensive Care Unit ICU, run by Duke University 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 6 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Mall (984-227-0106, anna.mall@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Increased Mobility (time frame: 10 days or ICU discharge, which ever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2026.