MobilityGAMERSNCT06797895
Designing a Virtual Reality Intervention to Improve Physical and Psychological Health in Intensive Care Units
A study testing VR assisted mobility in people with Mobility and ICU, run by Duke University at 1 site in United States.
Trial summary
The goal of this study is to explore if Virtual Reality helps patients in the cardiothoracic ICU move more and feel better. Participants will be asked to answer a survey about anxiety, depression, and loneliness. The study team will teach participants how to use the VR device and how to play the game. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mobility, ICU, Heart Surgery
- What is being tested?
- VR assisted mobility
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to Aug 2026
- 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
- Adult
- English speaking
- 3+ days ICU admission with limited mobility
Who cannot join
- Pregnancy
- Blind/severe visual impairment
- History of seizures
- Intubation/sedation
- Special enteric contact isolation
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
The goal of this study is to explore if Virtual Reality helps patients in the cardiothoracic ICU move more and feel better. Participants will be asked to answer a survey about anxiety, depression, and loneliness. The study team will teach participants how to use the VR device and how to play the game. Participants will play the game at least once per day, but can play as much as they want. Study activities include nurse facilitated patient use of VR applications that involve upper body movement (e.g., using arms and hands to dance or hit objects in a virtual reality environment).
Read the detailed description
Patients who survive critical illness and prolonged intensive care unit (ICU) stays are at risk for debilitating physical (deconditioning, skin injury, and infection), and mental health impairment (depression, anxiety and PTSD). Early mobility improves these deleterious outcomes but is challenging to implement in patients on prolonged bedrest. The purpose of this study is to compare a nurse-led implementation of a Virtual Reality (VR) experience in the Cardio-Thoracic Intensive Care Unit (CT-ICU) to standard of care to improve mobility for patients on prolonged bedrest. The investigators hypothesize that nurse-led implementation of VR experiences in the CT-ICU, in combination with engineering-led patient-centered customization of the VR applications, will improve both the physical and psychological function of ICU patients on prolonged bedrest.
- Conditions
- Mobility, ICU, Heart Surgery, Nursing
- Being tested
- VR assisted mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR assisted mobilityBehavioural
Commercially-based VR experience used to help move upper extremities to music, similar to dancing or Tai-Chi.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) intervention | Other | Cohort for observing the effects of the VR intervention on ICU mobility. Receives: Behavioral: VR assisted mobility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by nursing time required
For each participant, the total nursing time spent (in minutes) setting up and delivering the intervention will be recorded.
Measured: up to 6 months
Secondary outcomes (10)
Usability as measured by patient-reported ease of playing the game
Usability: Using a 5-point Likert scale (0- very difficult to 5- very easy; higher is better outcome), participants will be surveyed after the intervention period to assess ease of playing the game.
Measured: up to 6 months
Usability as measured by patient-reported ease of hand controller use
Usability: Using a 5-point Likert scale (0- very difficult to 5- very easy; higher is better outcome), participants will be surveyed after the intervention period to assess ease of hand controller use.
Measured: up to 6 months
Usability as measured by patient-reported wearability of headset
Usability: Using a 5-point Likert scale (0- very difficult to 5- very easy; higher is better outcome), participants will be surveyed after the intervention period to assess wearability of headset.
Measured: up to 6 months
Usability as measured by patient-reported comfort of headset
Usability: Using a 5-point Likert scale (0- very difficult to 5- very easy; higher is better outcome), participants will be surveyed after the intervention period to assess comfort of headset.
Measured: up to 6 months
Number of participants who find the intervention acceptable
Acceptability: Participants will be asked if they would recommend this game to a friend or loved one, yes or no.
Measured: up to 6 months
Change in mobility activity frequency
To determine if a VR intervention increases mobility for patients on prolonged bedrest, the frequency of VR sessions is recorded. Frequency will be reported as counts.
Measured: Baseline, 6 months
Change in mobility activity time
To determine if a VR intervention increases mobility for patients on prolonged bedrest, the duration of each VR session is recorded. Activity will be reported as total minutes.
Measured: Baseline, 6 months
Change in Hospital Anxiety and Depression Scale (HADS) - anxiety
The Hospital Anxiety and Depression Scale (HADS) is a self-report scale used to measure the severity of depression and anxiety in patients with comorbid medical conditions. The total score for anxiety ranges from 0 to 21, where a higher score indicates greater anxiety.
Measured: Baseline to day 10 or ICU transfer, whichever comes first
Change in Hospital Anxiety and Depression Scale (HADS) - depression
The Hospital Anxiety and Depression Scale (HADS) is a self-report scale used to measure the severity of depression and anxiety in patients with comorbid medical conditions. The total score for depression ranges from 0 to 21, where a lower score indicates greater depression.
Measured: Baseline to day 10 or ICU transfer, whichever comes first
Change in UCLA 3-item Loneliness Scale
This scale comprises 3 questions that measure three dimensions of loneliness: relational connectedness, social connectedness and self-perceived isolation. The total score ranges from 0 to 9, where a higher score indicates greater loneliness.
Measured: Baseline to day 10 or ICU transfer, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start4 Dec 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MobilityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna E Mall, MSN, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797895
- Sponsor's protocol ID
- PRO00116448
- Acronym
- GAMERS
- Status last verified
- Feb 2026
- First submitted
- 9 Dec 2024
- Last updated
- 18 Feb 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 18 Feb 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
- NCT06797895
- Acronym / sponsor ID
- GAMERS / PRO00116448
- Conditions
- Mobility, ICU, Heart Surgery, Nursing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 29 Jan 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 goal of this study is to explore if Virtual Reality helps patients in the cardiothoracic ICU move more and feel better. Participants will be asked to answer a survey about anxiety, depression, and loneliness. The study team will teach participants how to use the VR device and how to play the game. Participants will play the game at least once per day, but can play as much as they want. Study activities include nurse facilitated patient use of VR applications that involve upper body movement (e.g., using arms and hands to dance or hit objects in a virtual reality environment).
Detailed description
Patients who survive critical illness and prolonged intensive care unit (ICU) stays are at risk for debilitating physical (deconditioning, skin injury, and infection), and mental health impairment (depression, anxiety and PTSD). Early mobility improves these deleterious outcomes but is challenging to implement in patients on prolonged bedrest. The purpose of this study is to compare a nurse-led implementation of a Virtual Reality (VR) experience in the Cardio-Thoracic Intensive Care Unit (CT-ICU) to standard of care to improve mobility for patients on prolonged bedrest. The investigators hypothesize that nurse-led implementation of VR experiences in the CT-ICU, in combination with engineering-led patient-centered customization of the VR applications, will improve both the physical and psychological function of ICU patients on prolonged bedrest.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) intervention | Other | Behavioral: VR assisted mobilityCohort for observing the effects of the VR intervention on ICU mobility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult
- English speaking
- 3+ days ICU admission with limited mobility
Key exclusion criteria (5 listed)
- Pregnancy
- Blind/severe visual impairment
- History of seizures
- Intubation/sedation
- Special enteric contact isolation
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 |
|---|---|---|
| VR assisted mobilityCommercially-based VR experience used to help move upper extremities to music, similar to dancing or Tai-Chi. | Behavioural | Virtual Reality (VR) intervention |
Primary outcome
Feasibility as measured by nursing time required
Time frame: up to 6 months
For each participant, the total nursing time spent (in minutes) setting up and delivering the intervention will be recorded.
10 secondary outcomes
Usability as measured by patient-reported ease of playing the game
Time frame: up to 6 months
Usability as measured by patient-reported ease of hand controller use
Time frame: up to 6 months
Usability as measured by patient-reported wearability of headset
Time frame: up to 6 months
Usability as measured by patient-reported comfort of headset
Time frame: up to 6 months
Number of participants who find the intervention acceptable
Time frame: up to 6 months
Change in mobility activity frequency
Time frame: Baseline, 6 months
Change in mobility activity time
Time frame: Baseline, 6 months
Change in Hospital Anxiety and Depression Scale (HADS) - anxiety
Time frame: Baseline to day 10 or ICU transfer, whichever comes first
Change in Hospital Anxiety and Depression Scale (HADS) - depression
Time frame: Baseline to day 10 or ICU transfer, whichever comes first
Change in UCLA 3-item Loneliness Scale
Time frame: Baseline to day 10 or ICU transfer, whichever 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 18 Feb 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. This study is not recruiting at the moment.
Anna E Mall, MSN 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 VR assisted mobility in people with Mobility and 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 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?
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?
Feasibility as measured by nursing time required (time frame: up to 6 months). 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 18 Feb 2026.