An interventional study of Sham VR and Active VR in Neoplasm and Caregivers, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by National Institutes of Health Clinical Center (CC) · Not applicable, Interventional, and Supportive care
Background:
People who receive an allogeneic hematopoietic stem cell transplant (HSCT) require long-term care at home afterwards. Their caregivers often experience high levels of stress, which can lead to symptoms such as depression, anxiety, poor sleep, fatigue, and difficulties with concentration and memory.
Objective: To explore whether a nature-based immersive virtual reality (VR) program helps reduce stress in people who care for HSCT patients.
Eligibility:
People aged 18 and older who are primary caregivers of HSCT patients.
Design:
This is a two-phase study. Participants will be enrolled for 4 weeks. They will have 2 clinic visits.
Participants will have a physical exam at the beginning of the study. They will be asked to provide a saliva sample in Phase 1, and saliva and blood samples in Phase 2.
Participants will be given a VR headset. This is a device that looks like a pair of goggles worn over the eyes. They will be asked to wear the headset for 20 minutes per day. They will see 360 (Infinite) high-definition videos of nature and hear nature sounds.
Participants will record the time they spend using the VR headset in a daily diary. They will take surveys with questions about any stress and symptoms they feel once a week. This will take up to 5 minutes. Participants will have a short regular follow-up visit by phone one week after starting their participation.
At the end of the intervention study, participants will return for another physical exam. They will give saliva and/or blood samples again.
Researchers will also look at the medical records of the HSCT patients; the HSCT patients must consent to this....
Study Description:
This is an interventional protocol to decrease stress and symptoms with a four-week nature-based VR intervention in family caregivers of allogeneic HSCT recipients. This study is a two-phase study: Phase I will be a single-arm pre-post design focused on assessing the feasibility and acceptability of the four-week nature-based immersive VR program. Phase II will be a prospective randomized controlled group design to examine the effectiveness of the four-week nature-based immersive VR program (Active VR) on stress and symptoms compared to a four-week nature-based non-immersive VR program (Sham VR) in the target population.
Objectives:
Phase I
Primary Objective: To evaluate the feasibility and acceptability of the nature-based immersive VR program in HSCT caregivers.
Secondary Objectives: To examine the level of perceived restorativeness, perceived stress, and symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) in HSCT caregivers participating in the nature-based immersive VR program.
Exploratory Objectives: To examine relationships among variables including but not limited to perceived stress, symptoms, HSCT caregiver characteristics, HSCT recipient characteristics, and biomarkers.
Phase II
Primary Objective: To examine whether HSCT caregivers participating in Active VR demonstrate improved levels of perceived stress compared to those participating in Sham VR.
Secondary Objectives:
Exploratory Objectives: To examine relationships among variables including but not limited to perceived stress, symptoms, HSCT caregiver characteristics, HSCT recipient characteristics, and biomarkers.
Endpoints: Phase I
Primary Endpoints: Feasibility (recruitment, retention, and adherence rates) and acceptability (satisfaction, usability) measured at Time 4 (Day 28); acceptability (safety) from Time 0 (Baseline; Day 0) to Time 4
Secondary Endpoints: Perceived restorativeness measured at Time 4; changes in perceived stress from Time 0 to Time 4; changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) from Time 0 to Time 4
Phase II
Primary Endpoint: Changes in perceived stress from Time 0 to Time 4
Secondary Endpoints: Changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) from Time 0 to Time 4; acceptability (satisfaction, usability) measured at Time 4; acceptability (safety) from Time 0 to Time 4
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 28 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Caregiver subjects
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Access to necessary resources for participating in online survey (i.e., computer, laptop, tablet, smartphone, internet access).
HSCT recipient subjects
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
Caregiver subjects
An individual who meets any of the following criteria will be excluded from participation in this study:
Self-reported diagnosis of Opioid, Cocaine and/or Cannabis use disorder in the past year.
HSCT recipient subjects:
1. Not agreeing to follow the study procedures.
Nature-based immersive VR program, completion of questionnaires, and saliva and blood sample submission.
Device: Active VR
Nature-based non-immersive VR program, completion of questionnaires, and saliva and blood sample submission.
Device: Sham VR
Nature-based non-immersive VR program
Nature-based immersive VR program
Changes in perceived stress
The outcome will be used to assess the effects of the Active VR compared to the Sham VR.
Time frame: 4 weeks
Changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment), acceptability (satisfaction, usability), acceptability (safety) (Cross) (Cross) (Cross)
The outcome will be used to assess the effects of the Active VR compared to the Sham VR.
Time frame: 4 weeks
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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National Institutes of Health Clinical Center (CC)