A Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

Completed · Not applicable · Has a placebo group

Conditions studied: Neoplasm, Caregivers

In brief

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....

Key facts

Study ID: NCT05909202
Run by: National Institutes of Health Clinical Center (CC)
People needed: 28
Starts: 2024-06-05
Expected to finish: 2026-02-27
Last updated by the study team: 2026-04-20

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Caregiver subjects
An individual who meets any of the following criteria will be excluded from participation in this study:
Serving as a paid caregiver for the patient.
Not agreeing to follow the study procedures.
Recent use of immersive VR programs for stress relief and/or entertainment (more than 2 days/week within the past 3 months). *
Participation in another stress-reduction type interventional study within the past 3 months.
Having a medical condition that is prone to frequent nausea or dizziness.
Current or past history of seizure, chronic migraines, epilepsy, claustrophobia, panic disorder, post-traumatic stress disorder, generalized anxiety disorder, major depressive disorder or other known severe neurological or mental health disorders.
Being sensitive to flashing light or motion.
Having a balance disorder such as vertigo and cybersickness.
Having another medical condition or injury that may prevent use of VR headset and/or VR software (e.g., visual or hearing problems, open sores, wounds, skin rash on face, or active infection).
Self-reported diagnosis of Opioid, Cocaine and/or Cannabis use disorder in the past year.
In Phase II, if a participant from Sham VR group personally uses immersive VR programs for stress relief and/or entertainment (more than 2 days/week) during the study period, the participant will be no longer eligible.
HSCT recipient subjects:
Not agreeing to follow the study procedures.

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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