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

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Jun 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a nature-based virtual reality (VR) program can help reduce stress in family caregivers of patients who have received an allogeneic hematopoietic stem cell transplant (HSCT). Caregivers often experience high levels of stress, which can lead to feelings of anxiety, depression, and fatigue. The study aims to see if spending 20 minutes a day using a VR headset, which provides immersive videos and sounds of nature, can improve their well-being.

To participate, caregivers must be at least 18 years old and be the primary caregiver for an adult HSCT patient undergoing their first transplant at the NIH Clinical Center. Participants will be involved for four weeks, with two clinic visits and weekly surveys about their stress levels. They will also provide saliva and blood samples at the beginning and end of the study. This research could provide important insights into how to better support caregivers who play a crucial role in the recovery of HSCT patients.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Caregiver subjects
• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• • 1. Ability to understand and the willingness to sign a written informed consent document.
• • 2. Age 18 years and older.
• • 3. Serving as a primary caregiver\* for an adult patient (18 years and older) planning to undergo their 1st allogeneic HSCT at the NIH Clinical Center during the four-week study period.
• • 4. Ability to read, speak and understand English.
• • 5. Access to necessary resources for participating in online survey (i.e., computer, laptop, tablet, smartphone, internet access).
• • If more than one caregiver is planned for the transplant recipient during the transplant phase, only one primary caregiver will be eligible to participate in the study. A primary caregiver is defined as someone who lives with or provides care regularly for the HSCT recipient during the 4-week study period. Caregivers will be categorized as to whether they are the sole caregiver versus one of the multiple caregivers.
• • HSCT recipient subjects
• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• • 1. Ability to understand and the willingness to sign a written informed consent document.
• • 2. Age 18 years and older.
• • 3. Planning to undergo their 1st allogeneic HSCT at the NIH Clinical Center during the four-week study period.
• • 4. Ability to read, speak and understand English
• EXCLUSION CRITERIA:
• • Caregiver subjects
• An individual who meets any of the following criteria will be excluded from participation in this study:
• • 1. Serving as a paid caregiver for the patient.
• • 2. Not agreeing to follow the study procedures.
• • 3. Recent use of immersive VR programs for stress relief and/or entertainment (more than 2 days/week within the past 3 months). \*
• • 4. Participation in another stress-reduction type interventional study within the past 3 months.
• • 5. Having a medical condition that is prone to frequent nausea or dizziness.
• • 6. 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.
• • 7. Being sensitive to flashing light or motion.
• • 8. Having a balance disorder such as vertigo and cybersickness.
• • 9. 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).
• • 10. 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:
• • 1. Not agreeing to follow the study procedures.