Nature-based virtual reality program for caregivers of stem cell transplant patients
A Pilot Study of a Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients
This study is testing if a nature-based virtual reality program can help reduce stress for caregivers of patients getting stem cell transplants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05909202 on ClinicalTrials.gov |
What this trial studies
This study explores the effectiveness of a nature-based immersive virtual reality (VR) program designed to reduce stress in primary caregivers of patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It consists of two phases: the first phase assesses the feasibility and acceptability of the VR intervention, while the second phase compares the effects of the immersive VR program to a non-immersive sham VR program. Participants will engage with the VR headset for 20 minutes daily over four weeks, with assessments of stress and related symptoms conducted throughout the study. The study aims to provide insights into the potential benefits of VR technology in supporting caregiver well-being.
Who should consider this trial
Good fit: Ideal candidates are primary caregivers aged 18 and older who are caring for adult patients undergoing their first allogeneic HSCT.
Not a fit: Patients who are not primary caregivers or those who do not have access to the necessary technology for participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce stress and improve the overall mental health of caregivers for HSCT patients.
How similar studies have performed: Other studies have shown promising results using VR interventions for stress reduction, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Lena Jumin Lee (Park), Ph.D. — National Institutes of Health Clinical Center (CC)
- Study coordinator: Chantal M Gerrard
- Email: chantal.gerrard@nih.gov
- Phone: (202) 839-7356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.