Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT05909202
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05909202
Study Brief:
Protocol Section:
NCT05909202