This study is NOT currently recruiting participants.
Number
001636-CC
Sponsoring Institute
National Institutes of Health Clinical Center (CC)
Recruitment Detail
Type: Recruitment has not started Gender: Male & Female Min Age: 18 Years Max Age: 100 Years
Referral Letter Required
No
Population Exclusion(s)
Non-English Speaking;Children
Keywords
Hematopoietic Stem Cell Transplantation; Biobehavioral; Nature; Virtual Reality; Stress
Recruitment Keyword(s)
None
Condition(s)
Neoplasm; Caregivers
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Device: Sham VR Device: Active VR
Supporting Site
NIH Clinical Center
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.
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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 of subject to understand and the willingness to sign a written informed consent document. 2. Age >= 18 years old 3. Intend to serve as a primary caregiver* for a patient undergoing their 1st allogeneic HSCT at the NIH Clinical Center during the 4-week study period 4. Able 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 of subject to understand and the willingness to sign a written informed consent document. 2. Age >= 18 years old 3. Undergo their first allogeneic HSCT at the NIH Clinical Center during the 4-week study period 4. Able 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, 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 balance disorder such as vertigo and cybersickness 9. Having other medical condition or injury that may prevent use of HMD and/or VR software (e.g., visual or hearing problems, open sores, wounds, skin rash on face, or active infection) --In Phase II, if a participant from the 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
Caregiver subjects
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Ability of subject to understand and the willingness to sign a written informed consent document.
2. Age >= 18 years old
3. Intend to serve as a primary caregiver* for a patient undergoing their 1st allogeneic HSCT at the NIH Clinical Center during the 4-week study period
4. Able 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
3. Undergo their first allogeneic HSCT at the NIH Clinical Center during the 4-week study period
EXCLUSION CRITERIA:
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, 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 balance disorder such as vertigo and cybersickness
9. Having other medical condition or injury that may prevent use of HMD and/or VR software (e.g., visual or hearing problems, open sores, wounds, skin rash on face, or active infection)
--In Phase II, if a participant from the 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
Principal Investigator
Referral Contact
For more information: