- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05909202
A Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients
A Pilot Study of a Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients
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.
...
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Description:
This is an interventional protocol to decrease stress and symptoms with a four-week nature-based VR intervention in family caregivers of allogeneic HSCT recipients. This study is a two-phase study: Phase I will be a single arm pre-post design focused on assessing the feasibility and acceptability of the four-week nature-based immersive VR program. Phase II will be a prospective randomized controlled group design to examine the effectiveness of the four-week nature-based immersive VR program (Active VR) on stress and symptoms compared to a four-week nature-based non-immersive VR program (Sham VR) in the target population.
Objectives:
Phase I
Primary Objective: To evaluate the feasibility and acceptability of the nature-based immersive VR program in HSCT caregivers.
Secondary Objectives: To examine the level of perceived restorativeness, perceived stress, and symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) in HSCT caregivers participating in the nature-based immersive VR program.
Exploratory Objectives: To examine relationships among variables including but not limited to perceived stress, symptoms, HSCT caregiver characteristics, HSCT recipient characteristics, and biomarkers.
Phase II
Primary Objective: To examine whether HSCT caregivers participating in the Active VR demonstrate improved levels of perceived stress compared to those participating in the Sham VR.
Secondary Objectives:
- To examine whether HSCT caregivers participating in the Active VR demonstrate improved levels of symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) compared to those participating in the Sham VR.
- To examine the acceptability of the Active and Sham VR programs in HSCT caregivers.
Exploratory Objectives: To examine relationships among variables including but not limited to perceived stress, symptoms, HSCT caregiver characteristics, HSCT recipient characteristics, and biomarkers.
Endpoints: Phase I
Primary Endpoints: Feasibility (recruitment, retention, and adherence rates) and acceptability (satisfaction, usability) measured at Time 4 (Day 28); acceptability (safety) from Time 0 (Baseline; Day 0) to Time 4
Secondary Endpoints: Perceived restorativeness measured at Time 4; changes in perceived stress from Time 0 to Time 4; changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) from Time 0 to Time 4
Phase II
Primary Endpoint: Changes in perceived stress from Time 0 to Time 4
Secondary Endpoints: Changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment) from Time 0 to Time 4; acceptability (satisfaction, usability) measured at Time 4; acceptability (safety) from Time 0 to Time 4
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chantal M Gerrard
- Phone Number: (301) 594-5321
- Email: chantal.gerrard@nih.gov
Study Contact Backup
- Name: Lena Jumin Lee (Park), Ph.D.
- Phone Number: (301) 451-1266
- Email: jumin.park@nih.gov
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
-
Contact:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Phone Number: TTY dial 711 800-411-1222
- Email: ccopr@nih.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
- INCLUSION CRITERIA:
Caregiver subjects
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Age >= 18 years old
- 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
- Able to read, speak and understand English
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:
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Age >= 18 years old
- Undergo their first allogeneic HSCT at the NIH Clinical Center during the 4-week study period
- 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:
- 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, 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 balance disorder such as vertigo and cybersickness
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active VR Group
Nature-based immersive VR program, completion of questionnaires, and saliva and blood sample submission.
|
Nature-based immersive VR program
|
Sham Comparator: Sham VR Group
Nature-based non-immersive VR program, completion of questionnaires, and saliva and blood sample submission.
|
Nature-based non-immersive VR program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in perceived stress
Time Frame: 4 weeks
|
The outcome will be used to assess the effects of the Active VR compared to the Sham VR.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment), acceptability (satisfaction, usability), acceptability (safety) (Cross) (Cross) (Cross)
Time Frame: 4 weeks
|
The outcome will be used to assess the effects of the Active VR compared to the Sham VR.
|
4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lena Jumin Lee (Park), Ph.D., National Institutes of Health Clinical Center (CC)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 10001636
- 001636-CC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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