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NCT05909202 · ClinicalTrials.gov registry record · NA
A Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients
A NA study of Caregivers and Neoplasm, sponsored by National Institutes of Health Clinical Center (CC).
- Recruiting
- Registry status
- NA
- Development phase
- 218
- Enrollment target
- 1
- Study location
NCT05909202: Recruiting NA study of Caregivers and Neoplasm, sponsored by National Institutes of Health Clinical Center (CC).
NCT05909202 is a NA study of Caregivers and Neoplasm that is actively recruiting participants, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 218 participants, above the 86-participant average among 15 other Caregivers trials with a reported enrollment target (153% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05909202, a NA study of Caregivers and Neoplasm, is actively recruiting participants, sponsored by National Institutes of Health Clinical Center (CC).
- RECRUITING
- Registry status
- NA
- Development phase
- 218 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The outcome will be used to assess the effects of the Active VR compared to the Sham VR.
Conditions Studied
Interventions
- DEVICE Sham VR
- DEVICE Active VR
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2024-06-05 |
| Est. Completion | 2029-09-01 |
| Phase | NA |
What NCT05909202 shows while recruiting
NCT05909202 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, above the 86-participant average among 15 other Caregivers trials with a reported enrollment target (153% higher).
The record links to 2 conditions, with Caregivers appearing as the primary indexed condition, and to 2 interventions - of which Sham VR is the first listed.
NCT05909202 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05909202 about?
NCT05909202 is a clinical study titled "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...
What is the current status of trial NCT05909202?
This trial is currently recruiting. It is a NA study. The enrollment target is 218 participants. The study started on 2024-06-05. Estimated completion is 2029-09-01.
What conditions does trial NCT05909202 study?
This clinical trial studies the following conditions: Caregivers, Neoplasm.
What interventions are being tested in trial NCT05909202?
The interventions under investigation include: Sham VR (DEVICE), Active VR (DEVICE).
Who is sponsoring clinical trial NCT05909202?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05909202 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05909202's enrollment target sits among peer trials
218 3rd of 15 higher than 13 of 15 other Caregivers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Caregivers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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