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VR Intervention for Caregiver Stress
N/A
Waitlist Available
Led By Lena Jumin Lee (Park), Ph.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial tests if a nature-based immersive virtual reality helps reduce stress in caregivers of HSCT patients.
Who is the study for?
This trial is for adults over 18 who are the main caregivers for patients undergoing their first allogeneic HSCT at NIH Clinical Center. They must be able to understand English and have access to online survey tools. Only one primary caregiver per patient can join, and they should not be participating in other stress-reduction studies or have certain medical conditions.Check my eligibility
What is being tested?
The study tests if a nature-based VR program can reduce stress in caregivers of HSCT patients. Participants use a VR headset daily for four weeks, providing saliva and blood samples while also completing weekly surveys about their stress levels.See study design
What are the potential side effects?
There may be no direct side effects from the virtual reality experience itself; however, individuals prone to nausea, dizziness, seizures, or with balance disorders like vertigo might experience discomfort or adverse reactions when using the VR headset.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in perceived stress
Secondary outcome measures
Changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment), acceptability (satisfaction, usability), acceptability (safety) (Cross) (Cross) (Cross)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active VR GroupExperimental Treatment1 Intervention
Nature-based immersive VR program, completion of questionnaires, and saliva and blood sample submission.
Group II: Sham VR GroupPlacebo Group1 Intervention
Nature-based non-immersive VR program, completion of questionnaires, and saliva and blood sample submission.
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Who is running the clinical trial?
National Institutes of Health Clinical Center (CC)Lead Sponsor
383 Previous Clinical Trials
880,784 Total Patients Enrolled
1 Trials studying Tumors
49,946 Patients Enrolled for Tumors
Lena Jumin Lee (Park), Ph.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
2 Previous Clinical Trials
192 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I've used VR for stress relief or fun more than twice a week recently.I am a caregiver and have a history of severe neurological or mental health disorders.I am a caregiver and I suffer from balance issues like vertigo.I often feel nauseous or dizzy due to my medical condition.I plan to be the main caregiver for someone getting their first bone marrow transplant at NIH for 4 weeks.I agree to follow the study procedures if I receive a stem cell transplant.I am a caregiver and I am 18 years old or older.I can read, speak, and understand English.I will have my first bone marrow transplant from a donor at the NIH Clinical Center within 4 weeks.I can understand and am willing to sign the consent form.I can understand and am willing to sign the consent form.I am 18 or older and have received a stem cell transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Sham VR Group
- Group 2: Active VR Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 75 or younger eligible for this medical experiment?
"According to the stated requirements, individuals aged between 18 and 100 may be eligible for this trial. For younger patients (under 18) there are 320 studies available, while 2370 studies can cater to elderly people above 65 years of age."
Answered by AI
Is there presently an opportunity to join this medical experiment?
"The clinicaltrials.gov portal reveals that this medical investigation is no longer accepting participants. It was uploaded on June 22nd 2023 and the latest update was made on 16th of the same month. Despite not being able to enroll in this study, 2563 other studies are currently open for recruitment."
Answered by AI
Could I become a participant in this medical experiment?
"Patients that meet the criteria of being between 18 and 100 years old, with tumorous growths, can apply to be a part of this study. In total, 218 people are needed for its completion."
Answered by AI
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