A Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

NCT05909202 | Completed

• 2 other identifiers: 10001636001636-CC
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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....

Conditions

Neoplasm; Caregivers

Keywords

Hematopoietic Stem Cell Transplantation; Biobehavioral; Nature; Virtual Reality; Stress

Outcome Measures

Primary Outcomes (1)

• Changes in perceived stress

  The outcome will be used to assess the effects of the Active VR compared to the Sham VR.

  4 weeks

Secondary Outcomes (1)

• Changes in symptoms (fatigue, sleep disturbance, depression, anxiety, cognitive impairment), acceptability (satisfaction, usability), acceptability (safety) (Cross) (Cross) (Cross)

  4 weeks

Study Arms (2)

Active VR Group

EXPERIMENTAL

Nature-based immersive VR program, completion of questionnaires, and saliva and blood sample submission.

Device: Active VR

Sham VR Group

SHAM COMPARATOR

Nature-based non-immersive VR program, completion of questionnaires, and saliva and blood sample submission.

Device: Sham VR

Interventions

Sham VR DEVICE

Nature-based non-immersive VR program

Sham VR Group

Active VR DEVICE

Nature-based immersive VR program

Active VR Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregiver subjects
• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Ability to understand and the willingness to sign a written informed consent document.
• Age 18 years and older.
• 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.
• Ability 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 to understand and the willingness to sign a written informed consent document.
• Age 18 years and older.
• Planning to undergo their 1st allogeneic HSCT at the NIH Clinical Center during the four-week study period.
• Ability to read, speak and understand English

You may not qualify if:

• 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, 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.
• Being sensitive to flashing light or motion.
• Having a balance disorder such as vertigo and cybersickness.
• 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).
• 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:
• \. Not agreeing to follow the study procedures.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Lee LJ, Son EH, Farmer N, Gerrard C, Tuason RT, Yang L, Kohn-Godbout J, Stephens C, Nahm ES, Smith L, Risch S, Wallen GR. Nature-based virtual reality intervention to manage stress in family caregivers of allogeneic hematopoietic stem cell transplant recipients: a two-phase pilot study protocol. Front Psychiatry. 2024 Mar 7;15:1295097. doi: 10.3389/fpsyt.2024.1295097. eCollection 2024.

  PMID: 38516258 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasms

Study Officials

• Lena J Lee, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 18, 2023
• Study Start: June 5, 2024
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)