VR Intervention for Caregiver Stress

Overseen By Lena Jumin Lee (Park), Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Institutes of Health Clinical Center (CC)

Disqualifiers: Seizure, Epilepsy, PTSD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

218 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Nature-Based Virtual Reality (VR) Intervention for caregiver stress?

Research shows that nature-based VR experiences can help caregivers manage emotional symptoms like anxiety and depression by providing a calming and relaxing environment. A pilot study found that caregivers had positive experiences with the VR sessions, indicating high feasibility and acceptability of this treatment. ^{1 2 3 4 5}

Is Nature-Based Virtual Reality Intervention safe for humans?

Research shows that Nature-Based Virtual Reality (VR) experiences are generally safe for humans, with low reported symptoms during use. Participants in studies have mostly expressed positive experiences, indicating that this type of VR intervention is well-tolerated. ^{2 6 7 8 9}

How is the Nature-Based Virtual Reality Intervention treatment different from other treatments for caregiver stress?

This treatment is unique because it uses immersive virtual reality to simulate natural environments, which can help reduce stress by providing a sense of presence and relaxation, unlike traditional methods that may not offer such an engaging and restorative experience. ^{7 10 11 12 13}

Research Team

Lena Jumin Lee (Park), Ph.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Eligibility Criteria

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.

Inclusion Criteria

I plan to be the main caregiver for someone getting their first bone marrow transplant at NIH for 4 weeks.

Caregiver subjects must have access to necessary resources for participating in online survey (i.e., computer, laptop, tablet, smartphone, internet access)

I am a caregiver and I am 18 years old or older.

Exclusion Criteria

Caregiver subjects serving as a paid caregiver for the patient

Caregiver subjects not agreeing to follow the study procedures

I've used VR for stress relief or fun more than twice a week recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Phase I - Feasibility and Acceptability

Participants engage in a nature-based immersive VR program to assess feasibility and acceptability

4 weeks

1 visit (in-person), weekly follow-up (phone)

Phase II - Randomized Controlled Trial

Participants are randomized to either Active VR or Sham VR to assess effectiveness on stress and symptoms

4 weeks

1 visit (in-person), weekly follow-up (phone)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

1 week

1 follow-up visit (phone)

Treatment Details

Interventions

• Nature-Based Virtual Reality (VR) Intervention

Trial Overview 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.

Participant Groups

Group I: Active VR Group Experimental Treatment 1 Intervention

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

Group II: Sham VR Group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

National Institutes of Health Clinical Center (CC)

Lead Sponsor

Trials

391

Recruited

30,880,000+

Findings from Research

A virtual forest walk system using VR technology is designed to help cancer patients relax and improve their emotional well-being by immersing them in calming natural environments.

The study highlights the potential of VR to enhance the quality of life for cancer patients and the elderly, but emphasizes the need for further improvements in VR technology to ensure it is stress-free and enjoyable for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the psycho-oncological effectiveness of the bedside wellness system. Oyama, H., Ohsuga, M., Tatsuno, Y., et al.[2009]

A pilot study involving nine informal caregivers of cancer patients demonstrated that a 10-minute nature-based virtual reality (VR) experience was highly feasible and acceptable, with participants reporting low levels of VR-related symptoms.

Qualitative feedback from caregivers indicated positive perceptions of the VR experience, suggesting it could be a beneficial tool for managing emotional distress and improving quality of life for caregivers, especially in future studies involving those caring for patients at end of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nature-Based Virtual Reality Feasibility and Acceptability Pilot for Caregiver Respite. Alanazi, MO., Patano, A., Bente, G., et al.[2023]

Virtual Reality (VR) technology can enhance mental care for patients by providing interactive experiences that promote a sense of control and joy, potentially reducing pain and anxiety.

The 'Bedside Wellness System,' a developed VR system, has shown effectiveness in supporting patient well-being, suggesting that networked VR can facilitate communication and shared experiences among patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possibility of virtual reality for mental care. Ohsuga, M., Oyama, H.[2008]

A study involving 123 adults undergoing chemotherapy found that using virtual reality (VR) as a distraction made the treatment feel shorter and was generally well-received, with 82% of participants expressing a desire to use it again.

Despite the positive feedback on the VR experience, the intervention did not significantly reduce symptom distress immediately or two days after chemotherapy, indicating that while VR can enhance the treatment experience, it may not alleviate chemotherapy-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality: a distraction intervention for chemotherapy. Schneider, SM., Hood, LE.[2018]

The mobile game-based VR rehabilitation program (MoU-Rehab) significantly improved upper extremity function in stroke patients compared to conventional therapy, as measured by the Fugl-Meyer Assessment and other metrics.

The program was well-tolerated with no adverse effects reported, and patients expressed high satisfaction, indicating its feasibility as a rehabilitation tool for upper limb recovery after ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. Choi, YH., Ku, J., Lim, H., et al.[2019]

Virtual reality exposure (VRE) treatment for a Vietnam combat veteran with PTSD resulted in significant reductions in PTSD symptoms, with a 34% decrease in clinician-rated scores and a 45% decrease in self-rated scores.

The treatment effects were sustained over a 6-month follow-up period, suggesting that VRE could be a promising alternative to traditional exposure therapies for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy for PTSD Vietnam Veterans: a case study. Rothbaum, BO., Hodges, L., Alarcon, R., et al.[2015]

This study will evaluate a new virtual reality (VR) relaxation environment against a control group using self-chosen relaxation methods, involving 100 healthy participants to assess its effectiveness in reducing stress after a standardized stress induction.

The VR environment is designed to be immersive with multi-sensory features, potentially enhancing relaxation efficacy during acute stress situations without requiring prior training, which could lead to practical applications in stress management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating relaxation and stress reduction in healthy participants through a virtual reality intervention: study protocol for a non-inferiority randomized controlled trial. Kampa, M., Finke, J., Stalder, T., et al.[2022]

Immersive virtual reality (VR) environments can enhance the sense of presence compared to conventional photos, but this study found that exposure to forest environments positively impacted cognition, while urban environments negatively affected mood.

Interestingly, conventional photo slideshows of both urban and forest settings were more effective at reducing physiological arousal than immersive 360° videos, suggesting that simpler representations may sometimes be more beneficial for stress reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exposure to immersive videos and photo slideshows of forest and urban environments. Mostajeran, F., Krzikawski, J., Steinicke, F., et al.[2023]

In a study with 18 participants, viewing virtual reality (VR) natural scenes significantly reduced physiological stress markers (electrodermal activity) and negative mood compared to a control scene, indicating VR's potential for stress relief.

Participants showed a preference for certain natural scenes, which enhanced their relaxation and mood improvement, suggesting that personal preferences in scene selection can optimize the therapeutic effects of VR in isolated environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relaxation with Immersive Natural Scenes Presented Using Virtual Reality. Anderson, AP., Mayer, MD., Fellows, AM., et al.[2022]

A systematic review of 18 studies involving 848 participants found that virtual reality (VR) relaxation is a feasible and acceptable intervention that can effectively promote relaxation and reduce stress in adults with mental health conditions, particularly those experiencing anxiety and stress-related issues.

The studies utilized various nature-based virtual environments, demonstrating short-term effectiveness, and the methodological quality of most studies was rated as 'strong', indicating reliable evidence for the benefits of VR relaxation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality relaxation for people with mental health conditions: a systematic review. Riches, S., Jeyarajaguru, P., Taylor, L., et al.[2023]

In a study with 60 healthy employees, virtual reality (VR)-based heart rate variability biofeedback (HRV-BF) was found to be as effective as standard HRV-BF in improving cardiac coherence and vagal tone.

The VR-based HRV-BF significantly reduced perceived stress during a subsequent cognitive task, enhanced relaxation self-efficacy, decreased mind wandering, and improved focus, suggesting it may offer additional psychological benefits beyond standard methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart Rate Variability Biofeedback Based on Slow-Paced Breathing With Immersive Virtual Reality Nature Scenery. Blum, J., Rockstroh, C., Göritz, AS.[2023]

The STRIVE project is developing a Virtual Reality (VR) training program aimed at enhancing stress resilience in military personnel before deployment, building on positive initial outcomes from VR exposure therapy for PTSD.

This innovative approach includes immersive combat simulations and physiological monitoring to investigate stress responses, potentially providing effective coping strategies for emotional challenges faced in combat situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

STRIVE: Stress Resilience In Virtual Environments: a pre-deployment VR system for training emotional coping skills and assessing chronic and acute stress responses. Rizzo, A., Buckwalter, JG., John, B., et al.[2015]

A pilot study with 10 participants showed that a 360° video-based Virtual Reality (VR) intervention, consisting of five 13-minute sessions, can significantly reduce negative emotions and improve well-being during COVID-19 confinement.

Participants reported high levels of presence and perceived restorative qualities from the VR nature environments, indicating that this affordable technology can effectively mitigate the psychological stress associated with confinement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connecting to Nature through 360° Videos during COVID-19 Confinement: A Pilot Study of a Brief Psychological Intervention. Navarrete, J., Navarro-Siurana, J., Herrero, R., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

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Nature-Based Virtual Reality Feasibility and Acceptability Pilot for Caregiver Respite. [2023]

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Possibility of virtual reality for mental care. [2008]

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Virtual reality: a distraction intervention for chemotherapy. [2018]

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Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. [2019]

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Virtual reality exposure therapy for PTSD Vietnam Veterans: a case study. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Facilitating relaxation and stress reduction in healthy participants through a virtual reality intervention: study protocol for a non-inferiority randomized controlled trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effects of exposure to immersive videos and photo slideshows of forest and urban environments. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Relaxation with Immersive Natural Scenes Presented Using Virtual Reality. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Virtual reality relaxation for people with mental health conditions: a systematic review. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Heart Rate Variability Biofeedback Based on Slow-Paced Breathing With Immersive Virtual Reality Nature Scenery. [2023]

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STRIVE: Stress Resilience In Virtual Environments: a pre-deployment VR system for training emotional coping skills and assessing chronic and acute stress responses. [2015]

13. England pubmed.ncbi.nlm.nih.gov

Connecting to Nature through 360° Videos during COVID-19 Confinement: A Pilot Study of a Brief Psychological Intervention. [2022]