VR Intervention for Caregiver Stress

Overseen By Lena J Lee, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a nature-based virtual reality (VR) program can reduce stress for caregivers of patients who have received a stem cell transplant. These caregivers often experience high stress levels, which can lead to depression, anxiety, and poor sleep. Participants will use a VR headset daily to engage with calming nature scenes and sounds. Primary caregivers for stem cell transplant patients at home who haven't recently used VR for stress relief might be suitable candidates. The trial compares immersive VR experiences with non-immersive ones to identify which is more effective in reducing caregiver stress. As an unphased trial, it offers caregivers the opportunity to explore innovative stress relief methods in a supportive research environment.

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 prior data suggests that this VR intervention is safe for caregivers?

Research has shown that the nature-based virtual reality (VR) program is generally safe and easy to use. Studies have found that caregivers who tried this VR program experienced reduced stress. Evidence also indicates that these immersive experiences can help manage depression and anxiety without major side effects.

Most participants in earlier studies reported positive experiences, finding the VR sessions calming and refreshing. This suggests a safe way for caregivers to manage stress. While research continues, current data supports the safety of this VR treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nature-Based Virtual Reality (VR) Intervention for caregiver stress because it offers a new, immersive experience that standard treatments like therapy or medication do not provide. Unlike traditional methods, this VR intervention allows caregivers to virtually immerse themselves in calming, nature-based environments, potentially reducing stress in a way that's both innovative and engaging. The VR technology also provides a non-invasive, drug-free alternative, which can be appealing for those looking to avoid medication side effects. This fresh approach could provide a unique way to manage stress, offering immediate relaxation and relief in a controlled setting.

What evidence suggests that this VR intervention is effective for reducing caregiver stress?

Research has shown that virtual reality (VR) with nature scenes can help reduce stress. Studies have found that these VR experiences lower stress levels and improve mood for those who feel overwhelmed. In this trial, participants in the Active VR Group will experience a nature-based immersive VR program. Caregivers of patients undergoing certain medical treatments have reported that this program reduces stress. This suggests that watching calming nature scenes through VR can effectively manage stress. Overall, the evidence supports the idea that nature-based VR provides stress relief. ^{1 4 6 7 8}

Who Is on the Research Team?

Lena J Lee, Ph.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Are You a Good Fit for This Trial?

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

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

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

I can read, speak, and understand English.

Exclusion Criteria

Caregiver subjects not agreeing to follow the study procedures

Caregiver subjects serving as a paid caregiver for the patient

Caregiver subjects who participated in another stress-reduction type interventional study within the past 3 months

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

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2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11697538/

A nature-immersive virtual reality intervention to support ... Findings provide preliminary evidence for the efficacy of a nature-based VR intervention. Larger, diverse samples, with group randomization ...

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Nature-based virtual reality intervention to manage stress ... Nature-based virtual reality intervention to manage stress in family caregivers of allogeneic hematopoietic stem cell transplant recipients.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06732128

Nature-based Virtual Reality Intervention for Depression in ... The preliminary efficacy of N-VR in improving stress in individuals with AD-D using the Perceived Stress Scale (PSS) and data from the Fitbit ...

5. researchgate.net researchgate.net/publication/378797898_Nature-based_virtual_reality_intervention_to_manage_stress_in_family_caregivers_of_allogeneic_hematopoietic_stem_cell_transplant_recipients_a_two-phase_pilot_study_protocol

Nature-based virtual reality intervention to manage stress ... There is growing evidence that studies have reported the positive effects of the VR intervention in managing and reducing stress among diverse ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05909202

A Nature-Based Virtual Reality (VR) Intervention in Family ... Their caregivers often experience high levels of stress, which can lead to symptoms such as depression, anxiety, poor sleep, fatigue, and difficulties with ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2451865424000656

The Tandem VR™ protocol: Synchronized nature-based ... Our study uses the synchronized Tandem VR TM approach where patient-caregiver dyads experience immersive nature-based and other outdoor VR content.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10378650/

Nature-Based Virtual Reality Feasibility and Acceptability ... The aim of this mixed-method pilot was to evaluate the feasibility and acceptability of a nature-based VR experience for home-based CGs.