Pivoting to “No Contact”: A Protocol for Conducting a Virtual Reality Relaxation Home Study for Teens Amidst the COVID-19 Pandemic

Abstract

Prior to the COVID-19 pandemic, our team planned to pilot a self-administered virtual reality environment for stress reduction. The purpose of this manuscript is to describe our pivot to a “no contact” protocol, including participant feedback and lessons learned. Our protocol included virtual reality study kit sanitization, delivery, and return; remote screening, consent, enrollment, and data collection; and virtual study visits. All study participants found the protocol to be acceptable. Lessons learned include strategies for institutional review board approval and improved orientation to the study technology. Despite a global pandemic, our “no contact” protocol was feasible and acceptable.

INTRODUCTION

Adolescents in the United States are experiencing unprecedented levels of stress compared with previous generations (American Psychological Association, 2018). Sources of adolescent stress include everyday stressors, such as academic pressures, interpersonal peer and family relationships, and extracurricular activities (Pew Research Center, 2019). National trends in threats to safety are other significant sources of adolescent stress, including assault, gun violence, racial discrimination, and the COVID-19 pandemic (American Psychological Association, 2018; Chen et al., 2020; Golberstein, Wen, & Miller, 2020; Pew Research Center, 2019). A known precursor to anxiety and depression, this generational rise in stress has even been described as creating a cohort effect of serious psychological distress (Twenge, Cooper, Joiner, Duffy, & Binau, 2019). The consequences of chronic stress extend beyond mental health to impaired daytime functioning, including learning, memory, and academic performance (McEwen, 2017; Vogel & Schwabe, 2016).

Adolescence is a period of tremendous physical and cognitive development, including the development of one’s stress reactivity or one’s response to stressors (Cotella et al., 2019; Romeo, 2013). The plasticity of the developing brain makes adolescents especially vulnerable to chronic stress, which may, in turn, cause an enduring dysregulation of stress reactivity (Roos, Levens, & Bennett, 2018). Despite practice guidelines on the management of adolescent anxiety and depression (Walter et al., 2020; Zuckerbrot et al., 2018), the incidence of anxiety and mood disorders continues to rise (Centers for Disease Control and Prevention, 2020a). Given the immediate and long-term consequences of adolescent stress, there is a critical need for stress management interventions (Chen et al., 2020; Golberstein et al., 2020). The ubiquity of adolescent stress also highlights the need for convenient, self-administered interventions with the potential to scale for broad adoption.

Virtual Reality (VR) consists of a headset that displays a three-dimensional simulated environment within which one may explore or interact. The use of the VR headset is relatively straightforward, which lends itself to self-administration. This ease of use coupled with the immersive experience of VR has led to a range of therapeutic applications. Among adults, VR has been shown to be effective in treating posttraumatic stress disorder (Deng et al., 2019), phobias (Donker et al., 2019), and perceived stress and affect in military personnel (Pallavicini, Argenton, Toniazzi, Aceti, & Mantovani, 2016). Applications in youth are more limited, although studies in children and adolescents have demonstrated efficacy for reduction of procedural and wound care pain and anxiety (Gold & Mahrer, 2018; Jeffs et al., 2014), suggesting that the benefits of VR may be applied to other adolescent populations.

The purpose of the present study was to pilot the use of home-based VR using a commercially available VR environment, Nature Treks VR, as a stress-reduction strategy. Although the use of VR for relaxation is not a novel application, we discovered a paucity of literature describing the implementation of a home-based VR pilot study, particularly among teens. Furthermore, our experience pivoting to a “no contact” study amidst the COVID-19 pandemic necessitated numerous protocol modifications. Given these experiences, the purpose of this manuscript is to describe the methodologic challenges we encountered and to outline successful strategies to implement a “no contact” VR pilot home study with teens.

NATURE TREKS VR

Nature Treks VR (Greener Games, Telford, UK) is a commercially available VR application consisting of a suite of color-themed natural environments. Available environments within Nature Treks VR include White Winter (a snowy landscape), Red Fall, Orange Sunset, Green Meadows, Blue Ocean, and Red Savanna. Unlike typical VR games, there is no objective, competition, or time-bound activity. Rather, Nature Treks VR aims to promote relaxation through an immersive experience of soothing audio while the user freely explores the natural environments where they encounter a variety of wildlife.

IN-PERSON PROTOCOL FOR VR HOME STUDY

The in-person protocol for the present study was adapted from our protocol for a recent VR home study for older teens. The protocol included two in-person visits; the first visit comprised consent, baseline surveys, and onboarding, whereas the second visit included postintervention surveys and an exit interview. During the initial visit, participants were provided the VR Study Kit for use at home, which consisted of an Oculus Go (Oculus, Menlo Park, CA) VR headset preloaded with Nature Treks VR, controller, charging cable, and spare batteries. Eligibility criteria included 18–19 years of age, a student at the University of Washington, and English speaking. Exclusion criteria included visual or hearing impairments, which preclude the use of VR; severe developmental delay and/or inability to consent; or a history of vertigo, epilepsy, or extreme motion sickness, which increase the likelihood of experiencing nausea while using VR. To maximize the likelihood that our participants experienced stress during the intervention period, the 2 weeks pilot study was scheduled during the final week of the academic spring quarter and final examinations week (mid to late June 2020).

The recruitment plan included posting flyers in University dormitories, on various social media channels, and on listservs and included snowball sampling. Those interested in participating contacted the principal investigator (E.B.) via phone or e-mail to determine eligibility; if eligible, participants were invited for a baseline study session on campus. The baseline visit consisted of informed consent followed by a series of electronic surveys. The demographics survey included age, race, ethnicity, year in school, gender identity, and prior experience with VR. Note, this small pilot study did not seek to measure the efficacy of the intervention, although we included validated measures for variables of interest before and after, including perceived stress, cognitive fusion, loneliness, anxiety, and depression. Following survey completion, a study team member oriented the participant to the use of the VR headset and how to access the VR environments. Participants were provided an onboarding manual that outlined step-by-step instructions on the use of the VR headset and environment and an instruments booklet containing stress and mood visual analog scales (VAS) and VR session logs. After this initial session, participants took the VR Study Kit home to use for the duration of the 2-week study.

Participants were asked to use the VR headset at least three times per week for approximately 5–15 min. Before use, they completed the pre-session paper stress and mood VAS. After using the headset, they completed the post-session VAS and session log. The post-session log asked participants to indicate the environment(s) visited, the session duration, and the animals encountered and to add any additional comments. The study team conducted a midway phone or videoconference check-in to discuss any concerns and troubleshoot if needed. After the study, participants attended the final in-person visit, during which time they returned the VR Study Kit materials, completed postintervention surveys, and participated in a brief exit interview. The exit interview sought feedback about Nature Treks, the use of VR at home, and feedback about the study protocol and procedures. The University of Washington Institutional Review Board (IRB) approved this study protocol (STUDY00003795).

ADAPTATION TO “NO CONTACT” PROTOCOL

The COVID-19 pandemic necessitated a swift pivot to a “no contact” protocol for our 2020 VR Home Study. Whereas we previously planned in-person sessions to deliver study kits and orient subjects to the use of the VR headset and Nature Treks VR environments, we swiftly developed a remote “no contact” protocol (Table). This protocol included VR Study Kit sanitization, delivery, and return; remote screening, consent, enrollment, and data collection; and virtual study visits.

TABLE.

Before COVID-19 and COVID-19 intervention protocols

Before COVID-19	COVID-19 protocol
Onboarding	Onboarding
Home study	Home study
Complete paper “Before Headset” stress and mood VAS Use VR for 5–15 min Complete paper “After Headset” stress and mood VAS Complete paper VR session log	Scan QR Code and complete REDCap stress and mood VAS Use VR for 5–15 min Complete REDCap VR stress and mood VAS Complete REDCap VR session log
Midpoint check-in	Midpoint check-in
Exit interview	Exit interview

Note. VAS, visual analog scales; QR, quick response; VR, virtual reality.

VR Study Kit

One of the most significant challenges to pivoting to a virtual intervention was related to the preparation, delivery, and return of the VR Study Kits. Given the concern for potential surface transmission of COVID-19, the University of Washington IRB required a detailed protocol to minimize the risk of transmission of COVID-19 to participants and the research team. This novel protocol addressed the preparation as well as delivery and return of the VR Study Kits.

Sanitization

To our knowledge, there is a lack of VR headset cleaning and sanitizing protocols available for study teams. The VR headset manufacturer guidelines provided insufficient guidance; therefore, we adapted the Centers for Disease Control and Prevention electronics protocol for cleaning (Box; Centers for Disease Control and Prevention, 2020b). All porous and nonporous surfaces were sanitized using wipes containing at least 70% alcohol; surfaces were wiped until dampened, including porous surfaces, and left to air dry. The VR Study Kits were then assembled and left in a 72-hr quarantine before delivery.

BOX. COVID-19 virtual reality study kit sanitation protocol.

Sanitize

1. Hand hygiene

2. Don mask and nitrile gloves

3. 70% Isopropyl alcohol lens cleaning wipes

   • Wipe lenses until dampened
4. 70% alcohol-based wipes

   • Wipe all other porous and nonporous surfaces until dampened
   • Includes headsets, controllers, charging cables, storage box

5. Allow equipment to air dry

6. Hand hygiene

7. 72-hr quarantine

Package for delivery after quarantine

1. Hand hygiene

2. Don mask and nitrile gloves

3. Package dry equipment into sanitized boxes

4. Place boxed virtual reality equipment in a delivery bag

5. Remove mask and dispose of gloves

6. Hand hygiene

Note. COVID-19, coronavirus disease 2019.

Delivery and return

Participants indicated availability during the study period, the final week of the University quarter, and the finals week, during eligibility screening. The study team scheduled VR Study Kit delivery appointments at the participant’s home before the study period. Text reminders for the delivery time were sent the night before, 30 min before, and when the study team member arrived. On arrival, subjects were advised of the “no contact” handoff whereby they were to maintain physical distancing. The study team member, wearing a mask and gloves, would drop the study kit on the participant’s doorstep and confirm receipt of the kit.

The study team used a similar process for participants to return the study kits. Appointments were arranged and confirmed via text message. On arrival, the study team member would text the participant, who would drop the kit on their doorstep. The study team member, wearing a mask and gloves, would receive the kit while maintaining physical distancing. The kits were left in quarantine for 72 hr, and then each kit was sanitized using the protocol described in Box.

REMOTE DATA COLLECTION VIA REDCAP

Screening and Enrollment

REDCap, a secure web-based data capture and management system, was used for participant screening, consent, and data collection (Harris et al., 2009). Although we retained our original recruitment strategies, such as posting on social media channels and listservs, we adopted an entirely remote screening, consent, and data collection strategy. All recruitment materials contained a web link and quick response (QR) code to the REDCap study eligibility screening; interested participants were asked to complete the eligibility screening, which automatically indicated whether they met the eligibility criteria. For those who met eligibility criteria, REDCap sent an automated e-mail to the participant describing the study activities, compensation, and timeline. Those interested in joining the study were instructed to click the embedded consent web link. The REDCap auto-archiver + e-Consent framework was enabled, whereby the participants completed consent procedures online and were provided the option to download and save a portable document format (PDF) copy of their signed consent. REDCap was configured such that the study team was notified by e-mail whenever a participant completed the consent form, ensuring timely monitoring of participant enrollment and progress.

Study Surveys

On completion of the study consent, the baseline study survey queue was automatically generated. The users independently completed a series of baseline surveys to measure demographics and other study variables (perceived stress, cognitive fusion, loneliness, anxiety, and depression). The study team used the REDCap record status dashboard to ensure that baseline surveys were completed before scheduling delivery of the VR Study Kit. The study team sent REDCap e-mail reminders to participants who had incomplete surveys. Postintervention surveys were nearly identical, excluding demographics, and sent automatically by REDCap at the end of the study via a web link.

Pre- and Post-VR Session

As in our original protocol, participants were asked to use the VR headset at least three times per week for approximately 5–15 min. VR session logs were used to track VR headset use, mood and stress ratings before and after use, and information about the VR session. The study team prepared small “visors” that fit inside the VR headset that would serve as a visual reminder to complete the pre-session survey (Figure 1). The visor contained a printed QR code unique to the study subject; when the code was scanned using the participant’s smartphone, their individualized REDCap VR session survey would open. Pre-session items included mood and stress VAS scales (Figure 2). Next, participants were instructed to time-stamp their submission by clicking the “now” button, which recorded the date and time. The survey instructed participants to return to the survey after they completed their session. After session use, participants were prompted to click “now” again, complete post-session stress and mood VAS, and then indicate the environment(s) they visited, animals encountered, and to add any additional comments.

FIGURE 1. Visor with individualized quick response (QR) code to access REDCap virtual reality (VR) session surveys.

QR code is intentionally blurred.

FIGURE 2.

Stress and mood visual analog scales via REDCap. ID, identification document; QR, quick response

Stress and Mood Ecological Momentary Assessment

One of our primary limitations in the original protocol was our inability to collect ecological momentary assessment (EMA) of participant mood and stress (Stone & Shiffman, 1994). Given the variability of mood and stress levels throughout the day, EMA involved the repeated sampling of subject data in real-time to accurately capture stress and mood variability. By leveraging Twilio (Twilio Inc., San Francisco, CA), a third-party web service that offers a plugin for REDCap that enables automated short message service (SMS) or text messages. We configured REDCap to send the stress and mood VAS surveys to participants by SMS at specific times during the day (0900, 1400, and 1900), including a reminder SMS 1 hr later if they did not respond. The scales were sent via SMS text message throughout the 2-week intervention. This strategy ensured we would collect daily stress and mood scales in addition to the pre- and post-VR session ratings described earlier.

VIRTUAL STUDY VISITS

As an alternative to the planned in-person study visits, we arranged for videoconference visits at the beginning, midway, and end of the study via Zoom (Zoom Video Communications, Inc., San Jose, CA). We prearranged the Zoom meetings to automatically record and transcribe each session, which included the Zoom recording disclaimer advising the participant that the session would be recorded. Following the delivery of the VR Study Kits, one research team member met with every participant for a brief onboarding session. The participant was asked to unbox the VR headset, power on, and navigate the VR environment. The study team member reviewed the online instructions; study surveys, including daily EMA mood and stress scales; as well as accessing the pre- and post-session surveys via the QR code visor. The midway study visit functioned as check-in and provided participants with the opportunity to ask questions or troubleshoot the equipment as needed. In addition, participants were asked about their frequency of use and typical session duration. The exit interview examined participant feedback about Nature Treks, the use of VR at home, feedback about the study protocol and procedures, and recommendations for future improvements.

RESULTS

Twenty-one individuals completed the online eligibility screening. Seven were excluded because of being over 19 years of age. Eleven out of 14 eligible individuals enrolled in the study, and all completed the study and final data collection session. Participants were aged 18.8 ± 0.4 years, and six were male. Six participants identified as Asian, two were more than one race, two preferred not to identify their race, and one identified as White. Three participants described their ethnicity as Indian and two as Latino. Most of the teens reported past VR use of zero to one time (n = 7) only, one reported 2–5 times, and three reported > 6 times. Although the presentation of all study variables is beyond the scope of this manuscript, our high enrollment and retention rates indicate protocol acceptability among a mostly VR-naive sample. In addition, the exit interviews also indicated that all study participants found the study to be acceptable and would recommend it to a friend in the future. “I don’t have any stress from [the protocol]. I think it was perfect.” – Female, 18.

LESSONS LEARNED

Although study participants indicated overall acceptability of our protocol, there are several lessons learned that warrant discussion, including IRB approval, confusion over “no contact,” and improved orientation to the study technology. Securing IRB approval of the “no contact” protocol was especially onerous, in large part because of the uncertainty regarding COVID-19 transmission and relatively sparse literature on VR equipment cleaning guidance. Given the absence of published studies conducting VR sanitation, the adaptation of the Centers for Disease Control and Prevention guidelines for electronics sanitization was sufficient to secure IRB approval. We anticipate publication of this protocol will provide additional evidence-based guidance for similar studies in the future. Although most of our participants understood our use of “no contact” terminology, we did have one who mistook this to mean no contact of any kind, including via text or e-mail. Our lesson learned is to be explicit that “no contact” refers to any direct person-to-person contact during study visits or delivery of study materials. Finally, despite our virtual study visits, a participant recommended an orientation video demonstrating the use of the VR headset and study surveys. “It would be helpful to have a video of a researcher just telling people from like start to finish from receiving the box, what it involves, what are the different stuff, what you can and can’t do.” – Male, 19. Such a video would provide an accessible reference throughout the study. We also learned that a minor modification of the REDCap surveys would be desired—”If I could change anything, it would just be somehow to make the daily surveys easier. The reminder is nice but I wish there was some way to know that it was definitely complete” – Female, 19. This concern is easily addressed by having a submission confirmation page when participants complete a survey.

Conclusions

Despite an unprecedented global pandemic, our pivot to a “no contact” protocol enabled us to proceed with our VR home study. Study participants indicated acceptability of our protocol and were especially excited to pilot an innovative stress-reduction intervention amidst a universally stressful time. An unanticipated benefit of our “no contact” protocol was an overall reduction of both participant and study team burden by leveraging existing tools such as REDCap, Twilio, and Zoom. Although the COVID-19 pandemic has brought forth unparalleled challenges for research teams, we acknowledge that it also served as a catalyst for innovation. We anticipate applying a modified version of this protocol to a larger-scale study evaluating the efficacy of a home-based VR stress-reduction intervention for teens. Such an intervention holds tremendous promise in preventing the serious and often lifelong consequences of chronic stress in adolescence.