Administrative information
Title {1} | A Virtual Reality Home-Based Training for the Management of Stress and Anxiety Among Healthcare Workers During the COVID-19 Pandemic: Study Protocol for a Randomized Controlled Trial |
Trial registration {2a and 2b}. | NCT04611399 (ClinicalTrials.gov) |
Protocol version {3} | 05/03/22 Version 3.0 |
Funding {4} | The authors received no specific funding for this work. |
Author details {5a} | Federica Pallavicini1*, Eleonora Orena2, Simona di Santo3, 4, Luca Greci5, Chiara Caragnano6, Paolo Ranieri7, Costanza Vuolato2, Alessandro Pepe1, Guido Veronese1, Stefano Stefanini8, Federica Achille8, Antonios Dakanalis9, Luca Bernardelli10, Francesca Sforza10, Angelo Rossini3, Carlo Caltagirone3, Sara Fascendini8, Massimo Clerici9, Giuseppe Riva11,12, Fabrizia Mantovani1 1 University of Milano Bicocca, Department of Human Sciences for Education “Riccardo Massa”, Milan (Italy) 2 Foundation IRCCS Neurological Institute Carlo Besta, Milan (Italy) 3 IRCCS Fondazione Santa Lucia, Roma (Italy) 4 Università degli Studi di Roma Tor Vergata, Roma (Italy) 5 Institute of Intelligent Industrial Technologies and Systems for Advanced Manufacturing (STIIMA) National Research Council of Italy (CNR), Lecco (Italy) 6 University of Milano Bicocca, Department of Psychology, Milano (Italy) 7 University of Milano Bicocca, Specialization School in Psychology, Milan (Italy) 8 Fondazione Europea Ricerca Biomedica (FERB), Gazzaniga (Italy) 9 University of Milano Bicocca, Department of Medicine and Surgery, Monza (Italy) 10 Become-Hub, Milan (Italy) 11 Humane Technology Lab., Università Cattolica del Sacro Cuore, Milan (Italy) 12 Applied Technology for Neuro-Psychology Lab., Istituto Auxologico Italiano, Milan (Italy) |
Name and contact information for the trial sponsor {5b} | The authors received no specific funding for this work. |
Role of sponsor {5c} | The authors received no specific funding for this work. |
Introduction
Background and rationale
Typology | Definition | Examples |
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PC-based | Require a connection between an HMD and a computer with advanced computational and graphics capabilities | Oculus Rift S, HTC Vive |
Console-based | Need a connection between an HMD and a gaming console | PlayStation VR |
Mobile | Consist in the integration of VR on mobile devices thanks to specific HMDs | Low-cost HMDs compatible with mobile phones such as Google Cardboard |
Standalone (all-in-one) | They do not need other technologies to work | Oculus Quest 2, HTC Vive Focus, Pico Interactive Neo |
Objectives
Methods/design
Design and setting
Sample size
Recruitment
Eligibility criteria
Allocation
Randomization
Withdrawn criteria
Strategies for monitoring and improving intervention protocol adherence
Participant timeline
Study period | ||||||
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Enrolment | Baseline | Allocation | Intervention | Post-intervention | Follow-up | |
Timepoint (weeks) | − 1 | 0 | 0 | 0 | 1 | 5 |
Enrolment: | ||||||
Eligibility screen | X | |||||
Informed consent | X | |||||
Allocation | X | |||||
Interventions | ||||||
Experimental group | ↔ | |||||
Control group | ↔ | |||||
Assessments: | ||||||
Demographics | X | |||||
Use of technological solutions and VR | X | |||||
Level of exposure to COVID-19 | X | |||||
FCOR | X | |||||
Stress and anxiety management | X | |||||
PSS-10 | X | X | X | |||
STAI-Y2 | X | X | X | |||
DASS-21 | X | X | X | |||
Knowledge of stress and anxiety | X | X | X | |||
STAI-Y1 | X | |||||
VAS-A | X | |||||
SUS | X | |||||
SDM | X | |||||
NPS | X | |||||
Difficulties and adverse effects | X | |||||
Interview | X |
Protocol
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Experimental group
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Control group
Experimental group
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Intake session (session 1): after signing the informed consent and completing the baseline questionnaire accessible online (i.e., demographic, ad hoc questionnaire about the use of technological solutions and VR, ad hoc questionnaire on the level of exposure to COVID-19, FCOR, ad hoc questionnaire on stress and anxiety management, PSS-10, STAI-Y2, DASS-21, ad hoc questionnaire on knowledge of stress and anxiety), participants will receive from the research psychologist an explanation about the aims and methods of the home-based VR program. Participants will be asked for their involvement and availability during a week to allow in-home training. The psychologist will remind participants to perform the training three per week, with a distance of 2 days between one session and another. Then, individuals will receive information about the safety and hygiene procedures to prevent COVID-19 infection (see Table 3). The psychologist will give participants the Oculus Quest 2, a consumer-grade standalone VR system that consists of an HMD and two controllers. Individuals will wear the headset and receive a short 15-min training on using the VR system. In particular, they will try the tutorial content available on the Oculus Store. Furthermore, individuals will receive a link to complete the online questionnaires (i.e., STAI-Y1, VAS-A) before and after each session. They will be provided with a log book in which to record technical problems, safety issues, and the date and time they used VR during the intervention. Finally, the research psychologist will schedule the date of the post-training session.
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Training sessions (sessions 2, 3, and 4): they will consist of three home sessions of approximately 30 min each, conducted in a week with a distance of 2 days between one session and another. Participants will try for about 15 min one path of the virtual psychoeducational experience MIND-VR in each session (see Fig. 2). Subsequently, they will use for about 10 min the virtual relaxation content The Secret Garden. Individuals will be asked to complete online the VAS-A and the STAI-Y1 at the beginning and the end of each session.
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Post-training session (session 5): the research psychologist will meet participants for the post-intervention interview at the end of the training. On this occasion, participants will return the Oculus Quest 2, which will undergo specific procedures to avoid contamination by COVID-19. Participants will be asked to complete within 1 week after completion of the intervention the online questionnaires (i.e., PSS-10, STAI-Y2, DASS-21, ad hoc questionnaire on knowledge of stress and anxiety, SUS, SDM, NPS, ad hoc questionnaire on difficulties and adverse effects).
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Follow-up session (session 6): the PSS-10, STAI-Y2, DASS-21, and the ad hoc questionnaire on knowledge of stress and anxiety will be conducted after a 1-month follow-up.
Safety and hygiene protocol |
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Instruct the participant on the safety and hygiene procedure •Inform the participant on the importance of the safety and hygiene procedure •During the intake and post-training session, participants will be asked to follow specific precautions described below •Participants with cold-like symptoms will be asked not to go to the experiment and to notify the experimenter |
Follow the following precautions during the intake session •To ensure the safety procedures for the prevention of COVID-19 infection, the session will be conducted in a clean and well-ventilated room inside the hospital •Before entering the room, both the experimenter and the participants will have to wash their hands with an alcohol-based disinfectant (at least 70%) •Tell the user to keep at least 1.5 m from the experimenter •The participant will take the headset placed on a table placed about 3 m away from the experimenter and will be explained how to wear it independently and how to use it |
Disinfect the headset after the post-training session •As soon as the session is finished, the experimenter will use a detergent with at least 70% alcohol to decontaminate the headset •The cleanable, waterproof face part, keys areas of the headset (i.e., top and bottom, the headbands, buttons), and controllers will be disinfected and allowed to dry on a clean surface •At the end of the procedure, the experimenter will have to disinfect his/her hands again |
Control group
Virtual reality experiences
Virtual reality psychoeducational experience on stress and anxiety: MIND-VR
Relaxing virtual experience: The Secret Garden
Hardware
Outcomes
Primary outcome measure
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The Depression, Anxiety and Stress Scale-21 Items (DASS-21) [81]: is a set of three self-report scales designed to measure depression, anxiety, and stress symptoms. Each of the three scales contains seven items, divided into subscales with similar content. The scores for depression, anxiety, and stress are calculated by adding up the scores for the relevant items.
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Ad hoc questionnaire on the knowledge of stress and anxiety: individuals are asked to rate on a 7-point Likert scale (1 = “not at all,” 7 = “very much”) knowledge about the differences between anxiety and stress, causes and symptoms of stress and anxiety, and techniques for the management of these conditions. Besides, participants complete 5 factual questions in multiple-choice format (e.g., “Which is the first phase of the General Adaptation Syndrome?”) and 2 conceptual questions in short-answer format (e.g., “What are the three main categories of stress symptoms?”). The questions are based on the methodology used in a previous study (Parong and Mayer, 2018) (see Table 4).
Questionnaire on the knowledge of stress and anxiety |
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Part 1. Rate on a 7-point Likert scale (1 = “not at all,” 7 = “very much”) your level of knowledge about: • The differences between anxiety and stress • Causes and symptoms of stress and anxiety • Techniques for the management of stress and anxiety |
Part 2. Answer the following questions: • What is the first stage of the “general stress adaptation syndrome”? -Resistance phase -Exhaustion phase -Alarm phase -None of these • What is the main difference between stress and anxiety? -Symptoms and duration -Duration and causes -The causes and duration • Which of these is a symptom of social anxiety? -Constant and pervasive anxiety -Avoidance of social situations -Fear of enclosed spaces -None of the above • What is the main difference between acute stress disorder and post-traumatic stress disorder? -Duration -The causes -None of the above • Which of these biofeedback claims is incorrect? -Its primary purpose is to teach how to modify physiological response patterns -It consists of several sessions -Focuses on breathing -None of the above |
Part 3. Open-ended questions: • What are the three main categories of stress symptoms? • What are the main techniques for the management of stress and anxiety? |
Secondary outcome measure
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System Usability Score (SUS) [82]: it consists of 10 items on a 5-point Likert scale (1= “strongly agree,” 5= “strongly disagree”), relating to the possible critical issues encountered during the use of a VR system. A measure is provided on usability aspects (i.e., efficiency, clarity, reliability) and other aspects of the user experience (i.e., originality, stimulation).
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Subjective Difficulty Measure (SDM): it consists of a horizontal line 100 mm long, anchored by word descriptors at each end (from “not at all” to “very much”). Users mark on the line the perceived difficulty in using the VR system in general, MIND-VR, and The Secret Garden.
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Net Promoter Score (NPS) [83]: it evaluates user satisfaction with a product, in this case: the VR-home-based intervention in general, MIND-V, and The Secret Garden. It requires to indicate on a scale from 0 (“not at all”) to 100 (“very much”) how much they would recommend the products to a family member or friend.
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Ad hoc questionnaire on difficulties and adverse effects: individuals are asked to rate on a 7-point Likert scale (1=“not at all,” 7 = “very much”): If they had difficulty following the experimental protocol; if they had nausea, headache, dizziness, and eyestrain while using the VR system in general; if they had nausea, headache, dizziness, and eyestrain while using MIND-VR; if they had nausea, headache, dizziness, and eyestrain experienced while using The Secret Garden.
Other measures
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Demographic: genre, age, years of education, profession, hospital, work department, years of professional seniority
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Ad hoc questionnaire on the use of technological solutions and VR: individuals will be asked to indicate on a 7-point Likert scale (from “not at all” to “very”): the level of use in general of technological devices, the general level of acceptance of the technology, the level of knowledge of VR, and the level of experience with VR systems.
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Ad hoc questionnaire on the level of exposure to COVID-19: individuals are asked to answer the following questions (“yes”/“no”): Have you ever been caring for COVID-19 patients? Have you ever had family members or friends who became ill with COVID-19? Have you ever had family members or friends who passed away due to COVID-19? Have you ever had any laboratory tests (e.g., serological test, swab) for COVID-19? If you answered “Yes” to the previous question, how many times have you had a laboratory test for COVID-19? Have you ever tested positive for COVID-19? If you answered “Yes,” please indicate how many weeks you have been affected by COVID-19 and the level of severity of symptoms (from 1 “very mild” to 7 “very severe”).
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Fear Of Coronavirus (FCOR) [84]: it consists of a series of statements to measure the level of fear toward the COVID-19 pandemic. The questionnaire is composed of eight items that explore different components of fear, such as the personal experience of concern regarding the current situation, avoidance behaviors, and attention bias. Each statement is evaluated on a 5-point Likert scale.
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Ad hoc questionnaire on stress and anxiety management: 10-item scale developed to assess the use of stress and anxiety management programs and their perceived usefulness (see Table 5).Table 5The ad hoc questionnaire on stress and anxiety managementQuestionnaire on stress and anxiety managementPart 1. Please indicate if (“yes”/ “no”):• Have you ever followed psychotherapy?• Have you ever followed stress and anxiety management programs?• Since the COVID-19 outbreak, have you ever used remote stress and anxiety management programs (telephone or video)?• Since the COVID-19 outbreak, have you ever used face-to-face stress and anxiety management programs (single or group sessions)?Part 2. Rate on a 7-point Likert scale (1 = “not at all,” 7 = “very much”):• How important in general do you think to have psychological support for stress management and anxiety concerning your profession?• How important do you think it is to have psychological support for managing stress and anxiety in times of emergency, such as those experienced during the COVID-19 crisis?• How important do you feel to follow a stress and anxiety management program at this time in your life?• Have you ever attended meetings about stress and anxiety?• Have you ever searched the Internet for information on stress and anxiety?• Have you ever read books on stress and anxiety?
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State-Trait Anxiety Inventory Form Y-1 (STAI-Y1) [79, 80]: STAY-Y1 addresses state anxiety, which could be defined as a temporary emotional condition characterized by apprehension, tension, and fear about a particular situation or activity. This inventory consists of 20 items on a 4–4-point Likert scale, like the STAI-Y2.
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Visual Analogue Scale for Anxiety (VAS-A) [85, 86] is an instrument that measures state anxiety across a continuum. It is a horizontal line, 100 mm in length, anchored by word descriptors at each end (“no anxiety”; “very severe anxiety”). Individuals mark on the line the point that they feel represents their perception of their current state. The VAS-A score is determined by measuring in mm from the left-hand end of the line to the point that the person marks.