Virtual Reality Intervention Alleviates Dyspnea in Patients Recovering From COVID Pneumonia
- Conditions
- DyspneaCovid19
- Interventions
- Device: COVVR_SynchDevice: COVVR_Asynch
- Registration Number
- NCT04844567
- Lead Sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Brief Summary
The present COVID-19 Virtual Reality (COVVR) clinical study is performed to test the hypothesis that an immersive virtual reality (iVR)-based Digital Therapeutics (DTx), would alleviate dyspnea by improving breathing comfort in patients recovering from COVID-19 pneumonia presenting with persistent dyspnea. We will further evaluate participants' perceived awareness of and agency over their breathing movements. Finally, we will track patients' perceived benefits related to the iVR intervention and the feasibility of using COVVR in the clinic or at home.
- Detailed Description
Persistent dyspnea is the experience of breathlessness that persists despite optimal treatment of the underlying pathophysiology, and results in physical, psychosocial disability for the patient. As observed for SARS-CoV and MERS-CoV patients, a significant portion of COVID-19 patients present with persistent respiratory physiological impairment and persistent breathlessness that may not be addressed with conventional respiratory treatment such as oxygen, bronchodilators, diuretics or non-invasive ventilation.
Previous research on respiration-related feedback in Virtual Reality (VR) has demonstrated strong and replicable effects of VR feedback over one's perceived sense of agency and control over one's virtually embodied respiration. Based on these studies, the VR intervention evaluated here aims to alleviate symptoms of perceived breathlessness.
This within-subject study will compare breathing comfort as well as breathing discomfort, prior, during, and after a VR intervention that provides embodied visual feedback of participants' on-going respiration. Primary outcomes include subjective reports from participants (breathing comfort and breathing discomfort) and the intervention's clinical feasibility. Secondary outcomes include subjective ratings on perceived embodiment and sense of agency, as well as changes in respiration rate and variability.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Recovering from COVID-19 pneumonia confirmed by RT-PCR for SARS-CoV-2
- Presented with persistent dyspnea with a self-rated intensity of five or higher (out of ten) on a visual analog dyspnea scale. ( "Do you have difficulty breathing?" "On a scale of 0 to 10, with 0 being no difficulty to breathe and 10 being the worst difficulty to breathe that you can imagine, where do you rank?".) This dyspnea rating will only used as an inclusion criterion and not as an outcome.
- Being able to give consent
- Being able to understand and speak French or English
- Any unstable respiratory, neurological, and cardiac conditions
- Any psychiatric illness
- Montreal Cognitive Assessment (MoCA) score below 25.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description COVVR_A COVVR_Asynch Participants in the COVVR_A arm complete the synchronous block first, followed by the asynchronous block. COVVR_A COVVR_Synch Participants in the COVVR_A arm complete the synchronous block first, followed by the asynchronous block. COVVR_B COVVR_Synch Participants in the COVVR_B arm complete the asynchronous block first, followed by the synchronous block. COVVR_B COVVR_Asynch Participants in the COVVR_B arm complete the asynchronous block first, followed by the synchronous block.
- Primary Outcome Measures
Name Time Method Efficacy (Breathing Comfort & Discomfort) through study completion, an average of one year Efficacy will be evaluated based on subjective feedback by the patients regarding their breathing comfort and discomfort, depending on the intervention.
Subjective ratings will be measured using a 7-point Likert scale with -3 = Strongly disagree, -2 = Disagree; -1 = Somewhat disagree; 0 = Neither agree nor disagree; 1 = Somewhat agree; 2 = Agree; 3= Strongly agree.
Comfort item: "My breathing was enjoyable" Discomfort item: "I had difficulty breathing"VR Intervention Feasibility through study completion, an average of one year Feasibility will be evaluated using a feedback questionnaire, alongside open feedback. Agreement with the questionnaire items indicates better feasibility, acceptance, and perceived outcome.
Ratings will be measured using a 7-point Likert scale with -3 = Strongly disagree, -2 = Disagree; -1 = Somewhat disagree; 0 = Neither agree nor disagree; 1 = Somewhat agree; 2 = Agree; 3= Strongly agree.
Satisfaction: Did you enjoy the VR experience? Rehabilitation: Would you like to continue using the device during your recovery? Hospital Use: Would you have liked to use this earlier during your stay at the hospital? Home Use: Would you like to continue using the device at home? Respiratory benefit: Do you think the VR feedback improved your breathing? Well-being benefit: Did the VR feedback make you feel better?
- Secondary Outcome Measures
Name Time Method Embodiment through study completion, an average of one year Change in subjective ratings about embodiment depending on VR intervention. Two control items are included that are not expected to change between conditions.
Ratings will be measured using a 7-point Likert scale with -3 = Strongly disagree, -2 = Disagree; -1 = Somewhat disagree; 0 = Neither agree nor disagree; 1 = Somewhat agree; 2 = Agree; 3= Strongly agree.
Breathing awareness: It seemed as if the flashing was my respiration Control 1: It seemed as if I had three bodies Breathing agency: I felt as if the virtual body was breathing with me Control 2: I felt as if the virtual body was drifting with the flashingRespiratory Rate Variability through study completion, an average of one year Change in respiratory rate variability depending on VR intervention. Respiratory rate variability (RRV) will be measured using inter-breath intervals (IBI).
RRV will be assessed with respect to baseline recordings.Respiratory Rate through study completion, an average of one year Change in respiratory rate depending on VR intervention. Respiratory rate (RR) will be measured in breaths per minute. RR will be assessed with respect to baseline recordings.
Trial Locations
- Locations (1)
Hopitaux Universitaires de Geneve (HUG)
🇨🇭Geneva, Switzerland