Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Assessing the general and eye-related physical symptoms of exposure to a virtual reality environment. |
To assess these symptoms, the Virtual Reality Symptom Questionnaire (VRSQ) was used. The score assigned to each item ranges from 0 to 6, with a maximum total score of 84 (48 for general symptoms and 36 for eye symptoms). Higher scores represent worse symptoms, with 0 corresponding to no adverse effects, and 84 to serious adverse effects. |
Through study completion, an average of 6 months |
|
| Primary |
VR experience tolerability estimated based on the frequency of time spent in the VR context. |
The VR experience tolerability was estimated based on the frequency of time spent in the VR context. |
Through study completion, an average of 6 months |
|
| Primary |
Usability of the VR apparatus |
The usability has been investigated by a measure developed and described by Appel et al. (2020) composed of both self-reported questions and other queries that the experimenter answered by observing the participant's behavior during the experience and characterized by a series of items based on a 5 points Likert scale (Questions about Level of interest, awareness, engagement, and enjoyment observed: 1="very much", 5="not at all"; min. score=5 and max. score=25; higher scores mean a worse outcome. Questions on other information in relation to the VR experience: 1= "strongly disagree", 5= "strongly agree"; min. score=17 and max. score=85; higher scores mean a better outcome), and six open-ended questions focalized in obtaining additional information, where possible, about: 1) what participants liked best and least; 2) what participants would like to see; 3) if participants would like to repeat the experience; 4) if participants would recommend the experience to a friend. |
Through study completion, an average of 6 months |
|
| Secondary |
Change from before and after the one-shot VR session in the relaxation using the modified version of the State-Trait Anxiety Inventory-Y1 (STAI-Y1). |
The modified version of the State-Trait Anxiety Inventory-Y1 (STAI-Y1), inspired by Appel et al.16,17, was administered in this study to obtain information on the state-anxiety level experienced before and after the VR session.
The scale was administered as an interview based on a 5-point Likert scale from 1 (not at all) to 5 (a lot); min. score=15; max. score=75. Higher scores mean a worse outcome. |
Through study completion, an average of 6 months |
|
| Secondary |
Change from before and after the one-shot VR session in emotions felt using the Observed Emotion Rating Scale (OERS). |
The Observed Emotion Rating Scale (OERS) was adapted from the original version of Lawton et al.41 and used as an observation tool to assess the presence and frequency of negative emotions (fear, anxiety, anger, and sadness) and positive (pleasure) feelings experienced during the session based on a scale from 1 to 5 (1: "undetected emotion"; 2: "emotion observed for less than 16 seconds"; 3: "emotion observed for 16-59 seconds"; 4: "emotion observed for 1-5 minutes"; 5: "emotion observed for more than 5 minutes"). |
Through study completion, an average of 6 months |
|
| Secondary |
Feedback about the perceived quality rating of the VR set-up deployed from health care staff |
To obtain information from health professionals about the perceived quality rating of the VR set-up deployed, the Adapting-Mobile App Rating Scale (A-MARS)-Subjective Quality Scale was filled in by operators who participated during the VR sessions. The administration was performed at the end of the administration of the experimental procedure. (Likert scale from 1 to 5; min.score=4 and max.score=25; higher scores mean a better outcome). |
Through study completion, an average of 6 months |
|
| Secondary |
Feedback about usability from health care staff |
To obtain information from health professionals about usability of the VR set-up deployed, the System Usability Scale (SUS) was filled in by operators who participated during the VR sessions. The administration was performed after the administration of the experimental procedure. The SUS consists of a 10 item questionnaire on a 5-points Likert scale (1: Strongly agree; 5: Strongly disagree). The score for each question is converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Higher scores mean a better outcome. |
Through study completion, an average of 6 months |
|
| Secondary |
Feedback about acceptability from health care staff |
To obtain information from health professionals about acceptability, at the end of the experimental phase, a focus group was conducted with the health professionals that assisted users during the VR experience. Issues discussed during the focus group were the strengths and weaknesses associated with using virtual reality, the future perspectives, and the risks associated with using virtual reality with users affected by cognitive impairment. |
Through study completion, an average of 6 months |
|
