Primary outcome variable | Measurement frequency |
---|---|
Nature and number of adverse events | Every 10 min during intervention, up to one hour post-intervention, one time next morning post-intervention |
Self-reported dizziness, discomfort and stress on a ten-point scale | Every 10 min up to one hour post-intervention, one time next morning post-intervention |
Number of serious or irreversible adverse events | Every 10 min, up to one hour post-intervention, one time next morning post-intervention |
Measured continuously for safety, recorded: | |
- Blood pressure systolic-diastolic | Baseline and every 5 min—> 30 min post-intervention |
- Heartrate | Baseline and every 5 min—> 30 min post-intervention |
- Respiratory rate | Baseline and every 5 min—> 30 min post-intervention |
- Oxygen saturation | Baseline and every 5 min—> 30 min post-intervention |
Feasibility questionnaire (total score and subscores) (in Supplementary Materials) | After 1st, 5th and 10th intervention |