Table 6.
Health-related outcomes measured using the RE-AIM outcome of effectiveness with data collection time points
| RE-AIM outcome | Health-related outcomes | Dressing change time point | Source of data (measurement tool) | Assessor | Dressing change | |||
|---|---|---|---|---|---|---|---|---|
| Pre | Mid | Post | ||||||
| Potential effectiveness | Acute procedural pain | Pain intensity | x | x retro | x | FPS-R (≤ 8 years) [51], I-INRS (≥ 8 years) [52], FLACCa [53] | Hypnotherapist | Each dressing change |
| Pain unpleasantness | UNRS (≥ 8 years) [52] | |||||||
| State anxiety | x | x retro | x | VAS [54] | ||||
| Itch | Intensity | x | Itch-NRS: self-report ≥ 8 years, proxy-report < 8 years [55] | From 3rd dressing change | ||||
| Frequency | Questions on itch episodes (per week, per day) [55] | |||||||
| Physiologic measures of pain and distress | Heart rate | x | x | x | Monitoring device | Each dressing change | ||
| Salivary α amylase (in children’s saliva samples) | x | x | ELISA kits (Stratech Scientific, Avalon NSW) | Independent observer | ||||
| Wound healing | Duration and the total number of dressing changes until 95% re-epithelialisation | x | x | x | Medical records or reports of clinicians | Independent surgeon and nurse | ||
| % of re-epithelialisation | x | |||||||
NRS Numeric Rating Scale, INRS Numeric Rating Scale for Pain Intensity, UNRS Numeric Rating Scale for Pain Unpleasantness, FPS-R Faces Pain Scale-Revised, FLACC Face, Legs, Activity, Cry, Consolability, retro Retrospectively
aThe FLACC scale will be used as a behavioural measure of child participants’ pain using nurse observation