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Table 6 Health-related outcomes measured using the RE-AIM outcome of effectiveness with data collection time points

From: Hypnotherapy for procedural pain, itch, and state anxiety in children with acute burns: a feasibility and acceptability study protocol

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  
  1. 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
  2. aThe FLACC scale will be used as a behavioural measure of child participants’ pain using nurse observation