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

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
RE-AIM outcome	Health-related outcomes		Pre	Mid	Post	Source of data (measurement tool)	Assessor	Dressing change
Potential effectiveness	Acute procedural pain	Pain intensity	x	x retro	x	FPS-R (≤ 8 years) [51], I-INRS (≥ 8 years) [52], FLACC^a [53]	Hypnotherapist	Each dressing change
	Acute procedural pain	Pain unpleasantness	x	x retro	x	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
	Itch	Frequency			x	Questions on itch episodes (per week, per day) [55]		From 3rd dressing change
	Physiologic measures of pain and distress	Heart rate	x	x	x	Monitoring device		Each dressing change
	Physiologic measures of pain and distress	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
	Wound healing	% of re-epithelialisation		x		Medical records or reports of clinicians	Independent surgeon and nurse

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

ISSN: 2055-5784