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

Geagea, Dali; Griffin, Bronwyn; Kimble, Roy; Polito, Vince; Terhune, Devin B.; Tyack, Zephanie

doi:10.1186/s40814-022-01017-z

Pilot and Feasibility Studies

Table 1 Evaluation frameworks guiding the process evaluation and data collection

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

Evaluation framework	Implementation outcome	Definition		Data collection
Evaluation framework	Implementation outcome	Definition		Source	Type
RE-AIM [30, 31]	Reach^a	Willingness of eligible families to participate in the study		Report on the rate of approached eligible families who consent to participate	Quantitative
	Effectiveness	Extent to which the intervention eliciting intended effects and the overall perceived benefits and potential undesired effects		Numeric ratings of pain, anxiety, and itch; physiologic measures of distress; data on wound re-epithelialisation	Quantitative
				Reported adverse events	Qualitative
				Reported perceived benefits	Qualitative
	Adoption by clinicians^b	Willingness of clinicians to take part in the study		Report on the rate of clinicians conducting dressing changes who consent to join the study	Quantitative
	Implementation	The quality of delivery and consistent delivery of study procedures as intended or prescribed in the protocol (i.e. fidelity)		Report on retention rates among children	Quantitative
				Level of adherence to the fidelity checklist in delivering the intervention	Quantitative
				Completeness of collected data on health outcomes	Quantitative
				Additional adaptations and modifications	Qualitative
	Maintenance	Degree of long-term outcomes by participants or program sustainability within the setting		Not assessed due to the absence of follow-up
TFA [27]	Acceptability	Perceived self-efficacy	Confidence in the ability to accomplish the behaviour(s) needed to participate in the intervention	Level of children’s perceived self-efficacy on a Likert scale	Quantitative
		Ethicality	Level of understanding of the intervention	Level of children’s positive therapy expectations on a Likert scale	Quantitative
		Coherence	Degree to which the intervention fits well with participants’ beliefs and value system	Semi-structured interview on beliefs and views of children and parents on hypnotherapy	Qualitative
		Perceived effectiveness	The degree to which the intervention is perceived as likely to succeed in its purpose	Families’ and clinicians’ satisfaction with hypnotherapeutic sessions and study procedures (procedures are not rated by clinicians) on NRS	Quantitative
		Perceived effectiveness		Semi-structured interview with parents, children, and clinicians on likes, dislikes, and recommendations	Qualitative
		Perceived burden	Perceived extent of effort required to engage in the intervention	Semi-structured interview on perceived required time and cognitive effort for the intervention	Qualitative
OIR [28]	Feasibility	The extent to which study procedures can be successfully delivered to participants in a distinctive context that is not fully controlled		- Number of disruptions - Available time (recordings)	Quantitative
OIR [28]	Feasibility			Field notes on the adequacy of resources	Qualitative

TFA Theoretical framework of acceptability, NRS Numeric Rating Scale, OIR Outcomes for implementation research
^aRepresentativeness (i.e. the similarity between participants and eligible patients) will not be assessed as part of Reach due to the small sample size [31]
^bAdoption at setting level is already established

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ISSN: 2055-5784

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