Heart rate monitoring to detect acute pain in non-verbal patients: a study protocol for a randomized controlled clinical trial

Table 1 Timeline of trial illustrating the timing of different biomarkers and data collection, as well as their corresponding hypothesis

Timepoint	T0		T1		T2
Nr. Week	1	2	3	4	5	6
Early group	Pre-intervention phase^a		Change in care procedure
Delayed group	Pre-intervention phase^a				Change in care procedure
Time of samples collected and corresponding hypothesis
Primary hypothesis	HR↑ + context	HR↑ + context	HR↑ + context	HR↑ + context	HR↑ + context	HR↑ + context
1^st Secondary	HR↑	HR↑	HR↑	HR↑	HR↑	HR↑
	Cytokines			Cytokines		Cytokines
	HRV			HRV		HRV
2^nd Secondary	CU^b					CU^b

^aRegistration of HR increases in potentially painful situations in the patient’s everyday life
^bCaregivers’ rated understanding of the patient as measured by a trial-specific survey, given in Table 4
Abbreviations: TG Treatment group, DG Delayed intervention group; HR↑ = Heart rate increases; Context = Contextual data; Cytokines = MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17; HRV = heart rate variability; metabolites; CU = ^bCaregiver’s rated understanding

ISSN: 1471-244X