Effect of vibration associated with cryotherapy on vaccine-related pain and anxiety levels in adults: study protocol for a randomized clinical trial

Table 1 Stages of study operationalization 2022

Steps	Study period
Steps	Enrolment	Allocation	Intervention	Post-intervention
Timepoint:	-T₁	T₀		T₁
Enrolment:
Identification of the Study Population - National Influenza Immunization Campaign	X
Eligibility Criteria	X
Informed Consent	X
Randomisation
Allocation of participants		X
Interventions
Control Group			X
Intervention Group			X
Assessment
Sociodemographic Data Collection	X
Expected level of pain with the vaccine	X
Self-reported anxiety level before the vaccine	X
Level of self-reported pain after vaccination	X			X
Self-reported anxiety level after the vaccine				X
Satisfaction with vaccine administration				X
Discomfort caused by the temperature of the frozen bag in contact with the skin				X
Discomfort caused by the vibration of the device in contact with the skin				X

ISSN: 1745-6215