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Effect of a non-drug intervention on pain and anxiety during influenza vaccination

Effect of a non-pharmacological intervention on pain and anxiety related to the administration of influenza vaccine in adults: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5zgy25w
Enrollment
Unknown
Registered
2021-12-09
Start date
2022-03-07
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccination

Interventions

350 Adults who will receive influenza vaccination will be allocated to the intervention group (n=175) and the control group (n=175). In the intervention group, 0,5ml the vaccine will be administered
E02.258

Sponsors

Departamento de Medicina e Enfermagem da Universidade Federal de Viçosa
Lead Sponsor
Departamento de Medicina e Enfermagem da Universidade Federal de Viçosa
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 years and over; both sexes; preserved cognition; be literate; receive only injection of the influenza vaccine via IM in the deltoid region

Exclusion criteria

Exclusion criteria: Participants reporting pain in the upper limbs; presence of injury or abrasions in the deltoid region; loss or alteration of sensation in the upper limbs, previous use of analgesics in the last six hours prior to immunization

Design outcomes

Primary

MeasureTime frame
Pain Levels. Numerical variable, measured before and after application of the vaccine. Before the vaccine, participants will be asked the expected level of pain, based on a numerical scale from 0 to 10 points. Immediately after the vaccine, the level of pain during the application of the vaccine will be asked, based on the same numerical scale from 0 to 10 points. To interpret the scale, the following levels will be considered: 0-1 without pain; 1-3 mild pain; 3-6 moderate pain; 6-9 severe pain; 9-10 very intense pain;Anxiety level. Numerical variable, measured before and after application of the vaccine, from the visual analogue scale of anxiety, in which they should mark their level of anxiety along a horizontal line with a scale of 0-10 (0 = no anxiety and 10 = greatest possible anxiety)

Secondary

MeasureTime frame
Satisfaction with the application of the vaccine = ordinal variable, measured on a 10-point Likert scale (0 = totally dissatisfied; 10 greatest satisfaction possible);Discomfort caused by the temperature of the frozen ice pack of the handheld device in contact with the skin, rated only by the IG participants, by a Likert scale (0 = “Not at all” to 10 = “Extremely uncomfortable”;Discomfort caused by vibration of the handheld device in contact with the skin, rated only by the IG participants, using a Likert scale (0 = “Not at all” to 10 = “Extremely uncomfortable”)

Countries

Brazil

Contacts

Public ContactElaine Lima
elaine.aparecida@ufv.br+55(31)997211404

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 11, 2026