Pain, Vaccination Adverse Event
Conditions
Brief summary
The aim of this study was to assess the acceptability and usability of a newly developed intradermal device in healthy adults
Interventions
DEVICEIntradermal injection in the forearm (0,1cc NaCl 0,9%)
This injection is conducted by the newly developed device.
DEVICEIntradermal injection in the upper arm (0,1cc NaCl 0,9%)
This injection is conducted by the newly developed device in the upper arm (deltoid region).
DRUGIntramuscular injection in the upper arm (0,5cc NaCl 0,9%)
This injection is conducted by needle and syringe in the upper arm (deltoid region).
Sponsors
Pierre Van Damme
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy adults
Exclusion criteria
* people who have regular experience with needle injections, e.g. diabetic patients * pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability (e.g. pain) of an injection with an intradermal vaccine delivery device compared to an intramuscular injection with syringe and needle | 1 day (directly after the injections) | Each of the volunteers was asked to complete two questionnaires: first questionnaire surveyed demographic parameters, including gender, age, health care related job or education, number of vaccinations and blood samples taken during the last 5 years, second questionnaire surveyed the experience of ID and/or IM injection, such as anxiety, pain during injection and duration of injection. Also the perception of the participant towards injections into the forearm, which could be perceived as an unnatural site for vaccination, and perception towards the need to undress for IM vaccination, i.e. preparing the upper arm for injection, was asked. The Visual Analogue Scale (1=no agreement; 10=full agreement) was used to score the statements. |
| Adverse events after an injection with an intradermal delivery device and/or intramuscular injection with syringe and needle | during 5 days after the injections | Volunteers were asked to fill a daily electronic diary for 5 days after the injections. The diary surveyed the presence of local reactions (pain at injection site, redness, swelling, ecchymosis and hardening) and systemic adverse events (headache, malaise, chills, myalgia, arthralgia, weakness/fatigue and temperature). In case of local reactions, participants were asked to measure the size of the reaction (in mm). For this purpose, a transparent ruler was provided to the participants at the study day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability (e.g. handling) of an injection with an intradermal vaccine delivery device compared to an intramuscular injection with syringe and needle | Within one day after administering the injections | At the end of a study day, the nurses performing the injections received a questionnaire that assessed the usability of VAX-ID. The nurses were requested to rate the attractiveness, handling, solidity, safety and ease of use. Some questions assessed their experience relating to painful(ness), speed and injection sites. Also their thoughts on the usability by non-medical staff (with or without any manual) and on self-administration by patients were inquired. The Visual Analogue Scale (1=no agreement; 10=full agreement) was used to score the statements. An expert panel was organized in order to gather additional comments, remarks and proposed improvements on the use of the VAX-ID. |
Countries
Belgium
Outcome results
None listed