Reduction of Pain in Childhood Vaccination in the Primary Care Nurse Vaccination Consultation (NCT06004258) | Clinical Trial Compass
CompletedNot Applicable
Reduction of Pain in Childhood Vaccination in the Primary Care Nurse Vaccination Consultation
Spain495 participantsStarted 2022-06-21
Plain-language summary
Non-randomized study with control group (CG) with the objective of analyzing the non-pharmacological analgesic efficacy of the "Painless Vaccine" protocol for the reduction of pain during vaccination in the population aged 2 months to 14 years participating in the experimental group (EG) versus traditional vaccination (CG).
Who can participate
Age range
2 Months – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Niñas/os de 2 meses a 14 años que acuden a las consultas del Programa de Vacunación infantil de Andalucía.
* Que al menos uno de sus padres/tutores haya firmado el consentimiento informado por representación del menor para participar en este estudio.
* Sin límite por población residencia.
* Que pertenezcan a las poblaciones de estudio (intervención y control).
Exclusion Criteria:
* No se han contemplado criterios de exclusión. Se tendrán en cuenta, si surgieran, casos especiales como: niños con TEA grado I-II-III (trastorno del espectro autista), niños con niveles de ansiedad muy altos condicionados por experiencias desagradables previas relacionadas con las agujas (hospitalizaciones, vías, …). Estos casos se serán valorados por el equipo coordinador
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.