Clinical trial NCT06004258: Reduction of Pain in Childhood Vaccination in the Primary Care Nurse Vaccination Consultation
Official title: Effectiveness of the Painless Vaccination Protocol Versus Traditional Vaccination Methodology in Reducing Pain in Children Aged 2 Months to 14 Years. A Multicenter, Quasi-experimental (Non-randomized) Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Vaccines
Pain Management
Primary Health Care
Infant
Child
Lead sponsor: Hospital Universitario Virgen Macarena
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 495
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental (non-randomized) controlled study
Primary purpose: OTHER

Brief 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).

Detailed description: Administration of injectable vaccines is the most prevalent painful procedure in childhood-adolescence. Pain leads to decreased adherence to vaccination programs. There is scientific evidence on effective pharmacological and non-pharmacological interventions to reduce the pain associated with the act of vaccination. However, their application is scarce in our setting.

The aim of this study is to analyze the perception of pain during vaccination in the population aged 2 months to 14 years participating in the intervention group (IG) versus traditional vaccination (control group, CG).

Quasi-experimental study (non-randomized) with control group. The aforementioned population attending the primary care center for vaccination and whose guardian has given informed consent will be included. After training of the vaccination nurses of the GE and modifications of the environmental decoration, GE receives its vaccine in centers A and B; while in center C, the control group receives it in the traditional way.

The main outcome variables are: pain during and post-vaccination, and the independent variables: age of the child and guardian, sex, type of vaccine and antalgic measures, etc.

Descriptive, bivariate and logistic regression statistical analysis will be performed, following the application criteria of each test. IBM-SPSS-V26 software.

Approved by the Research Bioethics Committee. For the first time in our environment, an experimental study is developed in real practice on non-pharmacological analgesic measures in the process of infant vaccination. The reduction of pain perceived by the user will improve adherence to vaccination programs and other invasive techniques. The use of the "Painless Vaccination" protocol will favor the incorporation of evidence into clinical practice, as well as the adherence of professionals to low cost measures, for the humanization of child care. As a potential limitation, resistance to change by professionals is expected.

Eligibility criteria: 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

Primary outcomes:
measure: Pain immediately after injection
timeFrame: During the vaccination procedure
measure: Pain before leaving the office
timeFrame: During the vaccination procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Distrito Sanitario Aljarafe-Sevilla Norte
state: Andalucia
Study officials:
affiliation: Servicio Andaluz de Salud- Distrito Sanitario Aljarafe-Sevilla Norte
name: Eva Franco García, BSN
role: PRINCIPAL_INVESTIGATOR
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