Reduction of Pain in Childhood Vaccination in the Primary Care Nurse Vaccination Consultation
Condition: Pain
Study type: Interventional

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.
    

Intervention name(s): Painless Vaccination
Intervention type(s): Other
Intervention description(s): Structural adaptation of the vaccination areas and cozy decoration (colorful room, mobiles to hang on the ceiling) Nursing uniforms decorated with children's pictures Introduction of toys, stuffed animals, stamps and reward stickers, drawings and crayons, soothing music in the background
Antalgic measures by age ranges:
0-6M (FLACC scale) Breastfeed for two minutes if infant is breastfeeding Glucose 33% or 50% or if rotavirus vaccination, on mother's pacifier or gloved finger (non-nutritive sucking) Comfort between vaccinations 6-15M (FLACC scale) Position infant sitting on guardian's lap facing forward Distraction techniques: stuffed animals, toys, audiovisual devices 3-6Y (Wong-Baker scale) Involve child, explain Child sits on tutor's lap facing forward Distraction techniques: audiovisual devices, drawings 6-14Y (VAS scale)Always seated. Distraction method: audio-visual devices, breathing
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Quasi-experimental (non-randomized) controlled study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Vaccines; Pain Management; Primary Health Care; Infant; Child