NCT06004258

Reduction of Pain in Childhood Vaccination in the Primary Care Nurse Vaccination Consultation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 495 (actual)
• Sponsor: Hospital Universitario Virgen Macarena · Academic / Other
• Sex: All
• Age: 2 Months – 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
OTHER	Painless Vaccination	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

Timeline

• Start date: 2022-06-21
• Primary completion: 2023-04-03
• Completion: 2023-04-17
• First posted: 2023-08-22
• Last updated: 2023-08-22

Locations

1 site across 1 country: Spain