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

NCT06004258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 495

Last updated 2023-08-22

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Hospital Universitario Virgen Macarena

    lead OTHER

Principal Investigators

  • Eva Franco García, BSN · Servicio Andaluz de Salud- Distrito Sanitario Aljarafe-Sevilla Norte

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2023-04-03
Completion
2023-04-17

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06004258 on ClinicalTrials.gov