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Completed

NCT Number: NCT06004258

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

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).

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

2 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Distrito Sanitario Aljarafe-Sevilla Norte

Seville, Andalusia, 41008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Painless Vaccination

Other

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

Primary outcomes

  1. Pain immediately after injection

    Time frame: During the vaccination procedure

    It is expected to reduce by 20% the perception of pain during the vaccination act in the IG with respect to the CG. Defining the success of the interventions with an applicable Moderate-High pain measure from 0-3 (FLACCr Scale value 3-5 and 6), Wong-Baker Scale applicable from 3-7 years (Mild= 2; Moderate= 4-6) and Visual Analog Scale applicable from 6 years (Mild 0-2).

    We will proceed to distinguish the number of vaccines received by infants in the different visits/age group and the vaccines themselves, as some are more painful than others. The most painful vaccines: Triple Viral, Pneumococcal 13 and Human Papilloma Virus. The less painful vaccines: Hexavalent, Meningococcal C, and Tetravalent Meningococcal.

  2. Pain before leaving the office

    Time frame: During the vaccination procedure

    It is expected to reduce by 20% the perception of pain during the vaccination act in the IG with respect to the CG. Defining the success of the interventions with an applicable Moderate-High pain measure from 0-3 (FLACCr Scale value 3-5 and 6), Wong-Baker Scale applicable from 3-7 years (Mild= 2; Moderate= 4-6) and Visual Analog Scale applicable from 6 years (Mild 0-2).

    We will proceed to distinguish the number of vaccines received by infants in the different visits/age group and the vaccines themselves, as some are more painful than others. The most painful vaccines: Triple Viral, Pneumococcal 13 and Human Papilloma Virus. The less painful vaccines: Hexavalent, Meningococcal C, and Tetravalent Meningococcal.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Virgen Macarena

Other

Registry information

Official study 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

Acronym: NoVacPain

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2023
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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