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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Other: Painless Vaccination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Quasi-experimental (non-randomized) controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (IG)<br>Welcoming the child and his or her guardians Invite them to participate, explain the study, and collect informed consent Recording of vaccinations in the medical record Safety check-list and identification Structural and environmental adaptation of the office Decorated nursing uniforms Use of distracting and rewarding elements according to age Preparation of vaccines out of sight of children Apply antalgic measures according to age and preferences. If the skin is dirty, clean it with physiological saline solution. Administer vaccines from least painful to most painful Only cover the puncture site if there is bleeding. Give post-vaccination recommendations Measure pain before, during and after vaccination with validated scales according to age | Other: Painless Vaccination<br>* 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<br>|
| No Intervention: Control group (CG)<br>The right 5+2 might be identified (patient, vaccine, interval, dose, route of administration, anatomical site, record) might be identified In infants, a non-pressing but secure breastfeeding position is recommended >3 years old: they sit on the tutor's lap, encouraging their collaboration to hold the child without compressing ensuring to avoid movements, and try to distract them 6-12 years old: they sit in the chair with the tutor sitting next to him/her and they are vaccinated asking for the child's collaboration. If necessary, they might be held to avoid movements Vaccines will be administered following The 2021 Vaccination Protocol Tutors will receive recommendations on adverse effects Queries might be solved The atmosphere of the immunization clinic is similar to the rest of the clinics in the health centre (white walls and no child decoration) The uniform used by the nurses is white and the vaccination techniques are the same as those previously used in these centres | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain immediately after injection | 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. | During the vaccination procedure | 
| Pain before leaving the office | 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. | During the vaccination procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccines, Pain Management, Primary Health Care, Infant, Child