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PainNoVacPainNCT06004258

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

A study testing Painless Vaccination in people with Pain, run by Hospital Universitario Virgen Macarena at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 2 months to 14 yearsHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Painless Vaccination
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
495 participants
Where
1 siteSpain
Study dates
21 Jun 2022to 17 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 months to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Distrito Sanitario Aljarafe-Sevilla Norte

    Seville, Andalusia, 41008

Other trials in Spain

About this study

Official 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

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).

Read the 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
Being tested
Painless Vaccination
Keywords
Vaccines, Pain Management, Primary Health Care, Infant, Child
Medical subject headings
Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Painless VaccinationOther

    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

Study groups in NCT06004258
Study groupRoleWhat they receive
Intervention group (IG)ExperimentalWelcoming 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
Receives: Other: Painless Vaccination
Control group (CG)No interventionThe "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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the vaccination procedure

  2. 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.

    Measured: During the vaccination procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study start21 Jun 2022
  3. Primary completion3 Apr 2023
  4. Study completion17 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Quasi-experimental (non-randomized) controlled study
Masking
None (open label)
Enrolment
495 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06004258
Sponsor's protocol ID
PI_EFG_2022
Acronym
NoVacPain
Status last verified
Jun 2023
First submitted
16 Aug 2023
Last updated
22 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • European Centre for Disease Prevention and Control- Public Health Guidance. Revised 2016. Let´s talk about protection. Enchancing childhoot vaccination update.

  • García Sánchez N, Merino Moína M, García Vera C, Lacarta García I, Carbonell Muñoz L, Pina Marqués B, et al. Alivio del dolor y el estrés al vacunar. Síntesis de la evidencia: recomendaciones del Comité Asesor de Vacunas de la AEP. Pediatría Atención Primaria. 2015;17(68):317-27.

  • Birnie KA, Noel M, Chambers CT, Uman LS, Parker JA. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005179. doi: 10.1002/14651858.CD005179.pub4.

    PubMed 30284240

  • Taddio A, McMurtry CM, Shah V, Riddell RP, Chambers CT, Noel M, MacDonald NE, Rogers J, Bucci LM, Mousmanis P, Lang E, Halperin SA, Bowles S, Halpert C, Ipp M, Asmundson GJG, Rieder MJ, Robson K, Uleryk E, Antony MM, Dubey V, Hanrahan A, Lockett D, Scott J, Bleeker EV; HELPinKids&Adults. Reducing pain during vaccine injections: clinical practice guideline. CMAJ. 2015 Sep 22;187(13):975-982. doi: 10.1503/cmaj.150391. Epub 2015 Aug 24. No abstract available.

    PubMed 26303247

  • Centers for Diseases Control and Prevention. Epidemiology and Precention of Vaccine- Preventible Diseases.The Pink Book:Course text book- - 14.ª edición (2021) Epidemiología y Prevención de Enfermedades Prevenibles por Vacunación.

  • Wallace AS, Mantel C, Mayers G, Mansoor O, Gindler JS, Hyde TB. Experiences with provider and parental attitudes and practices regarding the administration of multiple injections during infant vaccination visits: lessons for vaccine introduction. Vaccine. 2014 Sep 15;32(41):5301-10. doi: 10.1016/j.vaccine.2014.07.076. Epub 2014 Aug 1.

    PubMed 25092632

  • García Sánchez N, García SN, Hernández MA. Nuevos retos en vacunación. AEPap (ed.). Curso de Actualización Pediatría, 2017. Madrid: Lúa Ediciones 3.0; 2017. pp. 419-32

  • Taddio A, Ilersich AF, Ilersich AN, Wells J. From the mouth of babes: Getting vaccinated doesn't have to hurt. Can J Infect Dis Med Microbiol. 2014 Jul;25(4):196-200. doi: 10.1155/2014/470261.

    PubMed 25285123

  • . Pardo Calderón HE, Yataco Chamorro RN. Efectividad de las técnicas no farmacológicas para el alivio del dolor postvacunal en los niños menores de 5 años [Internet]. Universidad Privada Norbert Wiener; 2018. Available from: http://repositorio.uwiener.edu.pe/bitstream/handle/123456789/2166/TITULO - Hilda Erika Pardo Calderón.pdf?sequence=1&isAllowed=y

  • M. Ávila Carrasco a , L. Carbonell Muñoz a, A. Gómez Merino a, M. Méndez Perruca b, M.J. Rodríguez Besada b ¿Pueden los enfermeros de Atención Primaria contribuir en la disminución del dolor al vacunar? .Vacunas Volume 19, Issue 1, January-June 2018, Pages 8- 11

  • Tomás Rojas J, Benítez Muñoz N, Menéndez Sotillos MI, Portellano Soriano MI, Caballero Aguilera F, Palomares Ojeda L. Vacunación en el Siglo XXI . Menos dolor , mejor ambiente , seguridad y confort. Garnata 91 [Internet]. 2020;22:1-7. Available from: http://www.ciberindex.com/index.php/g91/article/view/e202313/e202313

  • Miranda C. Sanchez, et col. Tetanalgesia durante la vacunación de lactantes en atención primaria. Biblioteca Las Casa. http//www.index-f.com/lascasas/documentos/lc0874.php.2016.

  • Harrison D, Reszel J, Bueno M, Sampson M, Shah VS, Taddio A, Larocque C, Turner L. Breastfeeding for procedural pain in infants beyond the neonatal period. Cochrane Database Syst Rev. 2016 Oct 28;10(10):CD011248. doi: 10.1002/14651858.CD011248.pub2.

    PubMed 27792244

  • Eden, L., et cols.. Minimizar el dolor durante las inyecciones de vacunación infantil: la mejora de la adherencia a los programas de vacunación. https://doi.org/10.2147/PHMT.S50510. 2014

  • González-María E, Fuentelsaz-Gallego C, Moreno-Casbas T, Gil-Rubio P, Herreros-López P en nombre del grupo de trabajo de la G para el manejo del dolor en niños con cáncer. Guía de Práctica Clínica para el manejo del dolor en niños con cáncer [Internet]. 1a. Madrid, España: Investen; 2013. 142 p. Available from: http://www.criscancer.org

Questions about this trial

What is this clinical trial studying?

A study testing Painless Vaccination in people with Pain, run by Hospital Universitario Virgen Macarena at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain immediately after injection (time frame: During the vaccination procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06004258, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.

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