The experience of a vaccination is more painful for children than adults. This randomized experimental study aimed to evaluate the impact of ShotBlocker and manual pressure on pain reduction during administering pneumococcal conjugate vaccines (PCV) in infants. The study was performed with 102 4-month-old infants who received the PCV at 3 health centers. The participants were randomly assigned to 1 of the 3 groups: ShotBlocker, manual pressure, and control. Each group included 34 infants, with an equal distribution of genders. Data collection tools included a demographic questionnaire, the Neonatal Infant Pain Scale, and video recordings. The results indicated that neither manual pressure nor ShotBlocker effectively reduced pain during PCV administration in 4-month-old infants. No statistically significant difference was found in Neonatal Infant Pain Scale (NIPS) scores among the groups after vaccination (F = 0.789, P > .05). These results highlight the need specific approaches to nonpharmacological pain management during vaccination for 4-month-old infants.
Registration: Clinical trials number is NCT06813729 (ClinicalTrials.gov).
de MiguelSDomenechMGonzález-CamachoF, et al. Nationwide trends of invasive pneumococcal disease in Spain from 2009 through 2019 in children and adults during the pneumococcal conjugate vaccine era. Clin Infect Dis. 2021;73(11):e3778-e3787. doi:10.1093/cid/ciaa1483.
LeeVYCaillaudCFongJEdwardsKM.Improving vaccine-related pain, distress or fear in healthy children and adolescents–a systematic search of patient-focused interventions. Hum Vaccin Immunother. 2018;14(11):2737-2747. doi:10.1080/21645515.2018.1480238.
5.
MacDougallTCunninghamSWhitneyLSawhneyM.Improving pediatric experience of pain during vaccinations: a quality improvement project. Int J Health Care Qual Assur. 2019;32(6):1034-1040. doi:10.1108/IJHCQA-07-2018-0185.
6.
IgnisIOTominiS.Vaccination coverage: vaccine-related determinants & anthropometric measures in children resident in a rural community in Nigeria. Curr Drug Saf. 2021;17(3):199-210. doi:10.2174/1574886316666211029153212.
7.
IbrahimMAEHassanEA.Effect of teaching instructions for mothers about diphtheria, pertussis, and tetanus vaccine on ıts side effects and management. J Nurs Health Sci. 2018;7(2):71-80. doi:10.9790/1959-0702097180.
8.
Özalp GerçekerGAyarDÖzdemirEZBektaşM.Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5–12 years old: a randomised controlled study. J Clin Nurs. 2020;29(7-8):1151-1161. doi:10.1111/jocn.15173.
9.
HeshmatifarNSalariMRadMAfshari SalehTBorzoeeFRastaghiS.A new approach on the pain management of intramuscular injection: a triple-blind randomized clinical trial. Pain Manag Nurs. 2022;23(3):353-358. doi:10.1016/j.pmn.2021.01.010.
10.
MangatAKOeiJLChenKQuah-SmithISchmölzerGM.A review of non-pharmacological treatments for pain management in newborn infants. Children. 2018;5(10):130. doi:10.3390/children5100130.
11.
BucseaORiddellRP.Non-pharmacological pain management in the neonatal intensive care unit: managing neonatal pain without drugs. Semin Fetal Neonatal Med. 2019;24(4):101017. doi:10.1016/j.siny.2019.05.009.
12.
HatfieldLAMurphyNKarpKPolomanoRC.A systematic review of behavioral and environmental interventions for procedural pain management in preterm infants. J Pediatr Nurs. 2019;44:22-30. doi:10.1016/j.pedn.2018.10.004.
13.
KemerDİşlerA.Yenidoğanlarda ağrı yönetiminde kullanılan kanıt temelli nonfarmakolojik hemşirelik uygulamaları. Balıkesir Sağlık Bilimleri Dergisi. 2020;9(3):197-204.
14.
WuYZhaoYWuLZhangPYuG.Non-pharmacological management for vaccine-related pain in children in the healthcare setting: a scoping review. J Pain Res. 2022;15:2773-2782. doi:10.1108/IJHCQA-07-2018-0185.
15.
KaplanAGülerSAvşaroğullarıÖL.Comparison of manual pressure and ShotBlocker on pain and satisfactıon in intramuscular injectıon: a randomized controlled trial. J Health Sci. 2023;32(1):89-96. doi:10.34108/eujhs.1123965.
16.
Tok AydınSGüvenSD. The effect of shot blocker application on intramuscular injection pain in adults: a randomized controlled trial. Int J Nurs Didactics. 2020;10(3):01-04. doi:10.15520/ijnd.v10i03.2859.
17.
AyindeOHaywardRSRossJDC. The effect of intramuscular injection technique on injection associated pain; a systematic review and meta-analysis. PLoS ONE. 2021;16(5):e0250883. doi:10.1371/journal.pone.0250883.
18.
GürdapZCengizZ.Comparison of cold spray and ShotBlocker to reduce intramuscular injection pain: a randomized controlled trial. J Clin Pharm Ther. 2022;47(8):1249-1256. doi:10.1111/jcpt.13663.
19.
ŞahanSYildizA.The effect of ShotBlocker application on intramuscular injection pain in adults: a meta-analysis. Clin Nurs Res. 2022;31(5):820-825. doi:10.1177/10547738211021225.
20.
Aydın YılmazDÖzakar AkçaSPeltek KendirciHN. ShotBlocker or cold application; which one is more effective in reducing anxiety and pain associated with the intramuscular injection in children?: a randomized controlled trial. Bezmialem Sci. 2024;12(1):98-106. doi:10.14235/bas.galenos.2023.75010.
21.
ÖztürkDBaykaraZGKaradagAEyikaraE.The effect of the application of manual pressure before the administration of intramuscular injections on students’ perceptions of postinjection pain: a semi-experimental study. J Clin Nurs. 2017;26(11-12):1632-1638. doi:10.1111/jocn.13530.
22.
Şanlialp ZeyrekATakmakŞKurbanNKArslanS.Systematic review and meta-analysis: physical-procedural interventions used to reduce pain during intramuscular injections in adults. J Adv Nurs. 2019;75(12):3346-3361. doi:10.1111/jan.14183.
23.
BilgiçŞ. The comparison of the effectiveness of local ice and manual pressure application in decreasing pain related to intramuscular injection. Clin Exp Health Sci. 2021;11(2):302-307. doi:10.33808/clinexphealthsci.778676.
24.
SerenaCMCLordHVargeseSS, et al. Effectiveness of physical stimulation for reducing injection pain in adults receiving intramuscular injections: a systematic review and meta-analysis. JBI Evid Synth. 2023;21(2):373-400. doi:10.11124/JBIES-20-00590.
25.
KantEAkpinarRB.The effect of music and the pressure applied on pain induced by intramuscular injection. Int J Caring Sci. 2017;10(3):1313-1318.
26.
EllisPD.The Essential Guide to Effect Sizes. Statistical Power, Meta-Analysis, and the Interpretation of Research Results. Cambridge: Cambridge University Press; 2010.
27.
LawrenceJAlcockDMcGrathPKayJMacMurraySBDulbergC.The development of a tool to assess neonatal pain. Neonatal Netw. 1993;12(6):59-66.
28.
AkdovanT. Assessment of Pain in Healthy Neonates, Investigation of the Effects of Pacifying and Holding in the Arms [master’s thesis], İstanbul: Marmara University Health Sciences Institute; 1999:64-110.
29.
GölİAltuğ ÖzsoyS. Effects of rapid vaccine injection without aspiration and applying manual pressure before vaccination on pain and crying time in infants. Worldviews Evid Based Nurs. 2017;14(2):154-162. doi:10.1111/wvn.12206.
30.
IppMParkinPCLearNGoldbachMTaddioA.Order of vaccine injection and infant pain response. Arch Pediatr Adolesc Med. 2009;163(5):469-472. doi:10.1001/archpediatrics.2009.35.
31.
UnesiZAfshariGSalari DastgerdHGandomiM.The effect of ShotBlocker on vaccination pain in infants. J Hayat. 2021;27(3):278-289.
32.
KarabeyTKaragözoğluŞ.The effect of Helfer skin tap technique and ShotBlocker application on pain in deltoid muscle injection. Clin Exp Health Sci. 2021;11(4):721-726. doi:10.33808/clinexphealthsci.861801.
33.
BilgeSAydinAGunC, et al. Comparison of the efficacy of ShotBlocker and cold spray in reducing intramuscular injection-related pain in adults: a prospective, randomized, controlled trial. Saudi Med J. 2019;40(10):996-1002. doi:10.15537%2Fsmj.2019.10.24322.
34.
SalariMEstajiZAkramiRRadM.Comparison of skin traction, pressure, and rapid muscle release with conventional method on intramuscular injection pain: a randomized clinical trial. J Educ Health Promot. 2018;7:172. doi:10.4103/jehp.jehp_216_18.
35.
GirginBAGölİGözenDÇarikçiFKirmizibekmezH.Effects of applications manual pressure and ShotBlocker to reduce needle-related pain and fear in children with type 1 diabetes mellitus. J Pediatr Nurs. 2023;73:84-90. doi:10.1016/j.pedn.2023.08.024.
