Aşı Sırasındaki Ağrıyı Azaltmada Farklı Yöntemlerin Karşılaştırılması: Plasebo ve Kontrol Gruplu Randomize Bir Çalışma

Yıl 2025, Cilt: 18 Sayı: 1, 111 - 126

Zeliha Cengiz , Mürşide Zengin , Emriye Hilal Yayan , Elanur Vicnelioğlu

https://doi.org/10.46483/jnef.1620940

Öz

Giriş: Ağrı fizyolojik, davranışsal ve bilişsel işlevlerde bozulmaya neden olabilir. Aşı uygulaması gibi ağrılı işlemler sırasında farmakolojik ve non-farmakolojik yöntemler kullanarak algılanan ağrıyı azaltmak önemlidir.
Amaç: Bu araştırma aşı uygulaması sırasında farklı non-farmakolojik yöntemlerin ağrı yönetimindeki etkinliğini karşılaştırmak amacıyla yapıldı.
Yöntem: Plasebo ve kontrol gruplu randomize kontrollü çalışma, ShotBlocker® (n=35), ShotBlocker®-plasebo (n=35), sukroz (n=35), sukroz-plasebo (n = 35) ya da kontrol (n = 35) gruplarına rastgele atanan 175 bebekle yapıldı. Bebeklerin ağrı düzeyleri değerlendiriciler (hemşireler, ebeveynler ve gözlemci) tarafından aşı uygulaması öncesinde ve sırasında Neonatal Infant Pain Scale (NIPS) kullanılarak belirlendi.
Bulgular: Beş grup arasında bebeğin yaşı, kilosu, boyu ve cinsiyeti bakımından anlamlı bir fark yoktu. Ebeveynler, hemşireler ve gözlemcinin ShotBlocker®, sukroz, ShotBlocker®-plasebo, sukroz-plasebo ve kontrol grupları için belirledikleri ağrı skorları arasında istatistiksel olarak önemli farklılık vardı. ShotBlocker® ve sucrose grubundaki infantların ağrı skorları plasebo ve kontrol gruplarına göre istatistiksel olarak daha düşüktü (p<.001).
Sonuç: Tüm gözlemcilerin değerlenirmesinde ShotBlocker® ve sukroz kullanımının aşı sırasındaki ağrı düzeyini azalttığı ve bu iki yöntem arasında istatistiksel olarak anlamlı bir fark olmadığı sonucuna varıldı. Bebeklerde aşı uygulaması sırasında hissedilen ağrıyı en aza indirmek için sağlık profesyonellerinin (hemşire ve ebeler) bu yöntemleri klinik uygulamada kullanmaları önerilmektedir.

Anahtar Kelimeler

Bebek, Ağrı Yönetimi, ShotBlocker®, Sukroz, Aşı Uygulaması

Comparison of Different Methods for Reducing Pain during Vaccination: A Randomized Study with Placebo and Control Groups

Öz

Background: Pain can cause deterioration in physiological, behavioural, and cognitive functioning. It is important to reduce perceived pain during painful procedures such as vaccination using pharmacological and non-pharmacological methods.
Objectives: The study was carried out to compare the effectiveness of different non-pharmacological methods in pain management during vaccination.
Methods: This randomised controlled study with placebo and control groups was conducted with 175 infants, who were randomly assigned to one of the ShotBlocker® (n = 35), ShotBlocker®-placebo (n = 35), sucrose (n = 35), sucrose-placebo (n = 35) or control (n = 35) groups. Pain levels of the infants were determined by assessors (nurses, parents, and observer) using the Neonatal Infant Pain Scale (NIPS) before and during vaccination.
Results: There was no significant difference in infant age, weight, length, and gender among the five groups. There were statistically significant differences between the pain scores determined by the parents, nurses, and observer for the ShotBlocker®, sucrose, ShotBlocker®-placebo, sucrose-placebo, and control groups. The pain scores of infants in the ShotBlocker® and sucrose groups were statistically lower than those in the placebo and control groups (p < .001).
Conclusion: It was concluded that the use of ShotBlocker® and sucrose reduced pain levels during vaccination according to all observers and that there was no statistically significant difference between these two methods. In order to minimize the perceived pain in infants during vaccination it is recommended that healthcare professionals (nurses and midwives) would use these methods in clinical practice.

Anahtar Kelimeler

Infants, Pain Management, ShotBlocker®, Sucrose, Vaccination

Kaynakça

• Alpar, R. (2011). Spor, Sağlık ve Eğitim Bilimlerinde Örneklerle Uygulamalı İstatistik ve Geçerlik-Güvenirlik (2. Ba-sım). Detay Yayıncılık.
• Amiri Shadmehri, E., Yaghoobi, H., Sajjadi, M., & Abbasian, M. (2020). The Effect of the Smell of Breast Milk and Non-Nutritious Sucking on Pain Behavioral Response and to First-Time Hepatitis B Vaccine in Term Newborns. The Open Nursing Journal, 14(1), 141–147. https://doi.org/10.2174/1874434602014010141
• Aydin, E., & Avşar, G. (2019). Examining the effect of “Shotblocker” in relieving pain associated with intramuscu-lar injection. Complementary Therapies in Medicine, 47, 102192. https://doi.org/10.1016/j.ctim.2019.09.001
• Benoit, B., Martin-Misener, R., Latimer, M., & Campbell-Yeo, M. (2017). Breast-feeding analgesia in infants. Jour-nal of Perinatal and Neonatal Nursing, 31(2), 145–159. https://doi.org/10.1097/JPN.0000000000000253
• Binay, Ş., Bilsin, E., Gerçeker, G., Kahraman, A., & Bal-Yılmaz, H. (2019). Comparison of the Effectiveness of Two Different Methods of Decreasing Pain During Phlebotomy in Children: A Randomized Controlled Trial. Jour-nal of Perianesthesia Nursing. https://doi.org/10.1016/j.jopan.2018.11.010
• Caglar, S., Büyükyilmaz, F., Coşansu, G., & Çaǧlayan, S. (2017). Effectiveness of ShotBlocker for immunization pain in full-term neonates: A randomized controlled trial. Journal of Perinatal and Neonatal Nursing, 31(2), 166–171. https://doi.org/10.1097/JPN.0000000000000256
• Canbulat Sahiner, N., Turkmen, A. S., Acikgoz, A., Simsek, E., & Kirel, B. (2018). Effectiveness of Two Different Methods for Pain Reduction During Insulin Injection in Children With Type 1 Diabetes: Buzzy and ShotBlocker. Worldviews on Evidence-Based Nursing, 15(6), 464–470. https://doi.org/10.1111/wvn.12325
• Celebioglu, A., Akpinar, R. B., & Tezel, A. (2010). The pain response of infants in Turkey to vaccination in differ-ent injection sites. Applied Nursing Research, 23(2), 101–105. https://doi.org/10.1016/j.apnr.2008.03.003
• Çelik, N., & Khorshid, L. (2015). The Use of ShotBlocker for Reducing the Pain and Anxiety Associated With In-tramuscular Injection. Holistic Nursing Practice, 29(5), 261–271. https://doi.org/10.1097/HNP.0000000000000105
• Centers for Disease Control and Prevention. (2010). Recommended Immunization Schedules for Persons Aged 0 Through 18 Years. http://www.cdc.gov/vaccines/pubs/vis/default.htm.
• Cobb, J. E., & Cohen, L. L. (2009). A Randomized Controlled Trial of the ShotBlocker for Children’s Immunization Distress. Clinical Journal of Pain, 25(9), 790–796. https://doi.org/10.1097/AJP.0b013e3181af1324
• Cohen, J. (1988). Statistical power analysis for the behavioral sciences. Lawrence Erlbaum Associates Publishers.
• Curry, D. M., Brown, C., & Wrona, S. (2012). Effectiveness of Oral Sucrose for Pain Management in Infants Dur-ing Immunizations. Pain Management Nursing, 13(3), 139–149. https://doi.org/10.1016/j.pmn.2010.07.008
• DeMore, M., & Cohen, L. L. (2005). Distraction for pediatric immunization pain: A critical review. Journal of Clini-cal Psychology in Medical Settings, 12(4), 281–291. https://doi.org/10.1007/s10880-005-7813-1
• Despriee, Å. W., & Langeland, E. (2016). The effect of sucrose as pain relief/comfort during immunisation of 15-month-old children in health care centres: A randomised controlled trial. Journal of Clinical Nursing, 25(3–4), 372–380. https://doi.org/10.1111/jocn.13057
• Drago, L. A., Singh, S. B., Douglass-Bright, A., Yiadom, M. Y., & Baumann, B. M. (2009). Efficacy of ShotBloc-ker in reducing pediatric pain associated with intramuscular injections. The American Journal of Emergency Medici-ne, 27(5), 536–543. https://doi.org/10.1016/j.ajem.2008.04.011
• Gao, H., Gao, H., Xu, G., Li, M., Du, S., Li, F., Zhang, H., & Wang, D. (2016). Efficacy and safety of repeated oral sucrose for repeated procedural pain in neonates: A systematic review. In International Journal of Nursing Studies (Vol. 62, pp. 118–125). Elsevier Ltd. https://doi.org/10.1016/j.ijnurstu.2016.07.015
• Girgin, B. A., Göl, İ., Gözen, D., Çarikçi, F., & Kirmizibekmez, H. (2023). Effects of applications manual pressure and shotblocker to reduce needle-related pain and fear in children with type 1 diabetes mellitus. Journal of Pediatric Nursing, 73(August), 84–90. https://doi.org/10.1016/j.pedn.2023.08.024
• Gray, P. H., Trotter, J. A., Langbridge, P., & Doherty, C. V. (2006). Pain relief for neonates in Australian hospitals: A need to improve evidence-based practice. Journal of Paediatrics and Child Health, 42(1–2), 10–13. https://doi.org/10.1111/j.1440-1754.2006.00782.x
• Gürdap, Z., & Cengiz, Z. (2022). Comparison of cold spray and shotblocker to reduce intramuscular injection pain: A randomized controlled trial. Journal of Clinical Pharmacy and Therapeutics, 47(8), 1249–1256. https://doi.org/10.1111/jcpt.13663
• Harrison, D, Johnston, L., & Loughnan, P. (2003). Oral sucrose for procedural pain in sick hospitalized infants: A randomized-controlled trial. Journal of Paediatrics and Child Health, 39(8), 591–597. https://doi.org/10.1046/j.1440-1754.2003.00242.x
• Harrison, Denise, Larocque, C., Bueno, M., Stokes, Y., Turner, L., Hutton, B., & Stevens, B. (2017). Sweet Soluti-ons to Reduce Procedural Pain in Neonates: A Meta-analysis. Pediatrics, 139(1), e20160955. https://doi.org/10.1542/peds.2016-0955
• Harrison, Denise, Reszel, J., Bueno, M., Sampson, M., Shah, V. S., Taddio, A., Larocque, C., & Turner, L. (2016). Breastfeeding for procedural pain in infants beyond the neonatal period. In Cochrane Database of Systematic Re-views (Vol. 2016, Issue 10). John Wiley and Sons Ltd. https://doi.org/10.1002/14651858.CD011248.pub2
• Karakaya, A., & Gözen, D. (2016). The Effect of Distraction on Pain Level Felt by School-age Children During Ve-nipuncture Procedure—Randomized Controlled Trial. Pain Management Nursing, 17(1), 47–53. https://doi.org/10.1016/j.pmn.2015.08.005
• Kassab, M., Almomani, B., Nuseir, K., & Alhouary, A. a. (2020). Efficacy of Sucrose in Reducing Pain during Im-munization among 10- to 18-Month-Old Infants and Young Children: A Randomized Controlled Trial. Journal of Pediatric Nursing, 50, e55–e61. https://doi.org/10.1016/J.PEDN.2019.11.010
• Kassab, M., Sheehy, A., King, M., Fowler, C., & Foureur, M. (2012). A double-blind randomised controlled trial of 25% oral glucose for pain relief in 2-month old infants undergoing immunisation. International Journal of Nursing Studies, 49(3), 249–256. https://doi.org/10.1016/j.ijnurstu.2011.09.013
• Kumar, A., Narang, G. S., Singh, G., & Kaur, J. (2019). Comparison of the effectiveness of oral sucrose solution and topical anaesthetics during immunization in infants between age 6 weeks-6 months. International Journal of Contemporary Pediatrics, 6(3), 1008. https://doi.org/10.18203/2349-3291.ijcp20191021
• Lacey M Eden, Macintosh, J. L., Luthy, K. E., & Beckstrand, R. L. (2014). Minimizing pain during childhood vac-cination injections : improving adherence to vaccination schedules. Pediatrict Health, Medicine and Therapeutics, 5, 127–140. https://doi.org/https://doi.org/10.2147/PHMT.S50510
• Liu, Y., Huang, X., Luo, B., & Peng, W. (2017). Effects of combined oral sucrose and nonnutritive sucking (NNS) on procedural pain of NICU newborns, 2001 to 2016. Medicine, 96(6), 6108. https://doi.org/10.1097/MD.0000000000006108
• Matsuda, E. (2017). Sucrose as Analgesia in Neonates Undergoing Painful Procedures. American Journal of Nursing, 117(8), 21. https://doi.org/10.1097/01.NAJ.0000521966.23470.7d
• Meek, J., & Huertas, A. (2012). Cochrane review: non-nutritive sucking, kangaroo care and swaddling/facilitated tucking are observed to reduce procedural pain in infants and young children. Evidence-Based Nursing, 15(3), 84–85. https://doi.org/10.1136/EBNURS-2011-100453
• Reis, E. C., Roth, E. K., Syphan, J. L., Tarbell, S. E., & Holubkov, R. (2002). Effective pain reduction for multiple immunization injections in young infants. Pediatric Research, 51(4 CC-HS-HANDSRCH CC-Child Health CC-Pain, Palliative and Supportive Care CC-Neonatal), 1115–1120.
• Savcı, C., Özkan, B., Açıksarı, K., & Solakoğlu, G. A. (2022). Effectiveness of Two Different Methods on the Perce-ived Pain and Satisfaction During Intramuscular Antibiotic Injection: ShotBlocker and Local Vibration. Clinical Nursing Research, 31(5), 812–819. https://doi.org/10.1177/10547738211051877
• Shah, P. S., Herbozo, C., Aliwalas, L. L., & Shah, V. S. (2012). Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database of Systematic Reviews, 12. https://doi.org/10.1002/14651858.CD004950.pub3
• Sivri, B. B., Balci, S., & Dolgun, G. (2023). The Effect of 3 Methods (Buzzy, ShotBlocker, and DistrACTION Cards) Used while Taking Blood Samples from Children with Pain and Anxiety: A Randomized Controlled Trial. Pediatric Emergency Care, 39(8), 600–607. https://doi.org/10.1097/PEC.0000000000002866
• Sivri Bilgen, B., & Balcı, S. (2019). The Effect on Pain of Buzzy® and ShotBlocker® during the Administration of Intramuscular Injections to Children: A Randomized Controlled Trial. Journal of Korean Academy of Nursing, 49(4), 486. https://doi.org/10.4040/jkan.2019.49.4.486
• Stevens, B., Yamada, J., Campbell-Yeo, M., Gibbins, S., Harrison, D., Dionne, K., Taddio, A., McNair, C., Willan, A., Ballantyne, M., Widger, K., Sidani, S., Estabrooks, C., Synnes, A., Squires, J., Victor, C., & Riahi, S. (2018). The minimally effective dose of sucrose for procedural pain relief in neonates: A randomized controlled trial. BMC Pediatrics, 18(1), 85. https://doi.org/10.1186/s12887-018-1026-x
• Stevens, B., Yamada, J., Ohlsson, A., Haliburton, S., & Shorkey, A. (2016). Sucrose for analgesia in newborn in-fants undergoing painful procedures. Cochrane Database of Systematic Reviews, 7(7). https://doi.org/10.1002/14651858.CD001069.pub5
• Taddio, A., Ilersich, A. L., Ipp, M., Kikuta, A., & Shah, V. (2009). Physical interventions and injection techniques for reducing injection pain during routine childhood immunizations: Systematic review of randomized controlled trials and quasi-randomized controlled trials. In Clinical Therapeutics (Vol. 31, Issue SUPPL. 2). Clin Ther. https://doi.org/10.1016/j.clinthera.2009.07.024
• Taddio, A., Pillai, R. R., Ipp, M., Moss, S., Baker, S., Tolkin, J., Malini, D., Feerasta, S., Govan, P., Fletcher, E., Wong, H., McNair, C., Mithal, P., & Stephens, D. (2017). Relative effectiveness of additive pain interventions du-ring vaccination in infants. CMAJ, 189(6), E227–E234. https://doi.org/10.1503/cmaj.160542
• Taddio, A., Shah, V., Hancock, R., Smith, R. W., Stephens, D., Atenafu, E., Beyene, J., Koren, G., Stevens, B., & Katz, J. (2008). Effectiveness of sucrose analgesia in newborns undergoing painful medical procedures. Cmaj, 179(1), 37–43. https://doi.org/10.1503/cmaj.071734
• Uzelli, D., & Yapucu Güneş, Ü. (2015). Oral glucose solution to alleviate pain induced by intramuscular injections in preterm infants. Journal for Specialists in Pediatric Nursing, 20(1), 29–35. https://doi.org/10.1111/jspn.12094
• WHO. (2015). Vaccinations made friendly. WHO; World Health Organization. https://www.who.int/features/2015/vaccinations-made-friendly/en/
• Yilmaz, G., Caylan, N., Oguz, M., & Karacan, C. D. (2014). Oral sucrose administration to reduce pain response during immunization in 16–19-month infants: a randomized, placebo-controlled trial. European Journal of Pediat-rics, 173(11), 1527–1532. https://doi.org/10.1007/s00431-014-2358-7
• Yilmaz Kurt, F., Aytekin Ozdemir, A., & Atay, S. (2019). The Effects of Two Methods on Venipuncture Pain in Children: Procedural Restraint and Cognitive-Behavioral Intervention Package. Pain Management Nursing. https://doi.org/10.1016/j.pmn.2019.09.002