Clinical trial NCT06377748: The Effect of Facilitated-tucking and ShotBlocker on Pain Caused by Vaccination in Healthy Infants
Official title: The Effect of Facilitated-tucking, ShotBlocker, and the Combination of the Facilitated-tucking and ShotBlocker on Pain Caused by Hepatitis-B Vaccination in Healthy Term Infants: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Pain, Acute
Nursing Caries
Keywords: Healthy infant
Nonpharmacological pain management
Procedural pain
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 142
Sex: ALL
Minimum age (years): 38
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to experimental and control groups using block randomization method. Birth weight (2500-3000 g, 3001-3500 g, 3501 g and above), gender (male and female) and mode of delivery (vaginal and cesarean section) variables will be used for block randomization.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants.

Detailed description: Hepatitis B vaccination is one of the painful procedures routinely performed in newborns. The pain experienced by the newborn negatively affects the prognosis of the disease, the infant's behavior, the harmony with the environment, the development of the brain and senses, as well as the family-infant interaction. Nonpharmacologic methods have been found to be effective in alleviating pain during interventions that cause pain caused by medical procedures that newborns frequently encounter. Facilitated tucking and ShotBlocker are effective methods that can be used in nonpharmacologic procedural pain management.

Studies have commonly used parent-related methods (kangaroo care, mother/father cuddling, breastfeeding, etc.) for neonatal pain management during Hepatitis B vaccine administration. In units where access to the parent is not always possible, nonpharmacologic pain methods that can be used independently of the parent can be used in the management of acute needle-related pain. In addition, no study was found in the literature comparing and combining the effect of fetal position and ShotBlocker application on hepatitis B vaccine-related pain. This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants.

Eligibility criteria: Inclusion Criteria:

* healthy term neonates
* born at 38-42 weeks gestational week,
* birth weight 2500-4400 g,
* 5th minute APGAR score above 6,
* in stable health,
* able to carry out vital activities without support,
* babies ordered Hepatitis B vaccine by the doctor

Exclusion Criteria:

* With a genetic or congenital anomaly,
* neurological, cardiological and metabolic diseases,
* in need of respiratory support,
* acute or chronic illness that causes pain,
* a complication of childbirth,
* infants of hepatitis B carrier mothers,
* nerve damage or deformity in the extremity to be vaccinated, scar tissue or incision in the vastus lateralis region,
* infants of mothers with a history of substance abuse

Primary outcomes:
measure: Neonatal Infant Pain Scale
timeFrame: 1 min before, during, 1 min after and 3 min after the painful procedure, an average of 4-5 minutes
Secondary outcomes:
measure: Crying time during the procedure
timeFrame: Through painful procedure completion, an average of 4 minutes
measure: Procedure time
timeFrame: Through painful procedure completion, an average of 60 seconds
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
state: Kadıköy
Study officials:
affiliation: Istanbul Medeniyet University
name: Aynur Aytekin Özdemir, PhD
role: STUDY_DIRECTOR
References:
citation: Avcin E, Kucukoglu S. The Effect of Breastfeeding, Kangaroo Care, and Facilitated Tucking Positioning in Reducing the Pain During Heel Stick in Neonates. J Pediatr Nurs. 2021 Nov-Dec;61:410-416. doi: 10.1016/j.pedn.2021.10.002. Epub 2021 Oct 20.
citation: Caglar S, Buyukyilmaz F, Cosansu G, Caglayan S. Effectiveness of ShotBlocker for Immunization Pain in Full-Term Neonates: A Randomized Controlled Trial. J Perinat Neonatal Nurs. 2017 Apr/Jun;31(2):166-171. doi: 10.1097/JPN.0000000000000256.
citation: Drago LA, Singh SB, Douglass-Bright A, Yiadom MY, Baumann BM. Efficacy of ShotBlocker in reducing pediatric pain associated with intramuscular injections. Am J Emerg Med. 2009 Jun;27(5):536-43. doi: 10.1016/j.ajem.2008.04.011.
citation: Kucukoglu S, Kurt S, Aytekin A. The effect of the facilitated tucking position in reducing vaccination-induced pain in newborns. Ital J Pediatr. 2015 Aug 21;41:61. doi: 10.1186/s13052-015-0168-9.