The Effect of Facilitated-tucking and ShotBlocker on Pain Caused by Vaccination in Healthy Infants

Pain, Acute Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06377748
• Other study ID #: 2023/02
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: April 2024
• Source: Istanbul Medeniyet University
• Contact: Aynur Aytekin Özdemir, PhD
• Phone: +902162804104
• Email: aynur.ozdemir[@]medeniyet.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 38 Weeks to 42 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Nursing Caries
• Pain, Acute
• Pain, Procedural
• Procedural Pain

Intervention

Other:
• Facilitated tucking position
Neonates in this group will be given facilitated tucking position (lower and upper extremities will be held in right lateral flexion position and midline) by a volunteer nurse one minute before the vaccination procedure. The nurse will administer intramuscular vaccine injection into the vastus lateralis region of the left leg of the infant in the facilitated tucking position according to routine practice.

Device:
• ShotBlocker
Immediately prior to the vaccination procedure, the nurse will place the protruding surface of the ShotBlocker on the neonate's vaccination procedure site (left leg vastus lateralis muscle). The nurse will continue to hold the ShotBlocker at the injection site by pressing against the skin for 20 seconds. At the end of the time, she will grasp the tissue with the ShotBlocker and inject the vaccine through the opening in the center. After the procedure is completed and the needle is withdrawn, the ShotBlocker will be removed from the skin.

Combination Product:
• Combined facilitated tucking and ShotBlocker
Neonates in this group will be given facilitated tucking position (lower and upper extremities will be held in right lateral flexion position and midline) by a volunteer nurse one minute before the vaccination procedure. The nurse will place the ShotBlocker on the procedure site and apply pressure to the skin for 20 seconds. At the end of the time, the nurse will grasp the tissue with the ShotBlocker and inject the vaccine through the central opening. After the injection is completed and the needle is withdrawn, the ShotBlocker will be removed from the skin. The newborn will continue to take facilitated tucking position until 1 minute after the ShotBlocker is removed.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	Istanbul	Kadiköy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Infant Pain Scale	The scale is used to assess procedural pain in neonates. It is a behavioral scale assessing five behavioral indicators (facial expression, cry, arms, legs, and state of alertness) and one physiological indicator (breathing patterns). Five items (facial expression, breathing pattern, arms, legs, and state of alertness) are scored as 0 (Good) or 1 (Bad), while one item (crying) is scored as 0 (Good), 1, or 2 (Bad). The total scale score ranges from 0 to 7, with higher scores indicating more pain.	1 min before, during, 1 min after and 3 min after the painful procedure, an average of 4-5 minutes
Secondary	Crying time during the procedure	Total crying time during the procedure is the time the newborn cries between 1 min before and 3 min after the painful procedure.	Through painful procedure completion, an average of 4 minutes
Secondary	Procedure time	For vaccine administration, it is the time between when the needle is inserted into the skin and when it is removed from the skin.	Through painful procedure completion, an average of 60 seconds