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

NCT06377748 | Completed

• 1 other identifier: 2023/02
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain; Pain, Acute; Nursing Caries

Keywords

Healthy infant; Nonpharmacological pain management; Procedural pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Crying time during the procedure

  Through painful procedure completion, an average of 4 minutes

• Procedure time

  Through painful procedure completion, an average of 60 seconds

Study Arms (4)

Facilitated tucking position

EXPERIMENTAL

Newborns in this group will take the facilitated tucking position during routine Hepatitis B vaccine administration.

Other: Facilitated tucking position

ShotBlocker

EXPERIMENTAL

ShotBlocker will be used during routine Hepatitis B vaccine administration of newborns in this group.

Device: ShotBlocker

Combined facilitated tucking position and ShotBlocker

EXPERIMENTAL

Neonates in this group will take facilitated tucking position during routine Hepatitis B vaccine administration and ShotBlocker will be used during the procedure.

Combination Product: Combined facilitated tucking and ShotBlocker

Control

NO INTERVENTION

The control group will receive routine Hepatitis B vaccination.

Interventions

Facilitated tucking position OTHER

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.

Also known as: Positioning

Facilitated tucking position

ShotBlocker DEVICE

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.

ShotBlocker

Combined facilitated tucking and ShotBlocker COMBINATION_PRODUCT

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.

Combined facilitated tucking position and ShotBlocker

Eligibility Criteria

• Age: 38 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Kadıköy, 34720, Turkey (Türkiye)

Location

Related 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.

  PMID: 34687988 BACKGROUND

• 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.

  PMID: 28437308 BACKGROUND

• 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.

  PMID: 19497458 BACKGROUND

• 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.

  PMID: 26293573 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural; Acute Pain

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Aynur Aytekin Özdemir, PhD

  Istanbul Medeniyet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Using the block randomization technique, participants will be divided into 4 groups. A web-based randomization list creation tool will be used to create the blocked randomization list. Control and intervention groups will be coded as A, B, C and D using the sealed envelope method. Randomization information will be kept from the researcher involved in data collection until data collection begins. The researcher will learn which group each baby is in just before the application (researcher blinding). Parents will know which group the baby is in within the scope of the research. By the nature of the sample group, babies are blind. Research data will be entered into the computer database by coding the group name as A, B, C and D, and statistical analysis will be performed using this coding (statistician blinding).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: June 15, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: January through March of 2025
• Access Criteria: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.

Locations

TU (1)