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

NCT06377748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2024-10-16

No results posted yet for this study

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

Interventions

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 After the procedure is completed and the needle is withdrawn, the ShotBlocker will be removed from the skin.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 After the injection is completed and the needle is withdrawn, the ShotBlocker will be removed from the skin.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.

Sponsors & Collaborators

  • Istanbul Medeniyet University

    lead OTHER

Principal Investigators

  • Aynur Aytekin Özdemir, PhD · Istanbul Medeniyet University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
38 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06377748 on ClinicalTrials.gov