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

NACompletedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

June 15, 2024

Primary Completion Date

September 30, 2024

Study Completion Date

September 30, 2024

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 After the procedure is completed and the needle is withdrawn, the ShotBlocker will be removed from the skin.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 After the injection is completed and the needle is withdrawn, the ShotBlocker will be removed from the skin.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

Trial Locations (1)

34720

Istanbul Medeniyet University, Istanbul

All Listed Sponsors
lead

Istanbul Medeniyet University

OTHER

NCT06377748 - The Effect of Facilitated-tucking and ShotBlocker on Pain Caused by Vaccination in Healthy Infants | Biotech Hunter | Biotech Hunter