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

Istanbul Medeniyet University

Status: Completed

Conditions: Pain, Acute; Procedural Pain; Nursing Caries

Treatments: Combination Product: Combined facilitated tucking and ShotBlocker; Other: Facilitated tucking position; Device: ShotBlocker

Study type: Interventional

Funder types: Other

Identifiers

NCT06377748

2023/02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 38 to 42 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 4 patient groups

Facilitated tucking position

Experimental group

Description:

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

Treatment:

Other: Facilitated tucking position

ShotBlocker

Experimental group

Description:

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

Treatment:

Device: ShotBlocker

Combined facilitated tucking position and ShotBlocker

Experimental group

Description:

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

Treatment:

Combination Product: Combined facilitated tucking and ShotBlocker

Control

No Intervention group

Description:

The control group will receive routine Hepatitis B vaccination.