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Completed

NCT Number: NCT06377748

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

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.

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Key information

Conditions

Procedural Pain Acute Pain Neurologic Manifestations Nursing Caries Pain Pain, Acute Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

38 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medeniyet University

Istanbul, Kadıköy, 34720, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Positioning

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.

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.

Primary outcomes

  1. Neonatal Infant Pain Scale

    Time frame: 1 min before, during, 1 min after and 3 min after the painful procedure, an average of 4-5 minutes

    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.

Secondary outcomes

  1. Crying time during the procedure

    Time frame: Through painful procedure completion, an average of 4 minutes

    Total crying time during the procedure is the time the newborn cries between 1 min before and 3 min after the painful procedure.

  2. Procedure time

    Time frame: Through painful procedure completion, an average of 60 seconds

    For vaccine administration, it is the time between when the needle is inserted into the skin and when it is removed from the skin.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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