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OpenTrials
Completed

NCT Number: NCT05672303

Pain During Vaccine Administration

Many painful interventions that cause pain and stress are applied to preterm babies in the neonatal intensive care unit for diagnosis and treatment. In neonatal care and reduction of acute interventional pain; Non-pharmacological methods including behavioral, psychological and environmental regulations should be used.

In the hepatitis B vaccine administered to preterm babies, stimulating the grasping reflex can make the preterm baby feel safe and calm. In the literature, there are many studies aimed at reducing pain in preterm newborns. However, no study has been found on the effect of grasping reflex stimulation on pain and crying in hepatitis B vaccine administration to preterm infants.

This study was planned to examine the effect of grasping reflex on pain and crying duration in preterm infants with hepatitis B vaccine.

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Key information

Conditions

Infant, Newborn, Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

28 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Türkan Kadiroğlu

Yakutiye, Erzurum, 25040, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 28-36 gestational week
  • No congenital malformation
  • follow up with a diagnosis of respiratory distress syndrome,
  • receive oxygen support with a nasal cannula or tube,
  • not receive mechanical ventilation support,
  • no contraindications for hepatitis B vaccine administration,
  • stable vital signs before vaccination,
  • not receive analgesic sedation treatment
  • whose parents give verbal and written consent to participate in the study.

Exclusion criteria

  • Infants of parents who did not give informed voluntary consent will not be included in the study.
  • Decreased oxygen saturation levels
  • Tachycardia just before the vaccine administration
  • Invasive intervention in the right hand.

Treatment and study plan

Palmar grasp reflex

Behavioral

The reflex can be stimulated by moving an object distally across the palm. In the study, at the beginning of the vaccine administration, the right hand of the infant will be moved distally along the palm with the researcher's index finger, thus providing reflex stimulation.

Primary outcomes

  1. pain level will be measured in the premature baby

    Time frame: 15 minutes

    PIPP-R Form: The PIPP scale, developed by Stevens et al. in 1996, is a validated assessment tool used to evaluate acute pain experienced by preterm infants during interventional procedures (Stevens et al., 1996). This scale was revised by Stevens et al. in 2014 (Stevens et al., 2014). The PIPP-R was adapted into Turkish in 2019 (Taplak, & Bayat, 2019). PIPP-R consists of behavioral subscales such as frowning, squeezing eyes, nasolabial furrow, physiological and behavioral status including heart rate and SPO2, and contextual subscales such as gestational age.

Secondary outcomes

  1. Crying time

    Time frame: 15 minutes

    Crying time will be evaluated in seconds with a coronometer.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Collaborators

  • MSc Elif Simay KOÇ

Registry information

Official study title

The Effect of Grasp Reflex Stimulation on Pain During Vaccine Administration

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2023
Registry last updated
May 28, 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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