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Clinical Trials/NCT05672303
NCT05672303
Completed
N/A

The Effect of Grasp Reflex Stimulation on Pain During Vaccine Administration

Ataturk University1 site in 1 country59 target enrollmentNovember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Infant, Newborn, Pain
Sponsor
Ataturk University
Enrollment
59
Locations
1
Primary Endpoint
pain level will be measured in the premature baby
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
April 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Türkan Kadiroğlu

Pricipal Investigator

Ataturk University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Crying time(15 minutes)

Study Sites (1)

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