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Pain During Vaccine Administration

A

Ataturk University

Status

Completed

Conditions

Infant, Newborn, Pain

Treatments

Behavioral: Palmar grasp reflex

Study type

Interventional

Funder types

Other

Identifiers

NCT05672303
B.30.2.ATA.0.01.00/277

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

28 to 36 weeks old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

59 participants in 2 patient groups

Control
No Intervention group
Description:
Routine procedure will be applied
Experimental
Experimental group
Description:
Palmar grasp reflex will be stimulated with routine procedure.
Treatment:
Behavioral: Palmar grasp reflex

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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