Pain During Vaccine Administration

The Effect of Grasp Reflex Stimulation on 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.

Study Overview

• Status: Completed
• Conditions: Infant, Newborn, Pain
• Intervention / Treatment: Behavioral: Palmar grasp reflex

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum
    • Yakutiye, Erzurum, Turkey, 25040
      • Türkan Kadiroğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 8 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Routine procedure will be applied
Experimental: Experimental; Palmar grasp reflex will be stimulated with routine procedure.	Behavioral: Palmar grasp reflex; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain level will be measured in the premature baby	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.	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crying time	Crying time will be evaluated in seconds with a coronometer.	15 minutes

Collaborators and Investigators

• Sponsor: Ataturk University
• Collaborators: MSc Elif Simay KOÇ

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis; Hepatitis B
• Other Study ID Numbers: B.30.2.ATA.0.01.00/277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No