Pain During Vaccine Administration

Not Applicable

Completed

• Conditions: Infant, Newborn, Pain
• Interventions: Behavioral: Palmar grasp reflex

• Registration Number: NCT05672303
• Lead Sponsor: Ataturk University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-05
• Primary Completion: 2023-03-30
• Study Completion: 2023-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Palmar grasp reflex	Palmar grasp reflex will be stimulated with routine procedure.

Primary Outcome Measures

Name	Time	Method
pain level will be measured in the premature baby	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 Outcome Measures

Name	Time	Method
Crying time	15 minutes	Crying time will be evaluated in seconds with a coronometer.

Trial Locations

Locations (1)

Türkan Kadiroğlu; 🇹🇷 Yakutiye, Erzurum, Turkey