Pain During Vaccine Administration

NCT05672303 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/277
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Newborn, Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Crying time

  15 minutes

Study Arms (2)

Control

NO INTERVENTION

Routine procedure will be applied

Experimental

EXPERIMENTAL

Palmar grasp reflex will be stimulated with routine procedure.

Behavioral: Palmar grasp reflex

Interventions

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.

Experimental

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead
• MSc Elif Simay KOÇ: collaborator

Study Sites (1)

Türkan Kadiroğlu

Yakutiye, Erzurum, 25040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal Investigator

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: November 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: April 1, 2023
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)