Pain at Hepatitis B Vaccine in Preterm Infants

Sponsor

Ataturk University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05672303

Collaborator

MSc Elif Simay KOÇ (Other)

Enrollment

Location

Arms

3.9

Anticipated Duration (Months)

15.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Newborn, Pain	Behavioral: Palmar grasp reflex	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Pain and Crying Time in Hepatitis B Vaccine in Preterm Infants

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

pain level will be measured in the premature baby [12 week]
Premature Infant Pain Profile-PIPP: It is suitable for term and preterm infants and is used for the assessment of acute and procedural pain. Scoring ranges from 0 to 21. A score of 6 or less is considered as no or minimal pain, 7-12 points as moderate pain, and 13-21 points as severe pain. It is evaluated 15 seconds before the intervention and 30 seconds after the intervention.

Secondary Outcome Measures

crying time [12 week]
Crying time will be evaluated in seconds with a coronometer.

Eligibility Criteria

Criteria

Ages Eligible for Study:

32 Weeks to 37 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

32-37. born in gestational week
No congenital malformation
Not receiving mechanical ventilation support
No contraindications for hepatitis B vaccine administration
Stable vital signs before the procedure
Preterm infants who are not treated with analgesic sedation before the procedure

Exclusion Criteria:

• Infants of parents who did not give informed voluntary consent will not be included in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Türkan Kadiroğlu	Yakutiye	Erzurum	Turkey	25040

Sponsors and Collaborators

Ataturk University
MSc Elif Simay KOÇ

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Türkan Kadiroğlu, Pricipal Investigator, Ataturk University

ClinicalTrials.gov Identifier:

NCT05672303

Other Study ID Numbers:

Ataturk Uni

First Posted:

Jan 5, 2023

Last Update Posted:

Jan 5, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatitis B

Study Results

No Results Posted as of Jan 5, 2023