Pain at Hepatitis B Vaccine in Preterm Infants
Primary Purpose
Infant, Newborn, Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Palmar grasp reflex
Sponsored by
About this trial
This is an interventional supportive care trial for Infant, Newborn, Pain
Eligibility Criteria
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.
Sites / Locations
- Türkan Kadiroğlu
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Experimental
Arm Description
Routine procedure will be applied
Palmar grasp reflex will be stimulated with routine procedure.
Outcomes
Primary Outcome Measures
pain level will be measured in the premature baby
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
Crying time will be evaluated in seconds with a coronometer.
Full Information
NCT ID
NCT05672303
First Posted
January 3, 2023
Last Updated
May 3, 2023
Sponsor
Ataturk University
Collaborators
MSc Elif Simay KOÇ
1. Study Identification
Unique Protocol Identification Number
NCT05672303
Brief Title
Pain at Hepatitis B Vaccine in Preterm Infants
Official Title
Pain and Crying Time in Hepatitis B Vaccine in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
Collaborators
MSc Elif Simay KOÇ
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine procedure will be applied
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Palmar grasp reflex will be stimulated with routine procedure.
Intervention Type
Behavioral
Intervention Name(s)
Palmar grasp reflex
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain level will be measured in the premature baby
Description
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.
Time Frame
12 week
Secondary Outcome Measure Information:
Title
crying time
Description
Crying time will be evaluated in seconds with a coronometer.
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Türkan Kadiroğlu
City
Yakutiye
State/Province
Erzurum
ZIP/Postal Code
25040
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pain at Hepatitis B Vaccine in Preterm Infants
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