The Effect of Grasp Reflex Stimulation on Pain During Vaccine Administration
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ataturk University
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- pain level will be measured in the premature baby
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 28 Weeks to 36 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Control
Routine procedure will be applied
Experimental
Palmar grasp reflex will be stimulated with routine procedure.
Intervention: Palmar grasp reflex (Behavioral)
Outcomes
Primary Outcomes
pain level will be measured in the premature baby
Time Frame: 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 Outcomes
- Crying time(15 minutes)
Investigators
Türkan Kadiroğlu
Pricipal Investigator
Ataturk University