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Pain During Vaccine Administration

The Effect of Grasp Reflex Stimulation on Pain During Vaccine Administration

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05672303
Enrollment
59
Registered
2023-01-05
Start date
2022-11-01
Completion date
2023-04-01
Last updated
2024-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Newborn, Pain

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.

Interventions

BEHAVIORALPalmar 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.

Sponsors

MSc Elif Simay KOÇ
CollaboratorUNKNOWN
Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 36 Weeks
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.

Design outcomes

Primary

MeasureTime frameDescription
pain level will be measured in the premature baby15 minutesPIPP-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

MeasureTime frameDescription
Crying time15 minutesCrying time will be evaluated in seconds with a coronometer.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026