Effect of Nursing Interventions on Pain and Salivary Cortisol Levels During Heel Stick in Preterm Newborns

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age34-36
SponsorNamik Kemal University

About this trial

Babies born before the thirty-seventh gestational week are called preterm or premature. Most preterm newborns require Neonatal Intensive Care Unit (NICU) care depending on their gestational age and clinical condition. Although many painful invasive procedures are usually performed on newborns in the NICU, the most common procedure is heel prick. Heel prick is a painful and stressful procedure for the newborn. Neonates do not respond to pain verbally; they respond physiologically, behaviorally and hormonally. Physiologic responses of preterm infants to pain include increased heart and respiratory rate, increased blood pressure and intracranial pressure, decreased oxygenation, and sweating of palms. Among the hormonal symptoms caused by stress in newborns, the most commonly used biochemical method is the measurement of cortisol level. It is reported that there is a significant correlation between salivary and plasma cortisol levels and salivary cortisol level reflects plasma cortisol level. This method is particularly preferred because saliva sampling is much less stressful.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Mother 18 years of age or older

Mother is literate

Whether the mother gives birth naturally or by caesarean section

Uncomplicated pregnancy and birth history in mother

Disqualifiers

The baby has a fever

The baby receiving oxygen therapy,

The baby receiving antibiotic treatment

The baby has a congenital anomaly

Trial design

Design model

Parallel

Treatments tested in this trial

  • pacifier with breast milk

    Other intervention

    swaddling in the mother\'s lap together with giving a pacifier dipped in breast milk

  • heel heating

    Other intervention

    swaddling in the mother\'s lap together with local dry heat application

  • interventions combined

    Other intervention

    swaddling in the mother\'s lap together with giving a pacifier dipped in breast milk and heel heating

  • Control

    Other intervention

    swaddling the baby in the mother\'s lap

Treatment groups

18 Participants
are divided into 4 treatment groups
Group A: pacifier with breast milk groupExperimental treatment 1 intervention
Group B: heel heating groupExperimental treatment 1 intervention
Group C: combined intervention groupExperimental treatment 1 intervention
Group D: ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

Cardiac apex beat (HRV)

HRV will be evaluated before, during and after the heel blood collection. Each baby will be video recorded for 7-10 minutes before, during and after the procedure by the researcher.

Time frame
Through study completion, an average of 1 year.
2

Oxygen saturation (SpO2)

SpO2 will be evaluated before, during and after the heel blood collection. Each baby will be video recorded for 7-10 minutes before, during and after the procedure by the researcher. SpO2 will be recorded from this video recording.

Time frame
Through study completion, an average of 1 year
3

Crying time

The baby crying time will be monitored and recorded 5 minutes before the heel prick and 5 minutes during the heel prick

Time frame
Through study completion, an average of 1 year
4

Premature Infant Pain Profile Scale (PIPP-R)

The PIPP-R scale includes 3 behavioral (frowning, squeezing eyes, nasolabial groove), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral state and gestational age) items. In the scoring of the scale, items related to physiological and behavioral items are scored as 0,1,2,3 in each variable, reflecting the difference between baseline and treatment values. Items related to contextual items are scored as 3,2,1,0 before touching the baby. The babys pain is evaluated on a total score. Accordingly, the maximum score for newborns is 21. If the premature infant pain profile is between 0-6 points, the pain level in the infant is mild, between 7-12 points is moderate, and between 13-21 points is severe pain. Each baby will be video monitored and recorded for 7-10 minutes before, during and after the procedure. This video recording will be evaluated and recorded according to the Premature Infant Pain Profile Scale.

Time frame
Through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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