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

NCT06628232 | Not Yet Recruiting

• 1 other identifier: TNKU-Z.BALKAN-2
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

PreTerm Neonate

Keywords

preterm; leel prick; pain; salivary cortisol; nursing care

Outcome Measures

Primary Outcomes (5)

• 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.

  Through study completion, an average of 1 year.

• 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.

  Through study completion, an average of 1 year

• Crying time

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

  Through study completion, an average of 1 year

• 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.

  Through study completion, an average of 1 year

• Salivary cortisol level

  Since cortisol shows circadian rhythm in premature infants, samples will be taken at the same time in the morning. Before taking saliva samples, the newborns mouth will be checked and oral care will be given with SF. Saliva samples will be collected with the Salimetrics Salivary Cortisol Kit by holding it in the cheek and sublingual cavity of the newborn for 1-2 minutes. The samples will be sent to the biochemistry laboratory of the research hospital. The samples will be analyzed for quantitative determination of cortisol by 2 biochemistry experts using standard procedures in the Biochemistry laboratory of TNKU Hospital. Samples will be taken twice, both during the procedure and 25 minutes after the procedure (the highest cortisol level after pain in newborns is detected between 20-30 minutes after the procedure).

  Through study completion, an average of 1 year

Study Arms (4)

pacifier with breast milk group

EXPERIMENTAL

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

Other: pacifier with breast milk

heel heating group

EXPERIMENTAL

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

Other: heel heating

combined intervention group

EXPERIMENTAL

all interventions combined (swaddling in the mother's lap together with giving a pacifier dipped in breast milk and heel heating

Other: interventions combined

Control

OTHER

swaddling the baby in the mother's lap

Other: Control

Interventions

pacifier with breast milk OTHER

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

pacifier with breast milk group

heel heating OTHER

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

heel heating group

interventions combined OTHER

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

combined intervention group

Control OTHER

swaddling the baby in the mother\'s lap

Control

Eligibility Criteria

• Age: 34 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Mother\'s voluntary participation in the study
• Preterm babies between 34 0/7-36 6/7 weeks
• Prematurity at 34 0/7-36 6/7 weeks and weight appropriate for the week (Appropriate Gestational Age- AGA),
• The baby should be fed at least 1 hour in advance.
• It has been 1 hour since the last painful intervention on the baby.
• Heel blood should be taken 6 hours after taking analgesic, sedative and anticonvulsant medications.

You may not qualify if:

• The baby has a fever
• The baby receiving oxygen therapy,
• The baby receiving antibiotic treatment
• The baby has a congenital anomaly
• The baby having the bed side and heater underneath
• The baby receiving phototherapy,
• The baby is connected to a mechanical ventilator
• Babies whose blood was not collected on the first attempt

Sponsors & Collaborators

• Namik Kemal University: lead

Related Publications (2)

• Shu SH, Lee YL, Hayter M, Wang RH. Efficacy of swaddling and heel warming on pain response to heel stick in neonates: a randomised control trial. J Clin Nurs. 2014 Nov;23(21-22):3107-14. doi: 10.1111/jocn.12549. Epub 2014 Jan 30.

  PMID: 24476226 RESULT

• Badiee Z, Nassiri Z, Armanian A. Cobedding of twin premature infants: calming effects on pain responses. Pediatr Neonatol. 2014 Aug;55(4):262-8. doi: 10.1016/j.pedneo.2013.11.008. Epub 2014 Mar 30.

  PMID: 24694748 RESULT

MeSH Terms

Conditions

Premature Birth; Pain

Interventions

Pacifiers; Milk, Human

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Infant Equipment; Equipment and Supplies; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Zeynem YILDIRIM BALKAN, Assist.Prof.

  Namik Kemal University

  STUDY DIRECTOR

• Birsen Mutlu, Assoc.Prof.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynem YILDIRIM BALKAN, Assist.Prof.

CONTACT

+905073190958; zyildirim@nku.edu.tr

Birsen Mutlu, Assoc.Prof.

CONTACT

+905326826862; bdonmez@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The same neonatal nurse with at least 5 years of experience will perform the interventions. Salivary cortisol sample will be taken by the same investigator with 5 years of experience. Salivary cortisol analysis will be performed in the laboratory by biochemistry specialists who have not seen the interventions performed on the newborn. Babies will be video recorded before, during and after the procedure. Video recordings will be monitored and recorded by 2 independent investigators. Data will be analyzed by an independent statistician other than the researchers.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Principal Investigator

Model Details: Application of 3 different interventions to reduce pain during heel prick blood collection in newborns and comparison with the control group. Control Group 1 (swaddling from mother\'s lap) Experiment Group 2 (swaddling from mother\'s lap + pacifier) Experiment Group 3 (swaddling from mother\'s lap + heel warming) Experiment Group 4 (swaddling from mother\'s lap + pacifier + heel warming)

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 4, 2024
• Study Start: November 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share