Non-Nutritive Sucking vs Non-Nutritive Sucking Combined With Breast Milk on the Neonatal Comfort

Not Applicable

Completed

• Conditions: Infant, Premature
• Interventions: Procedure: Only NNS; Procedure: NNS Combined with Breast Milk

• Registration Number: NCT05097495
• Lead Sponsor: Acibadem University

Brief Summary

The aim of the study is to determine the effect of the use of non-nutritive sucking vs non-nutritive sucking combined with breast milk on neonatal comfort during diaper change in preterm infants.

Detailed Description

Newborns are faced with many painful interventions including tactile stimulation such as diaper change, axillary temperature measurement, intraoral and endotracheal aspiration during the postnatal period in the Neonatal Intensive Care Units (NICU) at the beginning of their lives. Painful interventions negatively affect the physiological parameters, comfort, sleep, growth and hospital stay of newborns. As a result of these interventions, the stress level increases in preterm infants. Increased stress level can cause long-term sequelae, risk of intraventricular hemorrhage, increased oxygen consumption and hypertension. In addition, the increased stress experience may make the infant sensitive to pain and stress in other periods of his life.

This randomized controlled prospective study was planned to be conducted in the NICU of a private hospital with branches in Istanbul until the whole sample group would be reached.

In the NICU, where the study will be conducted, preterm infants will be divided into two groups as control and experimental groups. Non-nutritive sucking (NNS) combined with breast milk will be used during diaper change for newborns in the experimental group, and only NNS will be used in the control group. NNS will be given to both groups 5 minutes before diaper change. The comfort level of the newborns will be measured with the Premature Infant Comfort Scale before the NNS, 5 minutes after the NNS, during the procedure, immediately after the procedure and 5 minutes after the procedure.

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-10-28
• Study Start: 2021-11-01
• Primary Completion: 2022-06-23
• Study Completion: 2022-06-23
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• The preterm infants whose parents agree to participate in the research and sign the informed consent form;
• Who have no congenital anomaly;
• Who have no chronic disease;
• Who have undergone no surgical procedure;
• Who have no neurological symptoms;
• Who have no NEC (necrotizing enterocolitis) diagnosis;
• Who are not sedated;
• Who are not hypoglycemic;
• Who have been administered no pharmacological analgesic method 4 hours before;
• Who are born between ≥28 and ≤36+6 gestation weeks, or are in between ≥28 and ≤36+6 gestation weeks during the procedure.

Exclusion Criteria

• The infants whose parents do not agree to participate in the research and do not sign the informed consent form;
• Who have a congenital anomaly;
• Who have a chronic disease;
• Who had undergone a surgical procedure;
• Who have neurological symptoms;
• Who have NEC (necrotizing enterocolitis) diagnosis;
• Who are sedated;
• Who are hypoglycemic;
• Who have been administered no pharmacological analgesic method 4 hours prior;
• Who were between <28 and >36+6 gestation weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (Only NNS)	Only NNS	NNS will be started 5 minutes before diaper change. The use of NNS will continue during diaper change and up to 5 minutes after the application.
Experimental Group (NNS Combined with Breast Milk)	NNS Combined with Breast Milk	NNS combined with breast milk will be started 5 minutes before diaper change. The use of NNS combined with breast milk will continue during diaper change and up to 5 minutes after the application.

Primary Outcome Measures

Name	Time	Method
Change in Comfort Level	5 minutes before, immediately before, during, immediately after, and 5 minutes after the procedure.The change in these time intervals will be assessed.	Infant's comfort level is evaluated with Premature Infant Comfort Scale.Premature Infant Comfort Scale (PICS), which is a multidimensional scale used in evaluating comfort and pain behaviorally and psychologically. The lowest score obtained from the scale is 35, and the highest score is 7. A high score on the scale indicates a low level of comfort.

Trial Locations

Locations (1)

Şişli Kolan International Hastanesi; 🇹🇷 İstanbul, Şişli, Turkey