Fenerbahce University
Ataşehir, Istanbul, 34758, Turkey (Türkiye)
NCT Number: NCT06455631
The research will be conducted using a randomized controlled experimental method.The preterm newborns included in the study will be randomized into three groups using the sealed envelope method. In the facilitated tucking position + oral breast milk group, preterm newborns will be placed in the facilitated tucking position 15 minutes before tape removal and given oral breast milk 2 minutes before. This position will be maintained until 2 minutes after tape removal. Preterm newborns in the kangaroo care + oral breast milk group will undergo kangaroo care 15 minutes before tape removal and receive oral breast milk 2 minutes before. Kangaroo care allows mother-baby interaction but no feeding. In the control group, newborns will undergo routine nesting with gentle touch and verbal comfort provided if they cry.This study is designed to evaluate the effect of the fetal position, oral breast milk administration, and kangaroo care on pain during tape removal in preterm newborns.
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Notify Me30 week–36 week
All sexes
Interventional
Not applicable
Ataşehir, Istanbul, 34758, Turkey (Türkiye)
In the study, the groups of the babies will be determined by a lottery method. Preterm babies included in the study will be randomly assigned to three groups using a closed envelope method. To ensure equal distribution of babies according to gestational age, two sets of envelopes will be created for 30-33+6 weeks and 34-36+6 weeks. An independent nurse working in the NICU will be asked to select a paper from the closed envelope corresponding to the baby's gestational week. Based on the number written on the selected paper, the baby will be included in the study group. The groups will be: Group 1 - facilitated tucking position + oral breast milk, Group 2 - kangaroo care + oral breast milk, and Group 3 - control group. After the babies are assigned to the groups, data collection will begin.
Before data collection, the researcher will provide necessary information about the study to the families of the newborns who meet the sample selection criteria and will answer their questions. After obtaining written consent from the parents of the babies who agree to participate, they will be included in the study. The information in the introductory information form for the newborn and parents will be recorded by the researcher.
Interventions for the CONTROL Group Newborns in the control group will undergo the routine nesting procedure of the clinic. All newborns will be placed in the lateral position. For ethical reasons, if babies cry during or after the procedure, gentle touch and verbal comfort will be provided to them.
In all experimental groups, heart rate, respiratory rate, oxygen saturation values, and PIPP-R scores will be measured and recorded at the following time points:
The PIPP-R scores of all groups will be recorded on a data assessment form by two independent evaluators based on video recordings.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Before data collection, the researcher will inform families of newborns meeting the sample criteria about the study and obtain written consent from participating parents. Newborn and parent information will be recorded. Procedures will occur between 08:00 and 16:00, with one researcher, two nurses, and a preterm newborn present during tape removal. Tape removal will be done by the same nurse. Physiological and behavioral responses will be recorded before, during, and after tape removal. Breast milk will be orally administered during tape removal, with the amount adjusted based on gestational age. Measurements will be taken at specified time points, including heart rate, respiratory rate, oxygen saturation, and PIPP-R score. These procedures will also apply to the control group. PIPP-R scores will be recorded by two evaluators based on video recordings.
Time frame: Maximum 17 minutes
We will assess newborns' pain using the PIPP-R tool before the procedure and at 13, 15, and 17 minutes after starting the procedure.
Time frame: Maximum 17 minutes
In order to determine the infant's heart rate, a 'Covidien' pulse oximeter will be used. It will be recorded by the observing nurse in the observation form before the procedure and at 13, 15, and 17 minutes after starting the procedure.
Time frame: Maximum 17 minutes
In order to determine the infant's oxygen saturation, a 'Covidien' pulse oximeter will be used. It will be recorded by the observing nurse in the observation form before the procedure and at 13, 15, and 17 minutes after starting the procedure.
Time frame: Maximum 17 minutes
A Casio brand stopwatch will be used to count the respiratory rate of the preterm newborn.
Fenerbahce University
Other
The Effect of Facilitated Tucking, Oral Breast Milk, and Kangaroo Care on Pain During Band Removal in Preterm Newborns
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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