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The study will be conducted using the crossover randomized controlled method. Preterm infants who began oral feeding from the neonatal intensive care unit will be divided into two groups through randomization in the computer environment. Following the randomization, infants in Group 1 will be fed by applying ''elastic sac'' at the first feeding hour after they are included in the study and in the next feeding they will be fed without performing any application. Infants in Group 2 will be fed without performing any application at the first feeding hour after they are included in the study and they will be fed at the second feeding hour by applying ''elastic sac''. Infants in both groups will be fed by the researcher with a bottle in a semi-fowler right lateral position during feeding hours. During feeding, the effect of the elastic sac on the infant's feeding status and physiological parameters will be evaluated.
Swaddling method is a method which can be used for preserving thermoregulation, decreasing stress and maintaining comfort in term and preterm infants during painful procedures. The effect of the ''elastic sac'' method which is thought to imitate the uterus environment, on physiological parameters and feeding performance of infants during feeding will be evaluated. The ''elastic sac'' method will be applied with 100% cotton and elastic fabric. The single-use elastic and cotton fabric was sewed as a U-shaped sac for each infant included in the study. The infant will be placed in the sac during the feeding hour and will be placed in a position in which he/she can move easily, maintain the flexion posture and feel safe contrary to traditional swaddling. The purpose of the study is to evaluate stress-associated physiological parameters and feeding status during oral feeding in preterm infants starting oral feeding. The study will be conducted using the crossover randomized controlled method. The sample size of the study was determined via the power analysis in accordance with the results obtained from studies conducted via a similar research method. According to the results of the analyses, a total of 26 preterm infants including 13 for each group will be included in the study group. After informing the families of infants meeting the inclusion criteria both in written and oral forms, the study will be conducted with mothers who agree to participate in the study and their infants.
Application Stages GROUP 1
GROUP 2
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Half an hour before the first feeding hour, the infant's heart rate and oxygen saturation will be recorded. Then, he/she will be placed in the elastic sac, positioned and will be allowed to take a rest until the feeding hour for 30 minutes. His/her physiological parameters will be recorded ten minutes before the feeding time, during feeding and ten minutes after feeding. When the feeding time begins, the chronometer will be started and it will be stopped when feeding is completed. At the second feeding time, the infant's heart rate and oxygen saturation will be recorded half an hour before the feeding hour. Then, he/she will be positioned without performing any different application and will be allowed to take a rest until the feeding time. His/her physiological parameters will be recorded ten minutes before the feeding time, during feeding and ten minutes after feeding. When feeding begins, the chronometer will be started and when it is over, the chronometer will be stopped. |
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| Group 2 | Experimental | Half an hour before the first feeding time of the infant, his/her heart rate and oxygen saturation will be recorded. Then, he/she will be positioned without performing any different application and will be allowed to take a rest until the feeding time. His/her physiological parameters will be recorded ten minutes before the feeding hour, during feeding and ten minutes after feeding. When feeding begins, the chronometer will be started and when it is over, the chronometer will be stopped. At the second feeding hour, the infant's heart rate and oxygen saturation will be recorded half an hour before the feeding hour. Then, he/she will be placed in the elastic sac, positioned, and allowed to take a rest until the feeding hour. His/her physiological parameters will be recorded ten minutes before the feeding hour, during feeding and ten minutes after feeding. When feeding begins, the chronometer will be started and when it is over, the chronometer will be stopped. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elastic Sac | Other | Half an hour before the feeding time, the infant will be placed in the elastic sac, be laid in the right lateral position within the nest with an angle of 45 degrees and will be allowed to take a rest within the elastic sac for half an hour. At the feeding time, he/she will be fed by the researcher with a bottle in the right lateral position within the elastic sac with an angle of 45 degrees without making any change in his/her position. |
| Measure | Description | Time Frame |
|---|---|---|
| Feeding Status | In order to assess the feeding status of the infant, his/her time of feeding and the amount of nutrient he/she receives in a minute will be calculated. In order to determine his/her time of feeding, a phone chronometer will be started as soon as he/she begins feeding and it will be stopped when feeding is over. All infants in Group 1 and Group 2 will be fed with a slow-flow bottle branded Avent which is designed for premature infants. It will be calculated how much (cc) of the total amount of nutrient ordered by the doctor the infant receives. The total amount of nutrient received by the infant will be divided into the time of feeding and thus the amount of nutrient received in a minute (cc) will be calculated. | maximum 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | In order to determine the infant's heart rate, a 'Covidien' pulse oximeter will be used. It will be recorded by the observer nurse in the observation form every two minutes once half an hour before the feeding hour of all infants in Group 1 and Group 2, ten minutes before the feeding hour, throughout feeding and ten minutes after feeding. | All babies in Group 1 and Group 2 will be recorded in the registration form by the observing nurse once half an hour before the feeding time, 10 minutes before the feeding time, during the feeding and at 2-minute intervals 10 minutes after the feeding. |
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Criteria Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Duygu GÖZEN, Prof. | Istanbul University - Cerrahpasa | Principal Investigator |
| Fatma Narter Kaya, Assoc. Prof. | Istanbul Dr. Lütfi Kırdar Şehir Hastanesi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University, Cerrahpaşa | Istanbul | Turkey (Türkiye) |
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| Control | Other | Half an hour before the feeding time, the infant will be laid in the right lateral position within the nest with an angle of 45 degrees without performing any different application and will be allowed to take a rest. At the feeding time, he/she will be fed by the researcher with a bottle in the right lateral position within the elastic sac with an angle of 45 degrees without making any change in his/her position. |
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| Oxygen Saturation | In order to determine the infant's oxygen saturation, a 'Covidien' pulse oximeter will be used. It will be recorded by the observer nurse in the observation form every two minutes once half an hour before the feeding time of all infants in Group 1 and Group 2, ten minutes before the feeding hour, throughout feeding and ten minutes after feeding. | All babies in Group 1 and Group 2 will be recorded in the registration form by the observing nurse once half an hour before the feeding time, 10 minutes before the feeding time, during the feeding and at 2 minutes intervals 10 minutes after the feeding. |