Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-09-01
2022-07-01
Brief Summary
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This randomized controlled clinical trial was conducted between 10.2021-07.2022 with 60 preterm neonates, aged 26-32 week of gestation. Neonates were divided into intervention group (n=30) and control group (n=30) according to the randomization method. The neonates in the intervention group were put into fetal positioning at least 10 minutes before the procedure, and then venipuncture was performed. The fetal positioning was maintained throughout the procedure and the patient was kept in the fetal position for at least five more minutes after the procedure. Changes in the neonates' pain score and crying duration as well as heart rate, blood temperature, blood-oxygen saturation at three time points: before the procedure, immediately after needle insertion, five minutes after needle removal. Data was collected using the sociodemographic form, neonatal observation form and Neonatal Pain, Agitation and Sedation Scale (N-PASS). The collected data were analyzed using the SPSS 15 software.
The main questions it aims to answer:
1. Does fetal positioning have an effect on pain score of premature neonates?
2. Does fetal positioning have an effect on heart rate of preterm neonates?
3. Does fetal positioning have an effect on oxygen saturation of preterm neonates?
4. Does fetal positioning have an effect on body temperature of the preterm neonates?
5. Does fetal positioning have an effect on the crying duration of preterm neonates?
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Fetal positioning group
The neonates in the experimental group were put into fetal positioning at least 10 minutes before the procedure, and then venipuncture was performed. The fetal positioning was maintained throughout the procedure and the patient was kept in the fetal position for at least five more minutes after needle removal.
Fetal Positioning
In the study, venipuncture was applied to the intervention and control groups. While the procedure was performed by an experienced neonatal nurse, the neonates' pain score, crying duration and physiological parameters were monitored by another researcher (observer).
Control group
No intervention was performed by the researchers on the neonates included in the control group, and venipuncture was performed in accordance with the standard procedure of the neonatal intensive care unit.
No interventions assigned to this group
Interventions
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Fetal Positioning
In the study, venipuncture was applied to the intervention and control groups. While the procedure was performed by an experienced neonatal nurse, the neonates' pain score, crying duration and physiological parameters were monitored by another researcher (observer).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Newborns with a history of stage 3-4 intracranial hemorrhage
* Newborns with a history of surgery
* Newborns whose gestational week is over 37 weeks
* Newborns who have taken any analgesics and/or sedatives in the last 24 hours,
* Newborns who have had any invasive procedure within the last hour
* Newborns whose parents do not volunteer
6 Days
28 Days
ALL
No
Sponsors
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Ankara Yildirim Beyazıt University
OTHER
Responsible Party
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Evrim Kızıler
Assistant Professor
Principal Investigators
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Evrim KIZILER, PhD
Role: PRINCIPAL_INVESTIGATOR
Ankara Yildirim Beyazıt University
Locations
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Evrim KIZILER
Ankara, , Turkey (Türkiye)
Countries
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References
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Lopez O, Subramanian P, Rahmat N, Theam LC, Chinna K, Rosli R. The effect of facilitated tucking on procedural pain control among premature babies. J Clin Nurs. 2015 Jan;24(1-2):183-91. doi: 10.1111/jocn.12657. Epub 2014 Jul 24.
Holsti L, Grunau RE, Whifield MF, Oberlander TF, Lindh V. Behavioral responses to pain are heightened after clustered care in preterm infants born between 30 and 32 weeks gestational age. Clin J Pain. 2006 Nov-Dec;22(9):757-64. doi: 10.1097/01.ajp.0000210921.10912.47.
Liaw JJ, Yang L, Katherine Wang KW, Chen CM, Chang YC, Yin T. Non-nutritive sucking and facilitated tucking relieve preterm infant pain during heel-stick procedures: a prospective, randomised controlled crossover trial. Int J Nurs Stud. 2012 Mar;49(3):300-9. doi: 10.1016/j.ijnurstu.2011.09.017. Epub 2011 Oct 14.
Other Identifiers
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EKIZILER-001
Identifier Type: -
Identifier Source: org_study_id