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The study was aimed to examine the effects of fetal positioning during venipuncture on the neonates' pain score and physiological parameters (heart rate, blood-oxygen saturation, body temperature, crying duration) in neonatal intensive care unit (NICU).
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:
Neonates who were hypotonic, lethargic, in shock or had seizures, stage 3-4 intracranial hemorrhage and a history of surgery were not included in the study. Additionally, neonates was taken any analgesic and/or sedative in the last 24 hours were excluded from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fetal positioning group | Experimental | 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. |
|
| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fetal Positioning | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Neonatal Pain Agitation and Sedation Scale (N-PASS) is a multidimensional scale that scores 5 behavioral and physiologic parameters for both pain and sedation. It is proficient in assessing continuous, acute, and chronic pain. In the scale crying/irritability, behavior state, facial expression, ekstremites tone and vital signs of newborns are scored between 0-2 points and the total score is obtained. A minimum of 0 and a maximum of 10 points are obtained from the scale, and an increase in score indicates an increase in pain. A score of four and below reflects mild pain, and a score of five and above reflects moderate and severe pain. | Before the procedure, immediately after needle insertion, five minutes after needle removal. |
| Heart rate | The newborn's heart rate was monitored with a neonatal monitor and recorded on the monitoring form. | Before the procedure, immediately after needle insertion, five minutes after needle removal. |
| Oxygen saturation | The neonates' oxygen saturation was monitored with a neonatal monitor and recorded on the monitoring form. | Before the procedure, immediately after needle insertion, five minutes after needle removal. |
| Body temperature | The neonates' body temperature was monitored with a neonatal monitor and recorded on the monitoring form. | Before the procedure, immediately after needle insertion, five minutes after needle removal. |
| Measure | Description | Time Frame |
|---|---|---|
| Crying duration | The newborn's crying duration was recorded by the researcher (observer) using a chronometer. | Before the procedure, immediately after needle insertion, five minutes after needle removal. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evrim KIZILER, PhD | Ankara Yildirim Beyazıt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evrim KIZILER | Ankara | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25060423 | Result | 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. | |
| 17057556 | Result | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 22001561 | Result | 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. |