Effects of Fetal Positioning During Venipuncture

Venipuncture Clinical Trial

Official title:

Effects of Fetal Positioning on Pain and Physiological Parameters During Venipuncture in Preterm Neonates: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06173622
• Other study ID #: EKIZILER-001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2023
• Source: Ankara Yildirim Beyazit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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: 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?

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Days to 28 Days

Eligibility

Inclusion Criteria:

• Premature newborns (a) whose parents volunteered to participate in the study, (b) required venipuncture, and (c) were born at 26-32 gestational weeks were included in the study.

Exclusion Criteria:

• Newborns who are hypotonic, lethargic, in shock or having seizures,
• 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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Neonates
• Venipuncture

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
Turkey	Evrim KIZILER	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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.0000210 — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Secondary	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.