Effects of Fetal Positioning During Venipuncture

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

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?

Study Overview

• Status: Completed
• Conditions: Preterm Neonates; Venipuncture
• Intervention / Treatment: Behavioral: Fetal Positioning

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Evrim KIZILER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University
• Investigators: Principal Investigator: Evrim KIZILER, PhD, Ankara Yildirim Beyazıt University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: November 25, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Nursing; Venipuncture; Physiological parameters; Preterm neonates; Fetal positioning
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: EKIZILER-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No