Effects of Fetal Positioning During Venipuncture

NCT06173622 | Completed

• 1 other identifier: EKIZILER-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does fetal positioning have an effect on pain score of premature neonates?
2. 2.Does fetal positioning have an effect on heart rate of preterm neonates?
3. 3.Does fetal positioning have an effect on oxygen saturation of preterm neonates?
4. 4.Does fetal positioning have an effect on body temperature of the preterm neonates?
5. 5.Does fetal positioning have an effect on the crying duration of preterm neonates?

Conditions

Preterm Neonates; Venipuncture

Keywords

Preterm neonates; Venipuncture; Fetal positioning; Pain; Physiological parameters; Nursing

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Crying duration

  Before the procedure, immediately after needle insertion, five minutes after needle removal.

Study Arms (2)

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.

Behavioral: Fetal Positioning

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.

Interventions

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).

Fetal positioning group

Eligibility Criteria

• Age: 6 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Evrim KIZILER

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 25060423 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.

  PMID: 17057556 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.

  PMID: 22001561 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Evrim KIZILER, PhD

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 25, 2023
• First Posted: December 18, 2023
• Study Start: September 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)