Skip to main content
OpenTrials
Completed

NCT Number: NCT06173622

Effects of Fetal Positioning During Venipuncture

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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preterm Neonates Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Venipuncture

Age range

6 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evrim KIZILER

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Pain score

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

    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.

  2. Heart rate

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

    The newborn's heart rate was monitored with a neonatal monitor and recorded on the monitoring form.

  3. Oxygen saturation

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

    The neonates' oxygen saturation was monitored with a neonatal monitor and recorded on the monitoring form.

  4. Body temperature

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

    The neonates' body temperature was monitored with a neonatal monitor and recorded on the monitoring form.

Secondary outcomes

  1. Crying duration

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

    The newborn's crying duration was recorded by the researcher (observer) using a chronometer.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 18, 2023
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.