Effects of Fetal Positioning During Venipuncture

Not Applicable

Completed

• Conditions: Preterm Neonates; Venipuncture
• Interventions: Behavioral: Fetal Positioning

• Registration Number: NCT06173622
• Lead Sponsor: Ankara Yildirim Beyazıt University

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. 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?

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 Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-07-01
• Study First Submitted: 2023-11-25
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Study First Posted: 2023-12-18
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fetal positioning group	Fetal Positioning	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.

Primary Outcome Measures

Name	Time	Method
Pain score	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.
Oxygen saturation	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.
Heart rate	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.
Body temperature	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 Outcome Measures

Name	Time	Method
Crying duration	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.

Trial Locations

Locations (1)

Evrim KIZILER; 🇹🇷 Ankara, Turkey