Effects of Fetal Positioning During Venipuncture

Ankara Yildirim Beyazıt University

Status: Completed

Conditions: Preterm Neonates; Venipuncture

Treatments: Behavioral: Fetal Positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT06173622

EKIZILER-001

Details and patient eligibility

About

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?

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 6 to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Fetal positioning group

Experimental group

Description:

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.

Treatment:

Behavioral: Fetal Positioning

Control group

No Intervention group

Description:

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.