Clinical trial NCT06173622: Effects of Fetal Positioning During Venipuncture
Official title: Effects of Fetal Positioning on Pain and Physiological Parameters During Venipuncture in Preterm Neonates: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Neonates
Venipuncture
Keywords: Preterm neonates
Venipuncture
Fetal positioning
Pain
Physiological parameters
Nursing
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score
timeFrame: Before the procedure, immediately after needle insertion, five minutes after needle removal.
measure: Heart rate
timeFrame: Before the procedure, immediately after needle insertion, five minutes after needle removal.
measure: Oxygen saturation
timeFrame: Before the procedure, immediately after needle insertion, five minutes after needle removal.
measure: Body temperature
timeFrame: Before the procedure, immediately after needle insertion, five minutes after needle removal.
Secondary outcomes:
measure: Crying duration
timeFrame: Before the procedure, immediately after needle insertion, five minutes after needle removal.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Evrim KIZILER
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Evrim KIZILER, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.