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Preterm NeonatesNCT06173622

Effects of Fetal Positioning During Venipuncture

A study testing Fetal Positioning in people with Preterm Neonates and Venipuncture, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 6 to 28 days
Conditions the study is for
Preterm Neonates, Venipuncture
What is being tested?
Fetal Positioning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2021to 1 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Evrim KIZILER

    Ankara

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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?
Read the 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.

Being tested
Fetal Positioning
Keywords
Preterm neonates, Venipuncture, Fetal positioning, Pain, Physiological parameters, Nursing
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fetal PositioningBehavioural

    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).

Study groups in NCT06173622
Study groupRoleWhat they receive
Fetal positioning groupExperimentalThe 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.
Receives: Behavioral: Fetal Positioning
Control groupNo interventionNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Heart rate

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

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

  3. Oxygen saturation

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

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

  4. Body temperature

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

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

Secondary outcomes (1)

  1. Crying duration

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2023
  2. Study start1 Sep 2021
  3. Primary completion1 Jan 2022
  4. Study completion1 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06173622
Sponsor's protocol ID
EKIZILER-001
Status last verified
Dec 2023
First submitted
25 Nov 2023
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25060423

  • 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.

    PubMed 17057556

  • 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.

    PubMed 22001561

Questions about this trial

What is this clinical trial studying?

A study testing Fetal Positioning in people with Preterm Neonates and Venipuncture, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score (time frame: Before the procedure, immediately after needle insertion, five minutes after needle removal.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06173622, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.

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