Venipuncture Clinical Trial
Official title:
Effects of Fetal Positioning on Pain and Physiological Parameters During Venipuncture in Preterm Neonates: A Randomized Controlled Trial
Verified date | December 2023 |
Source | Ankara Yildirim Beyazit University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Completed |
Enrollment | 60 |
Est. completion date | July 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Days to 28 Days |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Evrim KIZILER | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara Yildirim Beyazit University |
Turkey,
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.0000210 — View 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 — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Before the procedure, immediately after needle insertion, five minutes after needle removal. | |
Primary | Heart rate | The newborn's heart rate was monitored with a neonatal monitor and recorded on the monitoring form. | Before the procedure, immediately after needle insertion, five minutes after needle removal. | |
Primary | Oxygen saturation | The neonates' oxygen saturation was monitored with a neonatal monitor and recorded on the monitoring form. | Before the procedure, immediately after needle insertion, five minutes after needle removal. | |
Primary | Body temperature | The neonates' body temperature was monitored with a neonatal monitor and recorded on the monitoring form. | Before the procedure, immediately after needle insertion, five minutes after needle removal. | |
Secondary | Crying duration | The newborn's crying duration was recorded by the researcher (observer) using a chronometer. | Before the procedure, immediately after needle insertion, five minutes after needle removal. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05374902 -
Efficacy of Animation, Buzzy, and Multiple Interventions on Pain in Children
|
N/A | |
Completed |
NCT03139045 -
Impact of VeinViewer® Vision to Guide Peripheral Venipuncture in Geriatrics
|
Phase 3 | |
Completed |
NCT03122574 -
The Effects of Aromatherapy on the Incidence and Severity of Acute Pain
|
N/A | |
Recruiting |
NCT05831605 -
Success Rate Comparison of Venipuncture in Children With and Without Near-infrared Light
|
N/A | |
Completed |
NCT03004456 -
Distraction for Reduction of Pain Associated With Venipuncture in the Pediatric Post-Transplant Population
|
N/A | |
Completed |
NCT05727631 -
The Effect of Mother's Gentle Human Touch Method on Preterm Pain and Mother's Anxiety Level During Venipuncture
|
N/A | |
Completed |
NCT04027218 -
Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture.
|
N/A | |
Recruiting |
NCT05878483 -
Autonomous Blood Drawing Optimization and Performance Testing
|
N/A | |
Recruiting |
NCT05404594 -
Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants
|
N/A | |
Completed |
NCT05441241 -
Leap Motion Controller for Pain During Venipuncture in Pediatrics
|
N/A | |
Completed |
NCT05077345 -
The Effects of Different Procedures on Pain Levels at Preterm and Term Infants in Neonatal Intensive Care Unit
|
||
Completed |
NCT04690257 -
Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture
|
N/A | |
Completed |
NCT05680649 -
Effect of Breathing Exercise During Peripheral Intravenous Catheter
|
N/A | |
Completed |
NCT00233844 -
Studying the Analgesic Mechanism of the "Cough-Trick"
|
Phase 2 | |
Completed |
NCT06077409 -
''The Effect of Skin-to-Skin Contact and Gentle Touch Method Applied During Blood Collection on Early Detection of Pain and Physiological Parameters''
|
N/A | |
Completed |
NCT03899766 -
Support Activities for the Reduction of Distress and Pain in Children During Venipuncture
|
||
Not yet recruiting |
NCT04983303 -
Comparison of the Effectiveness of Distraction
|
N/A | |
Completed |
NCT01115062 -
Comparison of Synera Patch Versus LMX-4 Cream Versus Placebo Patch for Pain Reduction During Venipuncture in Children
|
Phase 2 | |
Completed |
NCT04346732 -
Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors
|
N/A |