Stress Clinical Trial
Official title:
The Effect of Grasping Palmar Reflex on Pain and Stress in Peripheral Intravenous Central Catheter Intervention in Preterm Infants
Verified date | January 2023 |
Source | Ataturk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will be conducted to evaluate the effect of grasping reflex stimulation applied during peripheral intravenous central catheter (PIC) intervention on pain and stress in preterm infants receiving treatment and care in the neonatal intensive care unit.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 26 Weeks to 32 Weeks |
Eligibility | Inclusion Criteria: - Between 26-32 weeks of gestation, - Birth weight of 1500 g and below, - No congenital defects - who need PIC intervention while receiving treatment and care in the NICU, - Not receiving sedation at least 3 hours before the PIC procedure, - No neurological problems - No surgical intervention - Recipient of noninvasive mechanical ventilation - infants whose parents approved the informed voluntary consent form Exclusion Criteria: - Painful procedure (invasive procedure, etc.) has been performed in the last hour, - Infants without parental informed consent form |
Country | Name | City | State |
---|---|---|---|
Turkey | Ataturk University | Erzurum |
Lead Sponsor | Collaborator |
---|---|
Ataturk University | MSc Iknur Budancamanak |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Level | Neonatal pain and stress rating scale: The scale was developed by Lundqvist et al. in 2014. It is used to measure pain and stress in preterm and term newborns. The scale is a five-item scale that includes the newborn's facial expression, breathing pattern, tone of the extremities, hand and foot activity, and activity level. The lowest score that can be obtained from the scale is 0 and the highest score is 10. As the scale score increases, it indicates that the level of pain and stress increases. | 12 week | |
Primary | Stress Levell | Neonatal stress scale: It was developed to evaluate stress in premature babies. The scale consists of eight items; facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, and posture. Scale It is a 3-point Likert type and is evaluated between 0-2 points in scoring. A minimum of 0 points from the scale, A maximum of 16 points is taken. As the score increases, the baby's stress level increases. | 12 week |
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