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Peripheral Intravenous Central Catheter Intervention in Preterm Infants

The Effect of Grasping Palmar Reflex on Pain and Stress in Peripheral Intravenous Central Catheter Intervention in Preterm Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05359809
Enrollment
40
Registered
2022-05-04
Start date
2022-05-01
Completion date
2022-10-30
Last updated
2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nursing Caries, Pain, Acute, Preterm, Stress

Keywords

Preterm, Pain, Acute, Stress, Nursing Caries

Brief summary

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.

Detailed description

The study was planned in a parallel randomized controlled trial design. The population of the research will be preterm infants followed in the Newborn Intensive Care Unit of Atatürk University Health Research and Application Center between May 2022 and September 2022. Randomization in the sample of the study will be done in the computer environment. Sample size was determined by power analysis. In the collection of data; Preterm Baby Information Form, Preterm Baby Follow-up Form, Neonatal Stress Scale and ALPS-NEO pain and stress assessment scale will be used. In the control group, the PIC intervention will be performed by the investigator in accordance with clinical procedures. In the experimental group, the baby's grasping reflex stimulation will be provided during the PIC attempt.

Interventions

BEHAVIORALGraspin Palmar Reflex Stimulation

The grasping reflex is an involuntary response involving the hands and fingers. flexion-adduction movement. The reflex resembles the grasping movement of the hand. The reflex can be achieved by moving an object distally across the palm.

Sponsors

MSc İknur Budancamanak
CollaboratorUNKNOWN
Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
26 Weeks to 32 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Level12 weekNeonatal 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.
Stress Levell12 weekNeonatal 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026