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Peripheral Intravenous Central Catheter Intervention in Preterm Infants

Primary Purpose

Preterm, Pain, Acute, Stress

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Graspin Palmar Reflex Stimulation
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm focused on measuring Preterm, Pain, Acute, Stress, Nursing Caries

Eligibility Criteria

26 Weeks - 32 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Grasping Palmar Reflex

Control

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 29, 2022
Last Updated
January 3, 2023
Sponsor
Ataturk University
Collaborators
MSc İknur Budancamanak
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1. Study Identification

Unique Protocol Identification Number
NCT05359809
Brief Title
Peripheral Intravenous Central Catheter Intervention in Preterm Infants
Official Title
The Effect of Grasping Palmar Reflex on Pain and Stress in Peripheral Intravenous Central Catheter Intervention in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
Collaborators
MSc İknur Budancamanak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm, Pain, Acute, Stress, Nursing Caries
Keywords
Preterm, Pain, Acute, Stress, Nursing Caries

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grasping Palmar Reflex
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Graspin Palmar Reflex Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Level
Description
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.
Time Frame
12 week
Title
Stress Levell
Description
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.
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ataturk University
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Peripheral Intravenous Central Catheter Intervention in Preterm Infants

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