Comparison Three Methods on Endotracheal Aspiration in Preterm Infants
Primary Purpose
Preterm, Pain, Acute, Physiological Stress
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Facilitated Tucking
Swaddling
Prone Position
Sponsored by
About this trial
This is an interventional supportive care trial for Preterm
Eligibility Criteria
Inclusion Criteria:
- Having 28-35 weeks of gestation,
- Follow-up as intubated in SIMV mode on mechanical ventilator,
- Follow-up on a ventilator between 1-10 days,
- Having a body weight of ≥1000 g,
- Those who have not taken any opioid or sedative medication until 4 hours before the procedure will be included.
Exclusion Criteria:
- Presence of congenital anomaly,
- Chest tube inserted
- Intracranial bleeding,
- Presence of condition/anomaly that will prevent prone tilting,
- Those with a history of epileptic seizures will be excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Facilitated Tucking
Swaddling
Prone position
control
Arm Description
giving facilitated tucking before, during and after the procedure
giving swaddling before, during and after the procedure
giving prone position before, during and after the procedure
Rutin care in the neonatal intensive care unit
Outcomes
Primary Outcome Measures
Pain scores
Premature infant pain profile-revised (PIPP-R) (min=0 max=21, the higher the score, the more severe the pain)
Comfort score
Newborn Comfort Behavior Scale (min=6 max=30, High scores signify that the infant is not comfortable)
physiological parameter (Heart rate)
physiological parameter (oxygen saturation)
Secondary Outcome Measures
Full Information
NCT ID
NCT05434364
First Posted
June 21, 2022
Last Updated
September 8, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT05434364
Brief Title
Comparison Three Methods on Endotracheal Aspiration in Preterm Infants
Official Title
Comparison the Effects of Facilitated Tucking, Swaddling and Prone Position Applied During Endotracheal Aspiration on Pain, Comfort and Physiological Parameters in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 21, 2023 (Anticipated)
Primary Completion Date
September 21, 2023 (Anticipated)
Study Completion Date
September 21, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Stress and pain control are vital for newborns, especially preterm babies. While painful procedures cause physiological changes in the short term, they negatively affect brain development in the long term. Non-pharmacological interventions with proven efficacy include: fetal position, sucrose, breastfeeding, breast milk, maternal presence, non-nutritive sucking, swaddling (wrapping) and skin-to-skin contact, as well as developmentally supportive positioning. Evaluating the effectiveness of nursing practices to be performed on babies, scientifically proving the most beneficial application that will both alleviate pain and increase their comfort in painful procedures such as aspiration and being more beneficial to babies are among the most basic benefits. Thanks to these applications, it is predicted that your baby will experience less pain and provide more comfort. Therefore, this study aim to comparison the effects of facilitated tucking, swaddling and prone position applied during endotracheal aspiration on pain, comfort and physiological parameters in preterm infants.
Detailed Description
The universe of the research; between July-September 2022, patients who are intubated on a mechanical ventilator at 32-36 weeks of gestation (middle preterm group) in Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital Neonatal Intensive Care Unit will consist of. In order to determine the sample size of the study, power analysis was performed using the G*Power (V3.1.9.7) program. According to Cohen's effect size coefficients; Assuming that the effect size (f = 0.4) of the evaluations to be made between four independent groups will be large/large, Taplak and Bayat (2021) found the effect size as 0.932 as a result of the Power analysis based on the PIPP-R results. In this study, it was determined that there should be at least 15 people in all groups (Fetal position, Swaddling, Prone position and control group) according to the new calculation made with 0.932 effect size, 5% alpha (two-sided) and 99% power. Considering that there may be losses during the study, each group will form a sample of 100 infants, 25 infants each. Random assignment of babies to groups will be carried out by the researcher through a computer program (https://www.randomizer.org)/. After determining the groups of premature babies randomly, one group will be given fetal position, one group swaddling position and one group prone position before, during and after endotracheal aspiration. Pain scores (PIPP-R), comfort scores (Comfort Scale) and physiological parameters (Heart peak beat, oxygen saturation value measured by pulse oximetry) 3 minutes before, during and after these nursing practices in the 1st and 3rd minutes after the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm, Pain, Acute, Physiological Stress, Nursing Care, Comfort
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Facilitated Tucking
Arm Type
Experimental
Arm Description
giving facilitated tucking before, during and after the procedure
Arm Title
Swaddling
Arm Type
Experimental
Arm Description
giving swaddling before, during and after the procedure
Arm Title
Prone position
Arm Type
Experimental
Arm Description
giving prone position before, during and after the procedure
Arm Title
control
Arm Type
No Intervention
Arm Description
Rutin care in the neonatal intensive care unit
Intervention Type
Other
Intervention Name(s)
Facilitated Tucking
Intervention Description
giving facilitated tucking before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
Intervention Type
Other
Intervention Name(s)
Swaddling
Intervention Description
swaddling before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
Intervention Type
Other
Intervention Name(s)
Prone Position
Intervention Description
giving prone position before (1st and 3th minutes), during and after (1st and 3th minutes) the procedure
Primary Outcome Measure Information:
Title
Pain scores
Description
Premature infant pain profile-revised (PIPP-R) (min=0 max=21, the higher the score, the more severe the pain)
Time Frame
6 minutes
Title
Comfort score
Description
Newborn Comfort Behavior Scale (min=6 max=30, High scores signify that the infant is not comfortable)
Time Frame
6 minutes
Title
physiological parameter (Heart rate)
Time Frame
6 minutes
Title
physiological parameter (oxygen saturation)
Time Frame
6 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having 28-35 weeks of gestation,
Follow-up as intubated in SIMV mode on mechanical ventilator,
Follow-up on a ventilator between 1-10 days,
Having a body weight of ≥1000 g,
Those who have not taken any opioid or sedative medication until 4 hours before the procedure will be included.
Exclusion Criteria:
Presence of congenital anomaly,
Chest tube inserted
Intracranial bleeding,
Presence of condition/anomaly that will prevent prone tilting,
Those with a history of epileptic seizures will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serap Ozdemir, PhD
Phone
+905375438610
Email
serap8685@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31229348
Citation
Taplak AS, Bayat M. Psychometric Testing of the Turkish Version of the Premature Infant Pain Profile Revised-PIPP-R. J Pediatr Nurs. 2019 Sep-Oct;48:e49-e55. doi: 10.1016/j.pedn.2019.06.007. Epub 2019 Jun 19.
Results Reference
result
PubMed Identifier
26002861
Citation
Hartley KA, Miller CS, Gephart SM. Facilitated tucking to reduce pain in neonates: evidence for best practice. Adv Neonatal Care. 2015 Jun;15(3):201-8. doi: 10.1097/ANC.0000000000000193.
Results Reference
result
PubMed Identifier
25060423
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.
Results Reference
result
Learn more about this trial
Comparison Three Methods on Endotracheal Aspiration in Preterm Infants
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