search
Back to results

Pain and Comfort During Endotracheal Suction in Premature Neonates

Primary Purpose

Premature

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Swaddling
Oropharyngeal colostrum
Sponsored by
Istanbul Aydın University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature focused on measuring endotracheal suction, pain, comfort, swaddling, colostrum

Eligibility Criteria

1 Day - 5 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The gestational age of the baby is 26-36 weeks according to the mother's last menstrual period
  • Baby's postnatal 0-5. be between days
  • Receiving invasive mechanical ventilation support
  • No analgesic, opioid and sedative pain relievers were administered in the 4 hours before the procedure.
  • It has been 2 hours since the last painful attempt.
  • Parental consent of the premature baby.
  • Applying endotracheal suction at most 2 times since birth

Exclusion Criteria:

  • Presence of congenital anomaly
  • Having a history of convulsions
  • Any extremity fracture/dislocation that will prevent wrapping
  • Having a pneumothorax tube

Sites / Locations

  • Istanbul Aydin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

The control group

The swaddling group

The oropharyngeal colostrum group

Arm Description

• In addition to incubator cover and nesting, no other non-pharmacological intervention was applied to the control group.

•Babies in this group were wrapped with a white cheesecloth 2 minutes before ES in addition to incubator cover and nesting.

• In addition to incubator cover and nesting, babies in this group were given 0.4 ml of colostrum with an insulin injector on the inside of the cheeks and on the tongue.

Outcomes

Primary Outcome Measures

Change in Heart Rate
Heart rate will be monitored
Change in Oxygen Saturation
Oxygen saturation will be monitored
Change in pain score
Pain score will be evaluated with Premature Infant Pain Profile-Revised (PIPP-R).
Change in comfort score
Comfort score will be evaluated with Newborn Comfort Behavior Scale (COMFORTneo)

Secondary Outcome Measures

Change in Respiratory Rate
Respiratory Rate will be monitored
Change in Body temperature
Body temperature will be measurement
Change in blood pressure
Blood pressure will be monitored

Full Information

First Posted
September 10, 2021
Last Updated
October 15, 2021
Sponsor
Istanbul Aydın University
search

1. Study Identification

Unique Protocol Identification Number
NCT05095285
Brief Title
Pain and Comfort During Endotracheal Suction in Premature Neonates
Official Title
The Effect of Swaddling and Oropharyngeal Colostrum During Endotracheal Suctioning on Procedural Pain and Comfort in Premature Neonates.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Aydın University

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
Most of the preterm babies in neonatal units are followed up with invasive mechanical ventilation support. For this reason, endotracheal suction is needed repeatedly in preterm babies in order to open the airway obstruction caused by secretions and to maintain the airway patency. Endotracheal aspiration, which is one of the invasive procedures in which pain is felt most in newborns, is performed by nurses. Endotracheal suction, which causes pain and discomfort in intensive care units, negatively affects the comfort of patients. Studies emphasize that comfort is an indicator of pain and stress, and the comfort scale is also used in pain and distress assessments. Effective pain management and the development of pain-related care standards to reduce pain in preterm newborn infants improve clinical and neurodevelopmental outcomes. For this reason, it is necessary to reduce the pain that has an effect on the development of preterm babies. In pediatric nursing, studies on non-pharmacological methods have increased in recent years in order to increase the comfort of infants and reduce pain and stress, especially during painful and stressful procedures in infants followed in neonatal intensive care units. When the literature is examined, there are few studies measuring the effectiveness of non-pharmacological methods used in reducing pain due to endotracheal suction. There are differences in the effectiveness of the methods applied in the existing studies. Therefore, more observation, research and scientific studies by neonatal nurses are needed to reduce the pain associated with endotracheal suction in preterm newborns. In this study, swaddling and oropharyngeal colostrum, which are two non-pharmacological methods, will be applied during endotracheal suction to preterm newborns receiving invasive mechanical ventilation support. This experimental study was planned to determine the effect of these two non-pharmacological methods on procedural pain and comfort and to contribute to evidence-based nursing practices.
Detailed Description
The study was conducted experimentally in randomized controlled trials to determine the effect of two non-pharmacological methods, swaddling and oropharyngeal colostrum on procedural pain and comfort during endotracheal suction (ES) in premature neonates. The population of the study was intubated premature neonates hospitalized in NICU in two foundation university hospitals between July 2019 and October 2020. The study sample consisted of 48 babies who met the sample selection criteria. Descriptive Characteristics Form, Premature Infant Intervention Follow-up Form, Premature Infant Pain Profile-Revised (PIPP-R) and Newborn Comfort Behavior Scale (COMFORTneo) were used in data collection. Two minutes before the ES procedure, babies were swaddled or 0.4 ml of oropharyngeal colostrum was given, depending on the group in which they were involved. Physiological parameters (heart rate, respiration, saturation) of the babies were recorded before, during and after the procedure, and PIPP-R and COMFORTneo scores were given by two observers by video recording.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature
Keywords
endotracheal suction, pain, comfort, swaddling, colostrum

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The control group
Arm Type
No Intervention
Arm Description
• In addition to incubator cover and nesting, no other non-pharmacological intervention was applied to the control group.
Arm Title
The swaddling group
Arm Type
Experimental
Arm Description
•Babies in this group were wrapped with a white cheesecloth 2 minutes before ES in addition to incubator cover and nesting.
Arm Title
The oropharyngeal colostrum group
Arm Type
Experimental
Arm Description
• In addition to incubator cover and nesting, babies in this group were given 0.4 ml of colostrum with an insulin injector on the inside of the cheeks and on the tongue.
Intervention Type
Other
Intervention Name(s)
Swaddling
Intervention Description
Babies in this group were wrapped with a white cheesecloth 2 minutes before ES in addition to incubator cover and nesting. Common procedure steps: Legal representatives of the infants will sign an informed consent form. İncubator cover and nesting Endotracheal suction(ES) was performed in the supine position. ES was done at the time of care the baby needed. No painful procedure was applied until 2 hours before ES and 15 minutes after ES. Aspiration was performed sterile at 80 mmHg pressure. A second nurse assisted in the suction process and the procedure took no more than 15 seconds. The amount of oxygen taken by the baby was increased by 10% 30 seconds before the suction procedure and returned to its original value 60 seconds after the procedure. Beginning 3 minutes before the ES procedure, during the procedure and until 15 minutes after the procedure, the infants' behaviors and bedside monitor indicators were video recorded.
Intervention Type
Other
Intervention Name(s)
Oropharyngeal colostrum
Intervention Description
Common procedure steps In addition to incubator cover and nesting, babies in this group were given 0.4 ml of colostrum with an insulin injector on the inside of the cheeks and on the tongue.
Primary Outcome Measure Information:
Title
Change in Heart Rate
Description
Heart rate will be monitored
Time Frame
Baby's heart rate will monitored during 20 minutes since it will start the camera record. (Heart rates will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Title
Change in Oxygen Saturation
Description
Oxygen saturation will be monitored
Time Frame
Baby's oxygen saturation will monitored during 20 minutes since it will start the camera record. (Oxygen Saturation will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Title
Change in pain score
Description
Pain score will be evaluated with Premature Infant Pain Profile-Revised (PIPP-R).
Time Frame
Baby's pain score will be evaluated during 20 minutes since it will start the camera record. (Pain score will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Title
Change in comfort score
Description
Comfort score will be evaluated with Newborn Comfort Behavior Scale (COMFORTneo)
Time Frame
Baby's comfort score will be evaluated during 20 minutes since it will start the camera record. (Comfort score will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)
Secondary Outcome Measure Information:
Title
Change in Respiratory Rate
Description
Respiratory Rate will be monitored
Time Frame
Baby's respiratory rate will be monitored during 20 minutes since it will start the camera record. (Respiratory Rate will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES; 5, 10 and 15 minutes later.)
Title
Change in Body temperature
Description
Body temperature will be measurement
Time Frame
Baby's body temperature will be measurement during 20 minutes since it will start the camera record. (Body temperature will be measurement at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES; 5, 10 and 15 minutes later.)
Title
Change in blood pressure
Description
Blood pressure will be monitored
Time Frame
Baby's blood pressure will be monitored during 20 minutes since it will start the camera record. (Blood pressure will be monitored at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
5 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The gestational age of the baby is 26-36 weeks according to the mother's last menstrual period Baby's postnatal 0-5. be between days Receiving invasive mechanical ventilation support No analgesic, opioid and sedative pain relievers were administered in the 4 hours before the procedure. It has been 2 hours since the last painful attempt. Parental consent of the premature baby. Applying endotracheal suction at most 2 times since birth Exclusion Criteria: Presence of congenital anomaly Having a history of convulsions Any extremity fracture/dislocation that will prevent wrapping Having a pneumothorax tube
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birsen Mutlu, Ass. Prof.
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Aydin University
City
Istanbul
ZIP/Postal Code
34295
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
29123341
Citation
Desai S, Nanavati RN, Nathani R, Kabra N. Effect of Expressed Breast Milk versus Swaddling versus Oral Sucrose Administration on Pain Associated with Suctioning in Preterm Neonates on Assisted Ventilation: A Randomized Controlled Trial. Indian J Palliat Care. 2017 Oct-Dec;23(4):372-378. doi: 10.4103/IJPC.IJPC_84_17.
Results Reference
result
PubMed Identifier
32690406
Citation
Taplak AS, Bayat M. Comparison the Effect of Breast Milk Smell, White Noise and Facilitated Tucking Applied to Turkish Preterm Infants During Endotracheal Suctioning on Pain and Physiological Parameters. J Pediatr Nurs. 2021 Jan-Feb;56:e19-e26. doi: 10.1016/j.pedn.2020.07.001. Epub 2020 Jul 18.
Results Reference
result
PubMed Identifier
24503979
Citation
Stevens BJ, Gibbins S, Yamada J, Dionne K, Lee G, Johnston C, Taddio A. The premature infant pain profile-revised (PIPP-R): initial validation and feasibility. Clin J Pain. 2014 Mar;30(3):238-43. doi: 10.1097/AJP.0b013e3182906aed.
Results Reference
result
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
32062050
Citation
Apaydin Cirik V, Efe E. The effect of expressed breast milk, swaddling and facilitated tucking methods in reducing the pain caused by orogastric tube insertion in preterm infants: A randomized controlled trial. Int J Nurs Stud. 2020 Apr;104:103532. doi: 10.1016/j.ijnurstu.2020.103532. Epub 2020 Jan 24.
Results Reference
result
PubMed Identifier
29345047
Citation
Kucuk Alemdar D, Guducu TufekcI F. Effects of maternal heart sounds on pain and comfort during aspiration in preterm infants. Jpn J Nurs Sci. 2018 Oct;15(4):330-339. doi: 10.1111/jjns.12202. Epub 2018 Jan 17.
Results Reference
result
PubMed Identifier
25779636
Citation
Cardoso JM, Kusahara DM, Guinsburg R, Pedreira ML. Randomized crossover trial of endotracheal tube suctioning systems use in newborns. Nurs Crit Care. 2017 Sep;22(5):276-283. doi: 10.1111/nicc.12170. Epub 2015 Mar 16.
Results Reference
result

Learn more about this trial

Pain and Comfort During Endotracheal Suction in Premature Neonates

We'll reach out to this number within 24 hrs