Pain and Comfort During Endotracheal Suction in Premature Neonates
NCT ID: NCT05095285
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2019-07-01
2020-10-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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The control group
• In addition to incubator cover and nesting, no other non-pharmacological intervention was applied to the control group.
No interventions assigned to this group
The swaddling group
•Babies in this group were wrapped with a white cheesecloth 2 minutes before ES in addition to incubator cover and nesting.
Swaddling
* 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.
The oropharyngeal colostrum group
• 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.
Oropharyngeal colostrum
* 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.
Interventions
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Swaddling
* 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.
Oropharyngeal colostrum
* 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Having a history of convulsions
* Any extremity fracture/dislocation that will prevent wrapping
* Having a pneumothorax tube
1 Day
5 Days
ALL
Yes
Sponsors
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Istanbul Aydın University
OTHER
Responsible Party
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Huriye Karadede
Research Assistant
Principal Investigators
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Birsen Mutlu, Ass. Prof.
Role: STUDY_DIRECTOR
Istanbul University - Cerrahpasa
Locations
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Istanbul Aydin University
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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IstanbulAU
Identifier Type: -
Identifier Source: org_study_id