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Pain and Comfort During Endotracheal Suction in Premature Neonates

I

Istanbul Aydın University

Status

Completed

Conditions

Premature

Treatments

Other: Oropharyngeal colostrum
Other: Swaddling

Study type

Interventional

Funder types

Other

Identifiers

NCT05095285
IstanbulAU

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

1 to 5 days old

Volunteers

Accepts 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 3 patient groups

The control group
No Intervention group
Description:
• In addition to incubator cover and nesting, no other non-pharmacological intervention was applied to the control group.
The swaddling group
Experimental group
Description:
•Babies in this group were wrapped with a white cheesecloth 2 minutes before ES in addition to incubator cover and nesting.
Treatment:
Other: Swaddling
The oropharyngeal colostrum group
Experimental group
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.
Treatment:
Other: Oropharyngeal colostrum

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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