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Clinical Trials/NCT06622330
NCT06622330
Completed
N/A

The Effect of Position Change on Pain and Cerebral Oxygen Saturation After Endotracheal Aspiration

Istanbul Medipol University Hospital1 site in 1 country70 target enrollmentJanuary 1, 2023
ConditionsChildren

Overview

Phase
N/A
Intervention
Not specified
Conditions
Children
Sponsor
Istanbul Medipol University Hospital
Enrollment
70
Locations
1
Primary Endpoint
Behavioral Pain Scale
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study is a randomized controlled experimental study to investigate the effect of position change on pain and cerebral oxygen saturation after endotracheal aspiration in pediatric patients.

Detailed Description

This study is a randomized controlled experimental study to investigate the effect of position change on pain and cerebral oxygen saturation after endotracheal aspiration in pediatric patients. The study sample consisted of 70 pediatric patients (35 in the control group and 35 in the intervention group) who met the inclusion criteria and whose parents gave informed consent. The research data were collected using the "Child Identification Form" and the "Behavioral Pain Scale". SPSS 24 program was used to analyze the data obtained in the study. Children in the experimental group were given 30 minutes of wrapping and 30 minutes of fetal position after aspiration. Children in the control group did not receive any treatment.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
August 29, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Medipol University Hospital
Responsible Party
Principal Investigator
Principal Investigator

aysel kokcudogan

Ph.D., Asst. Prof.

Istanbul Medipol University Hospital

Eligibility Criteria

Inclusion Criteria

  • Pediatric patients whose consent form is signed by their legal guardian
  • Intubated pediatric patients receiving mechanical ventilation support
  • Non-sedatized pediatric patients
  • Pediatric patients who have received only paracetamol and whose duration of action has exceeded 4-6 hours

Exclusion Criteria

  • Unconscious pediatric patients
  • Pediatric patients receiving pharmacologic drugs other than paracetamol
  • Unstable pediatric patients
  • Pediatric patients with painful procedures during the procedure

Outcomes

Primary Outcomes

Behavioral Pain Scale

Time Frame: Measured before aspiration, 1 and 2 hours after aspiration. Each measurement lasted 10 minutes.

Determines the pain level of children. In this scale, there are three items including facial expression, upper extremities and ventilator compliance and four variables including behavioral responses to pain in each item. These are; facial expression (relaxed, partially relaxed, fully tense, grimace), upper extremities (no movement, partially flexed, fully flexed), fingers (flexed, continuously retracted), compliance with ventilation (tolerates ventilation, coughs, but often tolerates ventilation, fights with ventilator, cannot control ventilation). Each question is given a score between 1-4. The lowest score is 3 and the highest score is 12. The higher the score, the more severe the pain.

Cerebral oxygen saturation

Time Frame: Measured before aspiration, 1 and 2 hours after aspiration. Each measurement lasted 10 minutes.

It was measured to determine the cerebral oxygen saturation of children.

Study Sites (1)

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