The Effect of Position Change on Pain and Cerebral Oxygen Saturation

Not Applicable

Completed

• Conditions: Children

• Registration Number: NCT06622330
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-04-01
• Study Completion: 2023-08-29
• Study First Submitted: 2024-09-29
• Study First Submitted QC: 2024-09-29
• Status Verified: 2024-10
• Study First Posted: 2024-10-02
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cerebral oxygen saturation	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.
Behavioral Pain Scale	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.

Trial Locations

Locations (1)

Istanbul Medipol University; 🇹🇷 Istanbul, Beykoz, Turkey