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The Effect of Position Change on Pain and Cerebral Oxygen Saturation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06622330
Enrollment
70
Registered
2024-10-02
Start date
2023-01-01
Completion date
2023-08-29
Last updated
2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children

Keywords

Pediatrics, position, pain, oxygen saturation

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.

Interventions

Children in the experimental group were given 30 minutes of wrapping and 30 minutes of fetal position after aspiration.

Sponsors

Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Behavioral Pain ScaleMeasured 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 saturationMeasured before aspiration, 1 and 2 hours after aspiration. Each measurement lasted 10 minutes.It was measured to determine the cerebral oxygen saturation of children.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026