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NCT Number: NCT06622330

The Effect of Position Change on Pain and Cerebral Oxygen Saturation

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.

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Key information

Conditions

Children Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positioning

Other

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 2, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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