The Effect of Position Change on Pain and Cerebral Oxygen Saturation

NCT06622330 | Completed

• 1 other identifier: E-15916306-604.01.01-209306724
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Children

Keywords

Pediatrics; position; pain; oxygen saturation

Outcome Measures

Primary Outcomes (2)

• Behavioral Pain Scale

  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.

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

• Cerebral oxygen saturation

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

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

Study Arms (2)

Group given position

EXPERIMENTAL

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

Other: Positioning

Control group

NO INTERVENTION

No intervention was made to the control group.

Interventions

Positioning OTHER

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

Group given position

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Aysel Kökcü Doğan

  444 85 44

  STUDY DIRECTOR

• Aysel Kökcü Doğan

  Istanbul Medipol UniversityInstitute of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Asst. Prof.

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 2, 2024
• Study Start: January 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: August 29, 2023
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

TU (1)