The Effect of Position Change on Pain and Cerebral Oxygen Saturation

NCT ID: NCT06622330

Last Updated: 2024-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-08-29

Brief Summary

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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

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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.

Conditions

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Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group given position

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

Group Type EXPERIMENTAL

Positioning

Intervention Type OTHER

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

Control group

No intervention was made to the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Positioning

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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aysel kokcudogan

Ph.D., Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysel Kökcü Doğan

Role: STUDY_DIRECTOR

444 85 44

Aysel Kökcü Doğan

Role: STUDY_DIRECTOR

Istanbul Medipol UniversityInstitute of Health Sciences

Locations

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Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E-15916306-604.01.01-209306724

Identifier Type: -

Identifier Source: org_study_id

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