Effect of Cold Application on Patient's Pain and Vital Signs During Chest Tube Removal.

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2026-10-15

Study Completion Date

2026-10-15

Brief Summary

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In this study, the effect of cold application used during and after chest tube removal on pain and vital signs in infants and children in the 0-3 age group will be examined.

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Detailed Description

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Purpose of the research:In this study, the effect of cold application used during and after breast tube removal on pain and life signs in infants and children aged 0-3 years will be examined.

Hypotheses:

H1: children who have cold application around the tube 15 minutes before chest tube removal have low pain scores during chest tube removal compared to other groups.

H2: Children whose skin temperature is lowered below 13.60 C before breast tube removal have lower pain scores compared to other groups.

H3: The cold application technique in the group of children affects the crying time after the procedure.

H4: The cold application technique in the group of children affects the signs of life before and after the procedure.

The research is a study in randomized controlled, prospective and cross-sectional design.

The data of the study will be collected using the Patient Identification Information Form, FLACC Pain Scale, Life Signs Follow-up Form.

Conditions

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Chest Tube Removal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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cold application Group

a cold gel pack will be wrapped in gauze and placed directly on the skin in an area with a radius of about 5 cm to cover the chest tube. The cold gel package will remain on the skin surface for about 20 minutes.

Group Type EXPERIMENTAL

cold application

Intervention Type OTHER

Oral paracetamol 10 mg/kg, which is administered as standard 60 minutes before the procedure, will be given to patients who have decided to remove the chest tube by the physician and comply with the limitations of the study. After that, initial pain severity and vital signs of the patient will be recorded using FLACC 15 minutes before the start of the chest tube removal process (1.MEASURE). After this measurement, the cold gel package will be wrapped in gauze and placed directly on the skin, covering the area around the chest tube with a radius of about 5 cm. The cold gel package will remain on the skin surface for about 20 minutes. After 15 minutes, the cold package will be removed and the chest tube will be removed by the doctor.

Cold Application Group with Thermometer

10 of cold application. After a minute, the skin temperature will be measured with an infrared thermometer if the temperature has dropped below 13.6 o C, the procedure will be terminated. If the skin temperature has not decreased below 13.6 0 C, the application will be continued, the application will be terminated when the temperature drops below the specified temperature.

Group Type EXPERIMENTAL

cold application until 13.6 C

Intervention Type OTHER

After measurements, the cold gel package, which rotates with one end open and forms a circle, will be wrapped in gauze and placed directly on the skin in a radius of about 5 cm, covering around the chest tube. 10 of the app. After the minute, the skin temperature will be measured with an infrared thermometer if the heat falls below 13.6 o C, the process will be terminated. If the skin temperature does not fall below 13.6 0 C, the application will continue, the application will be terminated when the heat falls below the specified temperature. After the cold package is removed, the chest tube will be removed by the doctor.

control Group

standard pain procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cold application

Oral paracetamol 10 mg/kg, which is administered as standard 60 minutes before the procedure, will be given to patients who have decided to remove the chest tube by the physician and comply with the limitations of the study. After that, initial pain severity and vital signs of the patient will be recorded using FLACC 15 minutes before the start of the chest tube removal process (1.MEASURE). After this measurement, the cold gel package will be wrapped in gauze and placed directly on the skin, covering the area around the chest tube with a radius of about 5 cm. The cold gel package will remain on the skin surface for about 20 minutes. After 15 minutes, the cold package will be removed and the chest tube will be removed by the doctor.

Intervention Type OTHER

cold application until 13.6 C

After measurements, the cold gel package, which rotates with one end open and forms a circle, will be wrapped in gauze and placed directly on the skin in a radius of about 5 cm, covering around the chest tube. 10 of the app. After the minute, the skin temperature will be measured with an infrared thermometer if the heat falls below 13.6 o C, the process will be terminated. If the skin temperature does not fall below 13.6 0 C, the application will continue, the application will be terminated when the heat falls below the specified temperature. After the cold package is removed, the chest tube will be removed by the doctor.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Between the ages of 0-3 years old,
* The chest tube is located for at least 24 hours,
* Without Mechanical ventilation support,
* Does not have any allergies to the drug
* Stable from the cardiovascular side