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

Chest Tube Removal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05046834
• Other study ID #: 272
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: October 15, 2024

Study information

• Verified date: March 2023
• Source: Mugla Sitki Koçman University
• Contact: GONCA MUSLU, PhD
• Phone: 9050539959224
• Email: goncamuslu[@]mu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 3 Years

Eligibility

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

Exclusion Criteria:

• Children with any neurological diseases,

• Children with anynephrological

• Children with any respiratory diseases

Related Conditions & MeSH terms

• Chest Tube Removal

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Gonca Muslu	Fethiye	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessed by FLACC	the intensity of pain at the chest tube	before cold application,
Primary	Pain assessed by FLACC	the intensity of pain at the chest tube	immediately after chest tube removal ,
Primary	Pain assessed by FLACC	the intensity of pain at the chest tube	15 minutes after chest tube removal
Primary	vital signs	pulse, oxygen saturation, temperature, respiratory rate.	before cold application,
Primary	vital signs	pulse, oxygen saturation, temperature, respiratory rate.	immediately after chest tube removal ,
Primary	vital signs	pulse, oxygen saturation, temperature, respiratory rate.	15 minutes after chest tube removal
Secondary	crying time	crying time because of pain (SECOND)	immediately after chest tube removal ,
Secondary	crying time	crying time because of pain. (SECOND)	15 minutes after chest tube removal