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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chest Tube Removal
• Intervention / Treatment: Other: cold application; Other: cold application until 13.6 C

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Muğla
    • Fethiye, Muğla, Turkey, 48300
      • Gonca Muslu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.
No Intervention: control Group; standard pain procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessed by FLACC	the intensity of pain at the chest tube	before cold application,
Pain assessed by FLACC	the intensity of pain at the chest tube	immediately after chest tube removal ,
Pain assessed by FLACC	the intensity of pain at the chest tube	15 minutes after chest tube removal
vital signs	pulse, oxygen saturation, temperature, respiratory rate.	before cold application,
vital signs	pulse, oxygen saturation, temperature, respiratory rate.	immediately after chest tube removal ,
vital signs	pulse, oxygen saturation, temperature, respiratory rate.	15 minutes after chest tube removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
crying time	crying time because of pain (SECOND)	immediately after chest tube removal ,
crying time	crying time because of pain. (SECOND)	15 minutes after chest tube removal

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2023
• Primary Completion (Anticipated): October 15, 2024
• Study Completion (Anticipated): October 15, 2024

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Chest Tube Removal, cold application, pain
• Other Study ID Numbers: 272

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No