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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.

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05046834
Enrollment
0
Registered
2021-09-16
Start date
2026-10-15
Completion date
2026-10-15
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Tube Removal

Keywords

Chest Tube Removal, cold application, pain

Brief 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.

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.

Interventions

OTHERcold 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.

OTHERcold 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.

Sponsors

Muğla Sıtkı Koçman University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Months to 3 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain assessed by FLACCbefore cold application,the intensity of pain at the chest tube
vital signsbefore cold application,pulse, oxygen saturation, temperature, respiratory rate.

Secondary

MeasureTime frameDescription
crying timeimmediately after chest tube removal ,crying time because of pain (SECOND)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026