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

NCT05046834 | Withdrawn

• 1 other identifier: 272
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Tube Removal

Keywords

Chest Tube Removal, cold application, pain

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• crying time

  immediately after chest tube removal ,

• crying time

  15 minutes after chest tube removal

Study Arms (3)

cold application Group

EXPERIMENTAL

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

Cold Application Group with Thermometer

EXPERIMENTAL

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

control Group

NO INTERVENTION

standard pain procedure.

Interventions

cold application 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

cold application until 13.6 C 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.

Cold Application Group with Thermometer

Eligibility Criteria

• Age: 1 Month - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children with any neurological diseases,
• Children with anynephrological
• Children with any respiratory diseases

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Gonca Muslu

Fethiye, Muğla, 48300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• gonca muslu

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

• dilek beytut, PhD

  KKTC Lefke Europe University

  STUDY CHAIR

• saime yıldırım, nurse

  Dr. Behçet Uz Child hospital

  STUDY CHAIR

• recep kara, PhD student

  Muğla Sıtkı Koçman University

  STUDY CHAIR

• figen koyuncu, nurse

  Dr. Behçet Uz Child hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 16, 2021
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: September 30, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)