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

Not Applicable

Recruiting

• Conditions: Chest Tube Removal
• Interventions: Other: cold application; Other: cold application until 13.6 C

• Registration Number: NCT05046834
• Lead Sponsor: Muğla Sıtkı Koçman University

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.

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Study Start: 2026-10-15
• Primary Completion: 2026-10-15
• Study Completion: 2026-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cold application Group	cold application	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.
Cold Application Group with Thermometer	cold application until 13.6 C	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.

Primary Outcome Measures

Name	Time	Method
Pain assessed by FLACC	15 minutes after chest tube removal	the intensity of pain at the chest tube
vital signs	15 minutes after chest tube removal	pulse, oxygen saturation, temperature, respiratory rate.

Secondary Outcome Measures

Name	Time	Method
crying time	15 minutes after chest tube removal	crying time because of pain. (SECOND)

Trial Locations

Locations (1)

Gonca Muslu; 🇹🇷 Fethiye, Muğla, Turkey