Clinical trial NCT05046834: Effect of Cold Application on Patient's Pain and Vital Signs During Chest Tube Removal.
Official title: Investigation of the Effect of Cold Application on Patient's Pain and Vital Signs During Chest Tube Removal.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chest Tube Removal
Keywords: Chest Tube Removal, cold application, pain
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain assessed by FLACC
timeFrame: before cold application,
measure: Pain assessed by FLACC
timeFrame: immediately after chest tube removal ,
measure: Pain assessed by FLACC
timeFrame: 15 minutes after chest tube removal
measure: vital signs
timeFrame: before cold application,
measure: vital signs
timeFrame: immediately after chest tube removal ,
measure: vital signs
timeFrame: 15 minutes after chest tube removal
Secondary outcomes:
measure: crying time
timeFrame: immediately after chest tube removal ,
measure: crying time
timeFrame: 15 minutes after chest tube removal
Other outcomes:
Locations:
city: Fethiye
country: Turkey
facility: Gonca Muslu
state: Muğla
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: gonca muslu
role: PRINCIPAL_INVESTIGATOR
affiliation: KKTC Lefke Europe University
name: dilek beytut, PhD
role: STUDY_CHAIR
affiliation: Dr. Behçet Uz Child hospital
name: saime yıldırım, nurse
role: STUDY_CHAIR
affiliation: Muğla Sıtkı Koçman University
name: recep kara, PhD student
role: STUDY_CHAIR
affiliation: Dr. Behçet Uz Child hospital
name: figen koyuncu, nurse
role: STUDY_CHAIR
References: