Chest Tube RemovalNCT05046834
Effect of Cold Application on Patient's Pain and Vital Signs During Chest Tube Removal.
A study testing cold application and cold application until 13.6 C in people with Chest Tube Removal, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 3 years
- Conditions the study is for
- Chest Tube Removal
- What is being tested?
- cold application and cold application until 13.6 C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children with any neurological diseases,
- Children with anynephrological
- Children with any respiratory diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chest Tube Removal
- Being tested
- cold application, cold application until 13.6 C
- Keywords
- Chest Tube Removal, cold application, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold applicationOther
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 until 13.6 COther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: cold application until 13.6 C |
| control Group | No intervention | standard pain procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed by FLACC
the intensity of pain at the chest tube
Measured: before cold application,
Pain assessed by FLACC
the intensity of pain at the chest tube
Measured: immediately after chest tube removal ,
Pain assessed by FLACC
the intensity of pain at the chest tube
Measured: 15 minutes after chest tube removal
vital signs
pulse, oxygen saturation, temperature, respiratory rate.
Measured: before cold application,
vital signs
pulse, oxygen saturation, temperature, respiratory rate.
Measured: immediately after chest tube removal ,
vital signs
pulse, oxygen saturation, temperature, respiratory rate.
Measured: 15 minutes after chest tube removal
Secondary outcomes (2)
crying time
crying time because of pain (SECOND)
Measured: immediately after chest tube removal ,
crying time
crying time because of pain. (SECOND)
Measured: 15 minutes after chest tube removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start15 Oct 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Why it stopped: Researchers' workload and the fact that they work at different institutions made it difficult to gather data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest Tube RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Karayagiz Muslu, Muğla Sıtkı Koçman University
- Investigators
- gonca muslu, Principal investigator, Muğla Sıtkı Koçman Universitydilek beytut, PhD, Study chair, KKTC Lefke Europe Universitysaime yıldırım, nurse, Study chair, Dr. Behçet Uz Child hospitalrecep kara, PhD student, Study chair, Muğla Sıtkı Koçman Universityfigen koyuncu, nurse, Study chair, Dr. Behçet Uz Child hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046834
- Sponsor's protocol ID
- 272
- Status last verified
- Jul 2024
- First submitted
- 15 Sep 2021
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Cold Application on Patient's Pain and Vital Signs During Chest Tube Removal.
- ClinicalTrials.gov ID
- NCT05046834
- Acronym / sponsor ID
- 272
- Conditions
- Chest Tube Removal
- Keywords
- Chest Tube Removal, cold application, pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Researchers' workload and the fact that they work at different institutions made it difficult to gather data.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cold application Group | Experimental | Other: cold applicationa 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 | Experimental | Other: cold application until 13.6 C10 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. |
| control Group | No intervention | –standard pain procedure. |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Children with any neurological diseases,
- Children with anynephrological
- Children with any respiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cold applicationOral 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. | Other | cold application Group |
| cold application until 13.6 CAfter 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. | Other | Cold Application Group with Thermometer |
Primary outcome
Pain assessed by FLACC
Time frame: before cold application,
the intensity of pain at the chest tube
Pain assessed by FLACC
Time frame: immediately after chest tube removal ,
the intensity of pain at the chest tube
Pain assessed by FLACC
Time frame: 15 minutes after chest tube removal
the intensity of pain at the chest tube
vital signs
Time frame: before cold application,
pulse, oxygen saturation, temperature, respiratory rate.
vital signs
Time frame: immediately after chest tube removal ,
pulse, oxygen saturation, temperature, respiratory rate.
vital signs
Time frame: 15 minutes after chest tube removal
pulse, oxygen saturation, temperature, respiratory rate.
2 secondary outcomes
crying time
Time frame: immediately after chest tube removal ,
crying time
Time frame: 15 minutes after chest tube removal
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
gonca muslu principal investigator
Muğla Sıtkı Koçman University
dilek beytut, PhD study chair
KKTC Lefke Europe University
saime yıldırım, nurse study chair
Dr. Behçet Uz Child hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold application and cold application until 13.6 C in people with Chest Tube Removal, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessed by FLACC (time frame: before cold application,). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.