Local Application / Packing Too ColdNCT04200859
Effect of Cold Application Materials on Pain During Chest Tube Removal
A study testing Cold application in people with Local Application / Packing Too Cold, run by Mersin University.
Trial summary
Background: Despite being an important treatment intervention, chest tube causes severe pain during removal because it attaches to the endothelium in the chest cavity. Objectives: This study aimed to determine the effectiveness of cold application with ice pack and gel pad in the control of pain experienced during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Local Application / Packing Too Cold
- What is being tested?
- Cold application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- had chest tube
- Must be conscious, orientated and cooperated
- Must be able to speak and understand Turkish
Who cannot join
- Psychiatric disease
- Language problems
About this study
Official title: The Effect of Different Cold Application Materials on Pain During Chest Tube Removal: A Randomized Controlled Trial
Background: Despite being an important treatment intervention, chest tube causes severe pain during removal because it attaches to the endothelium in the chest cavity.
Objectives: This study aimed to determine the effectiveness of cold application with ice pack and gel pad in the control of pain experienced during chest tube removal.
Read more
Design: Prospective, parallel three armed, randomized controlled trial. Settings: The study was conducted in athoracic surgery unit of a university hospital.
Methods: The sample of this study consisted of 180 patients in two experimental groups and one control group.The patients were randomly assigned by a computer program to either intervention groups (ice pack or gel pad) or control group.One experimental group received cold application using ice pack and the other received cold application using gel pad until the skin temperature of all the patients fell to 13.6°C. The control group did not receive any intervention. Pain severity was assessed with Numerical Rating Scale (NRS) before chest tube removal, at the end of the procedure and 15 minutes after the procedure. Data was analyzed using descriptive statistics, chi-square, student t-test in independent groups, one-way analysis of variance (ANOVA), and repeated measures ANOVA.
Read the detailed description
This study was aimed to determine which cold application material is more effective in pain control of patients during chest tube removal process.
The primary outcomes measures of this study were the effect of cold application materials on severity of pain.The secondary outcome measures of this study were duration of cold application and analgesic requirements of the patients.
Procedure Before removal of chest tube, nurse researcher (DS) who is working in the thoracic surgery clinic as a nurse, explained aim of study and take informed consent all patients. Data were collected with Patient Information Form and NRS.
Patient Information Form was filled out for each using the information obtained from patients/patients' relatives, patient files and health professionals of the clinic and the patients' pain severity was measured with NRS.
The patients were randomly assigned by a computer program to either intervention groups (ice pack or gel pad) or control group. Before the chest tube was removed, nurse researcher (DS) made cold application with ice pack the first experimental group and cold application with gel pad the second experimental group. The control group did not receive any intervention. Since the cold application temperature should be reduced to 13.6 °C in order to have local analgesic effect in both of the experimental groups the patient's skin temperature was measured at one-minute intervals by using an infrared non-contact thermometer (Microlife Non-Contact, Switzerland) with a wide measurement range (0-100 °C) and a measurement time of three seconds. This application was terminated when the temperature was 13.6 °C and the chest tube was removed by the physician.
Pain severity of all the patients was measured with NRS immediately after and 15 minutes after chest tube removal.
- Conditions
- Local Application / Packing Too Cold
- Being tested
- Cold application
- Keywords
- chest tube,, chest tube removal, pain, cold aplication, nursing
- 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
cold application using ice pack/gel pad in the control of pain experienced during chest tube removal
| Study group | Role | What they receive |
|---|---|---|
| Cold application with ice pack | Experimental | Before the chest tube was removed, two ice packs with a size of 15.5x9cm were inserted around the chest tube so as to make as much contact as possible Receives: Other: Cold application |
| Cold application with gel pad group | Experimental | Before the chest tube was removed, a gel pad with a radius of 15 cm was completely inserted around the chest tube Receives: Other: Cold application |
| Control group | No intervention | Routine analgesic drugs are not administered to patients before removal of the chest tube in thoracic surgery clinic. However, analgesic is performed according to the severity of pain after the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of cold application materials on severity of pain
Numerical Rating Scale: The scale was used to determine the severity of pain during chest tube removal process. On this scale, patients are asked to describe their pain with numbers, with "0" indicating "no pain" and "10" indicating "the worst, unbearable pain"
Measured: Change from first NRS at 15 minutes
Secondary outcomes (2)
effect of cold application materials on duration of cold application
The Patients Information Form was used to determine patients duration of cold application. How many minutes of cold application material applied
Measured: 30 minutes
effect of cold application materials on analgesic requirements of the patients
The Patients Information Form was used to determine presence of analgesic administration after chest tube removal, time passed between the last analgesic time and chest tube removal time and time passed between chest tube removal time and the first analgesic administration time.
Measured: up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study startSep 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Application / Packing Too ColdStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel three armed, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay ALTUN UGRAS, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200859
- Sponsor's protocol ID
- Mersin University
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Cold Application Materials on Pain During Chest Tube Removal: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04200859
- Acronym / sponsor ID
- Mersin University
- Conditions
- Local Application / Packing Too Cold
- Keywords
- chest tube,, chest tube removal, pain, cold aplication, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 16 Dec 2019 (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.
Background: Despite being an important treatment intervention, chest tube causes severe pain during removal because it attaches to the endothelium in the chest cavity.
Objectives: This study aimed to determine the effectiveness of cold application with ice pack and gel pad in the control of pain experienced during chest tube removal.
Design: Prospective, parallel three armed, randomized controlled trial. Settings: The study was conducted in athoracic surgery unit of a university hospital.
Methods: The sample of this study consisted of 180 patients in two experimental groups and one control group.The patients were randomly assigned by a computer program to either intervention groups (ice pack or gel pad) or control group.One experimental group received cold application using ice pack and the other received cold application using gel pad until the skin temperature of all the patients fell to 13.6°C. The control group did not receive any intervention. Pain severity was assessed with Numerical Rating Scale (NRS) before chest tube removal, at the end of the procedure and 15 minutes after the procedure. Data was analyzed using descriptive statistics, chi-square, student t-test in independent groups, one-way analysis of variance (ANOVA), and repeated measures ANOVA.
Detailed description
This study was aimed to determine which cold application material is more effective in pain control of patients during chest tube removal process.
The primary outcomes measures of this study were the effect of cold application materials on severity of pain.The secondary outcome measures of this study were duration of cold application and analgesic requirements of the patients.
Procedure Before removal of chest tube, nurse researcher (DS) who is working in the thoracic surgery clinic as a nurse, explained aim of study and take informed consent all patients. Data were collected with Patient Information Form and NRS.
Patient Information Form was filled out for each using the information obtained from patients/patients' relatives, patient files and health professionals of the clinic and the patients' pain severity was measured with NRS.
The patients were randomly assigned by a computer program to either intervention groups (ice pack or gel pad) or control group. Before the chest tube was removed, nurse researcher (DS) made cold application with ice pack the first experimental group and cold application with gel pad the second experimental group. The control group did not receive any intervention. Since the cold application temperature should be reduced to 13.6 °C in order to have local analgesic effect in both of the experimental groups the patient's skin temperature was measured at one-minute intervals by using an infrared non-contact thermometer (Microlife Non-Contact, Switzerland) with a wide measurement range (0-100 °C) and a measurement time of three seconds. This application was terminated when the temperature was 13.6 °C and the chest tube was removed by the physician.
Pain severity of all the patients was measured with NRS immediately after and 15 minutes after chest tube removal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective, parallel three armed, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cold application with ice pack | Experimental | Other: Cold applicationBefore the chest tube was removed, two ice packs with a size of 15.5x9cm were inserted around the chest tube so as to make as much contact as possible |
| Cold application with gel pad group | Experimental | Other: Cold applicationBefore the chest tube was removed, a gel pad with a radius of 15 cm was completely inserted around the chest tube |
| Control group | No intervention | –Routine analgesic drugs are not administered to patients before removal of the chest tube in thoracic surgery clinic. However, analgesic is performed according to the severity of pain after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- had chest tube
- Must be conscious, orientated and cooperated
- Must be able to speak and understand Turkish
Key exclusion criteria (2 listed)
- Psychiatric disease
- Language problems
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 applicationcold application using ice pack/gel pad in the control of pain experienced during chest tube removal | Other | Cold application with gel pad group, Cold application with ice pack |
Primary outcome
effect of cold application materials on severity of pain
Time frame: Change from first NRS at 15 minutes
Numerical Rating Scale: The scale was used to determine the severity of pain during chest tube removal process. On this scale, patients are asked to describe their pain with numbers, with "0" indicating "no pain" and "10" indicating "the worst, unbearable pain"
2 secondary outcomes
effect of cold application materials on duration of cold application
Time frame: 30 minutes
effect of cold application materials on analgesic requirements of the patients
Time frame: up to 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cold application in people with Local Application / Packing Too Cold, run by Mersin University.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
effect of cold application materials on severity of pain (time frame: Change from first NRS at 15 minutes). 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 16 Dec 2019.