Chest Tube RemovalNCT03307239
Cold Application on Pain During Chest Tube Removal
A study testing cold application and tap water packs application in people with Chest Tube Removal, run by Chiayi Christian Hospital.
Trial summary
Abstract Objectives: Use of analgesics is the most common method to alleviate the pain induced by chest tube removal (CTR), but patient response to medication can vary and may not be achieved complete relaxation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chest Tube Removal
- What is being tested?
- cold application and tap water packs application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2014to 15 Sep 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (a) age greater than 20 years, (b) single chest-tube insertion, (c) first-time insertion of the chest tube, (d) ability to verbally report pain, (e) body mass index of < 30 kg/m2, and (f) normal vital signs.
Who cannot join
- cold urticaria
About this study
Official title: Efficacy of Cold Application on Pain During Chest Tube Removal: A Randomized Controlled Trial : A CONSORT Compliant Article
Abstract Objectives: Use of analgesics is the most common method to alleviate the pain induced by chest tube removal (CTR), but patient response to medication can vary and may not be achieved complete relaxation. This study was to determine the effectiveness of cold application in combination with standard analgesic administration before CTR on CTR-induced pain.
Methods: A prospective, randomized, single-blind, placebo sham-controlled study was conducted. In addition to the same routine care, subjects in the experimental group (n = 30) received cold application of 600 g ice packs 15 minutes before CTR, whereas subjects in the placebo sham group (n = 30) received tap water packs. Numerical rating scale was used to measured pain intensity before, immediately after, and 10 minutes after CTR.
- Conditions
- Chest Tube Removal
- Being tested
- cold application, tap water packs application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold applicationOther
We manufactured two ice packs (17 × 12 cm) with a combined weight of 600 g. The ice packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the ice packs was approximately 25 cm in diameter around the chest tube.
For patients of the experimental group, they were received 15-minutes cold application.
tap water packs applicationOther
We manufactured two tap water packs (17 × 12 cm) with a combined weight of 600 g. The tap water packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the tap water packs was approximately 25 cm in diameter around the chest tube.
For patients of the sham group, they were received 15-minutes tap water application.
| Study group | Role | What they receive |
|---|---|---|
| cold application (experimental group) | Experimental | subjects in the experimental group (n = 30) received cold application of 600 g ice packs 15 minutes before CTR Receives: Other: cold application |
| tap water packs application (sham group) | Sham comparator | subjects in the sham group (n = 30) received tap water packs. Receives: Other: tap water packs application |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale (NRS)
the intensity of pain at the chest tube replacement
Measured: before cold application
numerical rating scale (NRS)
the intensity of pain at the chest tube removal
Measured: immediately after chest tube removal
numerical rating scale (NRS)
the intensity of pain at the chest tube removal
Measured: 10 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 posted11 Oct 2017
- Study start15 Sep 2014
- Primary completion15 Sep 2015
- Study completion15 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- subjects in the experimental group received cold application of 600 g ice packs 15 min before CTR, whereas subjects in the sham group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307239
- Sponsor's protocol ID
- 103044
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsieh LY, Chen YR, Lu MC. Efficacy of cold application on pain during chest tube removal: a randomized controlled trial: A CONSORT-compliant article. Medicine (Baltimore). 2017 Nov;96(46):e8642. doi: 10.1097/MD.0000000000008642.
PubMed 29145288
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cold Application on Pain During Chest Tube Removal: A Randomized Controlled Trial : A CONSORT Compliant Article
- ClinicalTrials.gov ID
- NCT03307239
- Acronym / sponsor ID
- 103044
- Conditions
- Chest Tube Removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 15 Sep 2015 (actual)
- Study completion
- 15 Sep 2015 (actual)
- First posted
- 11 Oct 2017 (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.
Abstract Objectives: Use of analgesics is the most common method to alleviate the pain induced by chest tube removal (CTR), but patient response to medication can vary and may not be achieved complete relaxation. This study was to determine the effectiveness of cold application in combination with standard analgesic administration before CTR on CTR-induced pain.
Methods: A prospective, randomized, single-blind, placebo sham-controlled study was conducted. In addition to the same routine care, subjects in the experimental group (n = 30) received cold application of 600 g ice packs 15 minutes before CTR, whereas subjects in the placebo sham group (n = 30) received tap water packs. Numerical rating scale was used to measured pain intensity before, immediately after, and 10 minutes after CTR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- subjects in the experimental group received cold application of 600 g ice packs 15 min before CTR, whereas subjects in the sham group
| Arm | Type | Receives |
|---|---|---|
| cold application (experimental group) | Experimental | Other: cold applicationsubjects in the experimental group (n = 30) received cold application of 600 g ice packs 15 minutes before CTR |
| tap water packs application (sham group) | Sham comparator | Other: tap water packs applicationsubjects in the sham group (n = 30) received tap water packs. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (a) age greater than 20 years, (b) single chest-tube insertion, (c) first-time insertion of the chest tube, (d) ability to verbally report pain, (e) body mass index of < 30 kg/m2, and (f) normal vital signs.
Key exclusion criteria (1 listed)
- cold urticaria
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 applicationWe manufactured two ice packs (17 × 12 cm) with a combined weight of 600 g. The ice packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the ice packs was approximately 25 cm in diameter around the chest tube. For patients of the experimental group, they were received 15-minutes cold application. | Other | cold application (experimental group) |
| tap water packs applicationWe manufactured two tap water packs (17 × 12 cm) with a combined weight of 600 g. The tap water packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the tap water packs was approximately 25 cm in diameter around the chest tube. For patients of the sham group, they were received 15-minutes tap water application. | Other | tap water packs application (sham group) |
Primary outcome
numerical rating scale (NRS)
Time frame: before cold application
the intensity of pain at the chest tube replacement
numerical rating scale (NRS)
Time frame: immediately after chest tube removal
the intensity of pain at the chest tube removal
numerical rating scale (NRS)
Time frame: 10 minutes after chest tube removal
the intensity of pain at the chest tube removal
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 11 Oct 2017.
- Derived from this study: PubMed 29145288Hsieh LY, Chen YR, Lu MC. Efficacy of cold application on pain during chest tube removal: a randomized controlled trial: A CONSORT-compliant article. Medicine (Baltimore). 2017 Nov;96(46):e8642. doi: 10.1097/MD.0000000000008642.
- Individual participant dataSharing planned: No
Related trials for Chest Tube Removal
Not yet recruiting
Effect of Box Breathing Before Chest Tube Removal After Open-Heart Surgery
Open-Heart Surgery
Recruiting
The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters
Congenital Heart Disease (CHD), Chest Tube Removal
Active, not recruiting
Effects of Vibration and Breathing Exercises on Pain and Anxiety During Chest Tube Removal
Postoperative Pain, Anxiety
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
Recruiting
Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries
Lung Pathologies of Unclear Etiology
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 and tap water packs application in people with Chest Tube Removal, run by Chiayi Christian Hospital.
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 1 inclusion and 1 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 11 Oct 2017. 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. Some participants in this study may receive a placebo. 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?
numerical rating scale (NRS) (time frame: before cold application). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03307239, which also lists 1 linked publication.
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 11 Oct 2017.