- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05081856
Use Modular Medical Equipment Vehicle in Mobilization of Patient With Chest Tube
October 5, 2021 updated by: Istanbul Medipol University Hospital
The Effect of Modular Carrying System on Patient Outcomes in the Mobilization of Patients With a Chest Tube
in this study, it was aimed to examine the effect of the modular carrying system on the outcomes of care in the mobilization of patients with a chest tube.
The population of the study consisted of patients followed in Yedikule Chest Diseases, and Thoracic Surgery Training and Research Hospital between October 2019 and January 2021, and the sample consisted of 83 patients who met the inclusion criteria.
The study was performed with the intervention group (n=37) mobilized with the Modular medical equipment carrying vehicle and the control group (n=46) mobilized with the routine application.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Within the scope of the study, a Modular medical equipment carrying vehicle was developed by the researchers to ensure the safe and comfortable mobilization of patients with chest tube and additional medical equipment.
This vehicle has been designed to maintain the level of the chest tube during mobilization and to prevent it from tipping over.Patients in the intervention group were mobilized with the help of this Modular medical equipment carrying vehicle for 20 minutes at least 6 times a day.
Patients in the control group were mobilized at least 6 times a day for 20 minutes with clinical routine practice.
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Istanbul Medipol University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- chest tube inserted due to open surgery, hemodynamically stable, followed up in the clinic for at least 5 days, first mobilized after chest tube inserted
Exclusion Criteria:
- have a mental or psychological illness, hemodynamically unstable
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention group
The group mobilized for at least 20 minutes 6 times a day with a modular medical equipment carrying vehicle
|
Mobilization of the patients was carried out with the vehicle in their modular vehicle.
|
No Intervention: control group
The group mobilized for at least 20 minutes 6 times a day with a routin practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
general comfort scale score
Time Frame: first day and fifth day
|
monitoring of changes in the general comfort levels of the patients during the intervention
|
first day and fifth day
|
Richard Campell sleep quality scale score
Time Frame: every day for five days
|
monitoring of changes in the sleep quality of the patients during the intervention
|
every day for five days
|
pain scale score
Time Frame: every day for five days
|
monitoring of changes in the pain levels of the patients during the intervention
|
every day for five days
|
patient mobility scale score
Time Frame: every day for five days
|
monitoring of changes in the mobility of the patients during the intervention
|
every day for five days
|
drain removal time (day (median))
Time Frame: the day the drain was removed
|
monitoring of changes in the drain removal time of the patients during the intervention
|
the day the drain was removed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Pınar Dogan, Asst.Prof., Medipol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
May 15, 2020
Study Completion (Actual)
January 15, 2021
Study Registration Dates
First Submitted
August 16, 2021
First Submitted That Met QC Criteria
October 5, 2021
First Posted (Actual)
October 18, 2021
Study Record Updates
Last Update Posted (Actual)
October 18, 2021
Last Update Submitted That Met QC Criteria
October 5, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12093487
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data from the study will be reported over the levels of change in maintenance results.
The study report is aimed to be published as a clinical research report.
IPD Sharing Time Frame
Data will be used for 2 years
IPD Sharing Access Criteria
increase in sleep, comfort and mobility level of patients mobilized with this tool, decrease in pain and drain removal time
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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