Use Modular Medical Equipment Vehicle in Mobilization of Patient With Chest Tube
Primary Purpose
Mobility Limitation, Sleep Quality, Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
mobilization with moduler medical equipment carring vehicle
Sponsored by
About this trial
This is an interventional other trial for Mobility Limitation focused on measuring care outcomes, mobilization, chest tube
Eligibility Criteria
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
Sites / Locations
- Istanbul Medipol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
The group mobilized for at least 20 minutes 6 times a day with a modular medical equipment carrying vehicle
The group mobilized for at least 20 minutes 6 times a day with a routin practice
Outcomes
Primary Outcome Measures
general comfort scale score
monitoring of changes in the general comfort levels of the patients during the intervention
Richard Campell sleep quality scale score
monitoring of changes in the sleep quality of the patients during the intervention
pain scale score
monitoring of changes in the pain levels of the patients during the intervention
patient mobility scale score
monitoring of changes in the mobility of the patients during the intervention
drain removal time (day (median))
monitoring of changes in the drain removal time of the patients during the intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT05081856
First Posted
August 16, 2021
Last Updated
October 5, 2021
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05081856
Brief Title
Use Modular Medical Equipment Vehicle in Mobilization of Patient With Chest Tube
Official Title
The Effect of Modular Carrying System on Patient Outcomes in the Mobilization of Patients With a Chest Tube
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation, Sleep Quality, Pain, Comfort, Time of the Removal Chest Tube
Keywords
care outcomes, mobilization, chest tube
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional study with posttest control group
Masking
Participant
Allocation
Non-Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
The group mobilized for at least 20 minutes 6 times a day with a modular medical equipment carrying vehicle
Arm Title
control group
Arm Type
No Intervention
Arm Description
The group mobilized for at least 20 minutes 6 times a day with a routin practice
Intervention Type
Other
Intervention Name(s)
mobilization with moduler medical equipment carring vehicle
Intervention Description
Mobilization of the patients was carried out with the vehicle in their modular vehicle.
Primary Outcome Measure Information:
Title
general comfort scale score
Description
monitoring of changes in the general comfort levels of the patients during the intervention
Time Frame
first day and fifth day
Title
Richard Campell sleep quality scale score
Description
monitoring of changes in the sleep quality of the patients during the intervention
Time Frame
every day for five days
Title
pain scale score
Description
monitoring of changes in the pain levels of the patients during the intervention
Time Frame
every day for five days
Title
patient mobility scale score
Description
monitoring of changes in the mobility of the patients during the intervention
Time Frame
every day for five days
Title
drain removal time (day (median))
Description
monitoring of changes in the drain removal time of the patients during the intervention
Time Frame
the day the drain was removed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pınar Dogan, Asst.Prof.
Organizational Affiliation
Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Use Modular Medical Equipment Vehicle in Mobilization of Patient With Chest Tube
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