Mobility LimitationNCT05081856
Use Modular Medical Equipment Vehicle in Mobilization of Patient With Chest Tube
A study of Mobility Limitation and Sleep Quality, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mobility Limitation, Sleep Quality, Pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 15 Jan 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- have a mental or psychological illness, hemodynamically unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- mobilization with moduler medical equipment carring vehicle
- Keywords
- care outcomes, mobilization, chest tube
- Medical subject headings
- Mobility Limitation, Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobilization with moduler medical equipment carring vehicleOther
Mobilization of the patients was carried out with the vehicle in their modular vehicle.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The group mobilized for at least 20 minutes 6 times a day with a modular medical equipment carrying vehicle Receives: Other: mobilization with moduler medical equipment carring vehicle |
| control group | No intervention | The group mobilized for at least 20 minutes 6 times a day with a routin practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
general comfort scale score
monitoring of changes in the general comfort levels of the patients during the intervention
Measured: first day and fifth day
Richard Campell sleep quality scale score
monitoring of changes in the sleep quality of the patients during the intervention
Measured: every day for five days
pain scale score
monitoring of changes in the pain levels of the patients during the intervention
Measured: every day for five days
patient mobility scale score
monitoring of changes in the mobility of the patients during the intervention
Measured: every day for five days
drain removal time (day (median))
monitoring of changes in the drain removal time of the patients during the intervention
Measured: the day the drain was removed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start1 Oct 2019
- Primary completion15 May 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional study with posttest control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pınar dogan, Istanbul Medipol University Hospital
- Investigators
- Pınar Dogan, Asst.Prof., Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081856
- Sponsor's protocol ID
- 12093487
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Modular Carrying System on Patient Outcomes in the Mobilization of Patients With a Chest Tube
- ClinicalTrials.gov ID
- NCT05081856
- Acronym / sponsor ID
- 12093487
- Keywords
- care outcomes, mobilization, chest tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 18 Oct 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, 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Interventional study with posttest control group
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: mobilization with moduler medical equipment carring vehicleThe group mobilized for at least 20 minutes 6 times a day with a modular medical equipment carrying vehicle |
| control group | No intervention | –The group mobilized for at least 20 minutes 6 times a day with a routin practice |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- have a mental or psychological illness, hemodynamically unstable
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 |
|---|---|---|
| mobilization with moduler medical equipment carring vehicleMobilization of the patients was carried out with the vehicle in their modular vehicle. | Other | intervention group |
Primary outcome
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
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
pain scale score
Time frame: every day for five days
monitoring of changes in the pain levels of the patients during the intervention
patient mobility scale score
Time frame: every day for five days
monitoring of changes in the mobility of the patients during the intervention
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
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 12 Aug 2024.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Mobility Limitation
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Recruiting
Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort
Joint Osteoarthritis, Atherosclerosis of the Distal Arteries, Without Gangrene
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingObservational study
Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
Tendinopathy
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.
Pınar Dogan, Asst.Prof. study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Mobility Limitation and Sleep Quality, run by Istanbul Medipol University Hospital 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 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 12 Aug 2024. 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 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?
general comfort scale score (time frame: first day and fifth day). The study lists 5 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 12 Aug 2024.