Coronary Artery Bypass Graft SurgeryNCT05830682
Effect of Using Walking Aid on Mobility
A study testing using a walking aid in people with Coronary Artery Bypass Graft Surgery and Pain, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the effect of using walking aid during out-of-bed mobilization of patients who underwent open coronary artery bypass graft surgery on levels of pain and mobility. The main hypotheses are: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery, Pain, Early Mobilization
- What is being tested?
- using a walking aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jan 2019to 29 Jul 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- underwent elective CABG surgery for the first-time
- received sternotomy during surgery
- had saphenous vein grafting
- were within the first day after surgery
- being volunteered to participate in the study
Who cannot join
- patients who had a vein other than the saphenous vein grafting
- whose mobilization was not approved by the physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Using Walking Aid on Pain and Mobility Levels of Patients Underwent CABG Surgery
The goal of this clinical trial is to evaluate the effect of using walking aid during out-of-bed mobilization of patients who underwent open coronary artery bypass graft surgery on levels of pain and mobility. The main hypotheses are:
- The pain level of patients using walking aid is lower than that of those who do not.
- The mobility level of patients using walking aid is higher than that of those who do not.
Participants will be asked to walk with using a walking aid during the first three mobilizations in the intensive care unit on the first postoperative day.
Read the detailed description
Group allocation of the patients was done through using Random Allocation Software program and patients were allocated into two groups: the intervention group and the control group.
Patients in the intervention group were asked to o walk with using a walking aid during the first three mobilizations in the intensive care unit on the first postoperative day.
The researcher visited the patients in the CICU on the first day after surgery informed them that they were going to be mobilized out of the bed and walk in the room for two rounds (approximately 24 meters) for three times following each 4 hours by using a walking aid. The patients in the control group were informed that they were to be mobilized out of the bed and walk in the room for two rounds (approximately 24 meters) for three times following each 4 hours with the help of two nurses.
In the intervention group, to perform the first out-of-bed mobilization, the researcher and one other nurse supported helped the patient to straightening up in bed and then to sit in the bed. Then, the patient sat on the edge of the bed with their feet dangling outside. Following, with the brakes closed on the walking aid, the patient stood up from the bed and walked two rounds in the CICU room. The patient was then helped back to sit on the edge of the bed, and was asked to mark the level of pain and difficulty experienced during each activity on a horizontal line in the patient mobility scale.
The Patient Mobility Scale scale was developed to measure the pain and difficulty levels experienced by patients during four activities (turning from one side to the other/straightening up in bed, sitting on the edge of the bed, standing up from the bed, and walking in the room) in the postoperative period. To evaluate pain, patients are asked to mark their level of pain for each activity on a line ranging from 0-"no pain" to 5-"worst pain imaginable." To evaluate difficulty, patients are asked to mark their perceived difficulty for each activity on a line ranging from 0-"very easy" to 5-"very difficult". The total score of the patient mobility scale is derived by summing the pain and difficulty scores for all activities, with the lowest possible score being 0 and the highest score being 120. A lower score signifies that patients experienced less pain and difficulty during their activities, indicating a higher mobility level.
In the control group, to perform the first out-of-bed mobilization, the researcher and one other nurse supported helped the patient to straightening up in bed and then to sit in the bed. Then, the patient sat on the edge of the bed with their feet dangling outside. Following, two nurses helped the patient stood up from the bed and walk two rounds in the CICU room. The patient was then helped back to sit on the edge of the bed and was asked to mark the level of pain and difficulty experienced during each activity on a horizontal line in the patient mobility scale.
Four hours after the first and second mobilizations, both groups of patients underwent a new mobilization procedure, and the interventions applied during the first mobilization were repeated.
- Being tested
- using a walking aid
- Medical subject headings
- Pain, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using a walking aidDevice
The walking aid utilized for mobilizing patients in the intervention group during the study is a four-wheeled device that allows for movement in all directions. The height of the device can be adjusted according to the patients' height. It features a seat for resting when needed and a braking system that is controlled from the hand grips.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in this study group asked to walk with using a walking aid during the first three mobilizations in the intensive care unit on the first postoperative day. Receives: Device: using a walking aid |
| Control Group | No intervention | Participants in this study group asked to walk with the help of 2 nurses during the first three mobilizations in the intensive care unit on the first postoperative day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
will be evaluated with using the Patient Mobility Scale. To evaluate pain, patients are asked to mark their level of pain for each activity on a line ranging from 0-"no pain" to 5-"worst pain imaginable."
Measured: in the intensive care unit on the first postoperative day
Difficulty level
will be evaluated with using the Patient Mobility Scale. To evaluate difficulty, patients are asked to mark their perceived difficulty for each activity on a line ranging from 0-"very easy" to 5-"very difficult"
Measured: in the intensive care unit on the first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start29 Jan 2019
- Primary completion29 Jul 2019
- Study completion29 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft SurgeryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seher Ünver, Trakya University
- Investigators
- Seher Ünver, Principal investigator, Trakya UniversitySimge R Aktürk Tuncer, Principal investigator, Çorlu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830682
- Sponsor's protocol ID
- 2018/235
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Walking Aid on Pain and Mobility Levels of Patients Underwent CABG Surgery
- ClinicalTrials.gov ID
- NCT05830682
- Acronym / sponsor ID
- 2018/235
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 26 Apr 2023 (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.
The goal of this clinical trial is to evaluate the effect of using walking aid during out-of-bed mobilization of patients who underwent open coronary artery bypass graft surgery on levels of pain and mobility. The main hypotheses are:
- The pain level of patients using walking aid is lower than that of those who do not.
- The mobility level of patients using walking aid is higher than that of those who do not.
Participants will be asked to walk with using a walking aid during the first three mobilizations in the intensive care unit on the first postoperative day.
Detailed description
Group allocation of the patients was done through using Random Allocation Software program and patients were allocated into two groups: the intervention group and the control group.
Patients in the intervention group were asked to o walk with using a walking aid during the first three mobilizations in the intensive care unit on the first postoperative day.
The researcher visited the patients in the CICU on the first day after surgery informed them that they were going to be mobilized out of the bed and walk in the room for two rounds (approximately 24 meters) for three times following each 4 hours by using a walking aid. The patients in the control group were informed that they were to be mobilized out of the bed and walk in the room for two rounds (approximately 24 meters) for three times following each 4 hours with the help of two nurses.
In the intervention group, to perform the first out-of-bed mobilization, the researcher and one other nurse supported helped the patient to straightening up in bed and then to sit in the bed. Then, the patient sat on the edge of the bed with their feet dangling outside. Following, with the brakes closed on the walking aid, the patient stood up from the bed and walked two rounds in the CICU room. The patient was then helped back to sit on the edge of the bed, and was asked to mark the level of pain and difficulty experienced during each activity on a horizontal line in the patient mobility scale.
The Patient Mobility Scale scale was developed to measure the pain and difficulty levels experienced by patients during four activities (turning from one side to the other/straightening up in bed, sitting on the edge of the bed, standing up from the bed, and walking in the room) in the postoperative period. To evaluate pain, patients are asked to mark their level of pain for each activity on a line ranging from 0-"no pain" to 5-"worst pain imaginable." To evaluate difficulty, patients are asked to mark their perceived difficulty for each activity on a line ranging from 0-"very easy" to 5-"very difficult". The total score of the patient mobility scale is derived by summing the pain and difficulty scores for all activities, with the lowest possible score being 0 and the highest score being 120. A lower score signifies that patients experienced less pain and difficulty during their activities, indicating a higher mobility level.
In the control group, to perform the first out-of-bed mobilization, the researcher and one other nurse supported helped the patient to straightening up in bed and then to sit in the bed. Then, the patient sat on the edge of the bed with their feet dangling outside. Following, two nurses helped the patient stood up from the bed and walk two rounds in the CICU room. The patient was then helped back to sit on the edge of the bed and was asked to mark the level of pain and difficulty experienced during each activity on a horizontal line in the patient mobility scale.
Four hours after the first and second mobilizations, both groups of patients underwent a new mobilization procedure, and the interventions applied during the first mobilization were repeated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: using a walking aidParticipants in this study group asked to walk with using a walking aid during the first three mobilizations in the intensive care unit on the first postoperative day. |
| Control Group | No intervention | –Participants in this study group asked to walk with the help of 2 nurses during the first three mobilizations in the intensive care unit on the first postoperative day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- underwent elective CABG surgery for the first-time
- received sternotomy during surgery
- had saphenous vein grafting
- were within the first day after surgery
- being volunteered to participate in the study
Key exclusion criteria (2 listed)
- patients who had a vein other than the saphenous vein grafting
- whose mobilization was not approved by the physician
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 |
|---|---|---|
| using a walking aidThe walking aid utilized for mobilizing patients in the intervention group during the study is a four-wheeled device that allows for movement in all directions. The height of the device can be adjusted according to the patients' height. It features a seat for resting when needed and a braking system that is controlled from the hand grips. | Device | Intervention Group |
Primary outcome
Pain level
Time frame: in the intensive care unit on the first postoperative day
will be evaluated with using the Patient Mobility Scale. To evaluate pain, patients are asked to mark their level of pain for each activity on a line ranging from 0-"no pain" to 5-"worst pain imaginable."
Difficulty level
Time frame: in the intensive care unit on the first postoperative day
will be evaluated with using the Patient Mobility Scale. To evaluate difficulty, patients are asked to mark their perceived difficulty for each activity on a line ranging from 0-"very easy" to 5-"very difficult"
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 1 May 2023.
- Individual participant dataSharing planned: No
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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.
Seher Ünver principal investigator
Trakya University
Simge R Aktürk Tuncer principal investigator
Çorlu State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing using a walking aid in people with Coronary Artery Bypass Graft Surgery and Pain, run by Trakya University 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 5 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 1 May 2023. 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?
Pain level (time frame: in the intensive care unit on the first postoperative day). The study lists 2 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 1 May 2023; AzTrials last refreshed its copy on 27 Oct 2026.