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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Seher Ünver

    Edirne, 22030

Other trials in Turkey (Türkiye)

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:

  1. The pain level of patients using walking aid is lower than that of those who do not.
  2. 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 groups in NCT05830682
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants 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 GroupNo interventionParticipants 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.

  1. 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

  2. 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.

  1. First posted26 Apr 2023
  2. Study start29 Jan 2019
  3. Primary completion29 Jul 2019
  4. Study completion29 Jul 2019

Resources

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)
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

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.

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