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Effect of Using Walking Aid on Mobility

Primary Purpose

Coronary Artery Bypass Graft Surgery, Pain, Early Mobilization

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
using a walking aid
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Bypass Graft Surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: patients who had a vein other than the saphenous vein grafting whose mobilization was not approved by the physician

Sites / Locations

  • Seher Ünver

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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."
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"

Secondary Outcome Measures

Full Information

First Posted
April 14, 2023
Last Updated
April 27, 2023
Sponsor
Trakya University
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1. Study Identification

Unique Protocol Identification Number
NCT05830682
Brief Title
Effect of Using Walking Aid on Mobility
Official Title
Effect of Using Walking Aid on Pain and Mobility Levels of Patients Underwent CABG Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
July 29, 2019 (Actual)
Study Completion Date
July 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Graft Surgery, Pain, Early Mobilization, Walking, Difficulty

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The observer and data analysed was completed by independent researchers
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
using a walking aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain level
Description
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."
Time Frame
in the intensive care unit on the first postoperative day
Title
Difficulty level
Description
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"
Time Frame
in the intensive care unit on the first postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: patients who had a vein other than the saphenous vein grafting whose mobilization was not approved by the physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seher Ünver
Organizational Affiliation
Trakya University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simge R Aktürk Tuncer
Organizational Affiliation
Çorlu State Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seher Ünver
City
Edirne
ZIP/Postal Code
22030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Using Walking Aid on Mobility

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