Effect of Using Walking Aid on Mobility

NCT05830682 | Completed DMC

• 1 other identifier: 2018/235
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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:

1. 1.The pain level of patients using walking aid is lower than that of those who do not.
2. 2.The mobility level of patients using walking aid is higher than that of those who do not.

Conditions

Coronary Artery Bypass Graft Surgery; Pain; Early Mobilization; Walking, Difficulty

Outcome Measures

Primary Outcomes (2)

• 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."

  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"

  in the intensive care unit on the first postoperative day

Study Arms (2)

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.

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.

Interventions

using a walking aid DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients who had a vein other than the saphenous vein grafting
• whose mobilization was not approved by the physician

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Seher Ünver

Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Mobility Limitation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seher Ünver

  Trakya University

  PRINCIPAL INVESTIGATOR

• Simge R Aktürk Tuncer

  Çorlu State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The observer and data analysed was completed by independent researchers
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: January 29, 2019
• Primary Completion: July 29, 2019
• Study Completion: July 29, 2019
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)