Effect of Mobilization Protocol on Mobilization

January 28, 2021 updated by: Fadime Koyuncu, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Effect of Mobilization Protocol on Mobilization Start Time and Patient Care Results in Patients Undergoing Abdominal Surgery

The aim of this study is to determine the effect of early mobilization protocol on patients' mobilization status and patient care outcomes in patients who undergo major abdominal surgery. This study is a prospective non-randomized controlled clinical trial.

Study Overview

Detailed Description

The study sample consisted of 42 patients, 21 of whom were the control group and 21 were the intervention group, who had undergone major abdominal open surgery between May and September 2019. The routine mobilization follow-up approach of the intensive care unit was applied to the patients in the control group, and the early mobilization protocol developed by using up-to-date guidelines and expert opinions were applied to the patients in the intervention group. In the study, the data of the control group were firstly collected, then the early mobilization protocol was introduced to the patients through the training brochure prepared and then data of the intervention group were collected. In the study, the characteristics of the patients in both groups belonging to the preoperative period, the distance they walked in the 6-minute walking test and the results of the postoperative period were recorded.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • Fadime

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To undergo major abdominal open surgery
  • ASA <IV
  • Being over the age of 18
  • Not having a barrier to communication
  • Having agreed to participate in the study

Exclusion Criteria:

  • Being diagnosed that may limit mobilization
  • Being diagnosed with chronic obstructive pulmonary disease
  • ASA IV-V-VI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mobilization protocol
The early mobilization protocol developed by using up-to-date guidelines and expert opinions were applied to the patients in the intervention group.
Postoperative mobilization for the first 24 hours
No Intervention: routine care
The routine mobilization follow-up approach of the intensive care unit was applied to the patients in the control group .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of mobilization protocol on mobilization start time
Time Frame: first 24 hours postoperatif
In the postoperative period, the hour of mobilization of the patient was recorded.The group in which the mobilization protocol was applied and the group in which the mobilization protocol was not applied were compared
first 24 hours postoperatif
Postoperative sleep quality
Time Frame: Postoperative 24th hour
VAS is considered a valid, reliable and usable measurement tool used to convert some values that cannot be measured numerically into numericals. Possible scores from 0 (worst case) to 10 (best case)
Postoperative 24th hour
Postoperative patient satisfaction
Time Frame: Postoperative 24th hour
VAS is considered a valid, reliable and usable measurement tool used to convert some values that cannot be measured numerically into numericals. Possible scores from 0 (worst case) to 10 (best case)
Postoperative 24th hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative number of steps
Time Frame: The total number of steps taken during the first 24 hours postoperatively
Pedometer programs are easy-to-use mobile applications where features such as the number of steps taken at a given time and walking distance can be recorded. Pedometer application is downloaded to the phone, the number of steps and walking distance are recorded by carrying it in a pocket or bag. In this study, Developer: ITO Technologies Inc, category: health and fitness, version 1.1.10 pedometer program was used.
The total number of steps taken during the first 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Emine Iyiun, Gulhane Hemsirelik Fakultesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2019

Primary Completion (Actual)

September 3, 2019

Study Completion (Actual)

March 27, 2020

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (Actual)

January 29, 2021

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 19208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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