- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04730141
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
Status
Completed
Conditions
Intervention / Treatment
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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