The Effect of Early Mobilization Training on Mobility, Pain and Comfort After Abdominal Surgery

August 27, 2024 updated by: Sevinç Taştan, Eastern Mediterranean University
The primary aim of this study is to examine the effects of in-bed rotation and early mobilization training given before abdominal surgery on mobility, pain and comfort of patients after surgery. The secondary aim of the study is to examine the effect of mobilization training given before abdominal surgery on the sleep of patients after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this clinical trial study is to examine the effects of early mobilization training given before abdominal surgery on mobility, pain and comfort of patients after surgery. The secondary aim of the study is to examine the effect of mobilization training given before abdominal surgery on the sleep of patients after surgery. Research Hypotheses are:

H11. There is a difference between the mobility scores of the patients who were given and not given pre-abdominal surgery training.

H12. There is a difference between the comfort scores of patients who were given and not given pre-abdominal surgery training.

H13. There is a difference between the sleep scores of the patients who were given and not given pre-abdominal surgery training.

First, the patient's mobility status in the preoperative period was evaluated with these scales. "Early Mobilization Training" will be given to the patients in the intervention group in the preoperative period. "Early Mobilization Training Material" to be prepared by the researcher will be used as training material. The training content will include information about the techniques and points to be considered about turning from one side to the other in the bed, sitting on the side of the bed, standing on the side of the bed and walking in the patient's room, and the time spent outside the bed on the day of surgery and the first and subsequent days after surgery.

After the patient's mobilization on the first day after the operation, the Patient Mobility Scale, the Postoperative Mobilization, the Visual Analogue Scale (VAS) questions questioning the pain and comfort during lying and sitting, and sleep status will be filled.

Study Type

Interventional

Enrollment (Actual)

78

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

  • Cyprus
      • Famagusta, Cyprus
        • Eastern Mediterranean University
      • Famagusta, Cyprus, 99450
        • Eastern Mediterranean University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • over 18 years old
  • those with abdominal surgery

Exclusion Criteria:

-

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: early mobilization
Patients in the intervention group will be given "Early Mobilization Training" in the preoperative preparation unit in the preoperative period.
Other: early mobilization
Mobilization training was given to the intervention group.
No Intervention: routine clinical care
Patients in the control group will receive routine clinical care .Routine post-operative mobilization procedure will be delivered by clinic doctors and nurses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Mobility Scale
Time Frame: Change in Baseline Patient mobility score at two days

he level of pain and difficulty experienced during the 4 post-surgical activities (turning from one side of the bed to the other, sitting by the bed, standing up at the bedside, and walking in the patient's room) is evaluated using a 15 cm visual analog with verbal expressions listed at the bottom along the scale.

The numerical value of the degree of pain and difficulty is determined by measuring the distance between the mark on the scale and "0" with a calibrated ruler. An increase in scores indicates an increase in pain and difficulty related to activity. The scores obtained give the patient's mobility score for each activity. The average score value is calculated. Scores for all activities are added together to obtain the global patient mobility score. The total score that can be obtained from the scale varies between 0-120.
Change in Baseline Patient mobility score at two days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain level
Time Frame: Change in Baseline Patient pain score at two days
Preoperative and postoperative pain levels of the patients will be measured with the Visual Anolog Scale for pain.The Visual Analog Scale is a self-reported based measurement tool that is often used to measure subjective experiences pain. In this study, Visual Analog Scale for pain was used to make a numerical definition of a participant's pain levels with the participants' self-reports. Numbers between 0-10 were defined on a line, and the participants were asked to indicate the number of pain intensity levels they feel on this line. Participants with no pain scored 0 and extremely pain participants scored 10.
Change in Baseline Patient pain score at two days
comfort level in bed and while sitting
Time Frame: Change in Baseline comfort score at two days
The comfort level of the patients while turning and sitting in bed will be measured with the Visual Analog Scale for Comfort. In this study, Visual Analog Scale for comfort was used to make a numerical definition of a participant's comfort levels with the participants' self-reports. Numbers between 0-10 were defined on a line, and the participants were asked to indicate the number of comfort intensity levels they feel on this line. Participants with no comfort scored 0 and extremely comfort participants scored 10.
Change in Baseline comfort score at two days

Collaborators and Investigators

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

Sponsor

Eastern Mediterranean University

Investigators

  • Study Director: Sevinc Tastan, Prof., Eastern Mediterranean University, Health Sciences Faculty, Famagusta, North Cyprus,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

February 2, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

November 27, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Actual)

December 20, 2022

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FD_01

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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