The Effect of Early Mobilization on Postoperative Recovery in Abdominal Surgery

May 31, 2024 updated by: Kubra Erturhan Turk, Cumhuriyet University

The Effect of Early Mobilization on Postoperative Recovery in Abdominal Surgery: A Randomized Controlled Study

Objectives: This study will be conducted to determine the effect of early mobilization on postoperative recovery in abdominal surgery patients..

Methods: This research is a randomized controlled experimental study. In the Gastrointestinal Surgery Department, a total of 130 patients will be included, consisting of 65 experimental group and 65 control group, who are scheduled for abdominal surgery in the study. In the study, data will be collected using a survey form, Numerical Rating Scale, gradual mobilization chart in the first 24 hours after surgery, and Postoperative Recovery Index (PoRI-TR). On the day before the surgery, the experimental group will receive early mobilization training. On the day of the surgery, vital signs, oxygen saturation, and pain intensity will be assessed before the first mobilization. Pain control will be ensured before mobilization. Each mobilization will be carried out in accordance with the gradual mobilization schedule within the first 24 hours after surgery. Following the Enhanced Recovery After Surgery (ERAS) protocol recommendation, mobilization will be provided outside of bed for a total of 2 hours, with durations increasing by the hour on the day of surgery under the supervision of the researcher: 5, 15, 25, 35, and 40 minutes. Mobilizations for patients showing signs of orthostatic hypotension will be postponed by 30 minutes. On the days following the surgery, patients will be informed to spend 6 hours outside of bed. The control group will receive routine care procedures. The second part of the questionnaire will be administered on the day of the surgery for both the experimental and control groups, and the PoRI-TR will be applied at the 25th hour after surgery. Data will be collected through face-to-face interviews within 20-25 minutes. The data obtained from the research will be evaluated using the SPSS 22.00 program. The normality of the data will be determined by Skewness-Kurtosis tests. Based on this result, either parametric or non-parametric tests will be applied.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

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

      • Sivas, Turkey, 58140
        • Kubra Erturhan Turk

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:

  • Patients who are conscious,
  • Without cognitive or mental problems,
  • Undergoing elective abdominal surgery,
  • Aged 18 and above,
  • Without physical limitations preventing early mobilization,
  • Without active bleeding,
  • Without cardiovascular or respiratory diseases,
  • Classified as American Society of Anesthesiologists (ASA) class I or II,
  • Literate patients
  • Volunteering

Exclusion criteria:

  • Patients undergoing oncologic surgery who spend the first 24 hours in the intensive care unit due to post-operative care,
  • Emergency surgery patients due to the absence of pre-operative preparation phase,
  • Patients who are healthcare workers due to their knowledge about early mobilization

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobilization
Patients undergoing early mobilization program
early mobilization program
No Intervention: mobilization free
Patients not subjected to early mobilization program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time to start the first mobilization
Time Frame: The time of the first mobilization within the first 24 hours after the surgery will be recorded.
The time of the first mobilization within the first 24 hours after the surgery will be recorded.
Postoperative recovery index results
Time Frame: The postoperative recovery index will be applied at the 24th hour.
The postoperative recovery index will be applied at the 24th hour.
Total mobilization time in the first 24 hours
Time Frame: Total mobilization time will be applied at the 24th hour.
Total mobilization time will be applied at the 24th hour.

Collaborators and Investigators

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

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)

September 16, 2023

Primary Completion (Actual)

January 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

September 17, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CumhuriyetTURK01

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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