- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06053957
The Effect of Early Mobilization on Postoperative Recovery in Abdominal Surgery
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sivas, Turkey, 58140
- Kubra Erturhan Turk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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