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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06053957
Other study ID # CumhuriyetTURK01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 16, 2023
Est. completion date February 29, 2024

Study information

Verified date September 2023
Source Cumhuriyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 130
Est. completion date February 29, 2024
Est. primary completion date January 29, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
early mobilization
early mobilization program

Locations

Country Name City State
Turkey Kubra Erturhan Turk Sivas

Sponsors (1)

Lead Sponsor Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The time to start the first mobilization The time of the first mobilization within the first 24 hours after the surgery will be recorded.
Primary Postoperative recovery index results The postoperative recovery index will be applied at the 24th hour.
Primary Total mobilization time in the first 24 hours Total mobilization time will be applied at the 24th hour.
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