NCT06053957

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

September 17, 2023

Last Update Submit

May 31, 2024

Conditions

Keywords

Early ambulationabdominal surgerynursingpostoperative recovery

Outcome Measures

Primary Outcomes (3)

  • The time to start the first mobilization

    The time of the first mobilization within the first 24 hours after the surgery will be recorded.

  • Postoperative recovery index results

    The postoperative recovery index will be applied at the 24th hour.

  • Total mobilization time in the first 24 hours

    Total mobilization time will be applied at the 24th hour.

Study Arms (2)

Mobilization

EXPERIMENTAL

Patients undergoing early mobilization program

Procedure: early mobilization

mobilization free

NO INTERVENTION

Patients not subjected to early mobilization program

Interventions

early mobilization program

Mobilization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kubra Erturhan Turk

Sivas, 58140, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Early Ambulation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof

Study Record Dates

First Submitted

September 17, 2023

First Posted

September 26, 2023

Study Start

September 16, 2023

Primary Completion

January 29, 2024

Study Completion

February 29, 2024

Last Updated

June 4, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations