NCT04730141

Brief Summary

The aim of this study is to determine the effect of early mobilization protocol on patients' mobilization status and patient care outcomes in patients who undergo major abdominal surgery. This study is a prospective non-randomized controlled clinical trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

January 22, 2021

Last Update Submit

January 28, 2021

Conditions

Keywords

surgery and mobilizationearly mobilization protocol

Outcome Measures

Primary Outcomes (3)

  • The effect of mobilization protocol on mobilization start time

    In the postoperative period, the hour of mobilization of the patient was recorded.The group in which the mobilization protocol was applied and the group in which the mobilization protocol was not applied were compared

    first 24 hours postoperatif

  • Postoperative sleep quality

    VAS is considered a valid, reliable and usable measurement tool used to convert some values that cannot be measured numerically into numericals. Possible scores from 0 (worst case) to 10 (best case)

    Postoperative 24th hour

  • Postoperative patient satisfaction

    VAS is considered a valid, reliable and usable measurement tool used to convert some values that cannot be measured numerically into numericals. Possible scores from 0 (worst case) to 10 (best case)

    Postoperative 24th hour

Secondary Outcomes (1)

  • Postoperative number of steps

    The total number of steps taken during the first 24 hours postoperatively

Study Arms (2)

mobilization protocol

EXPERIMENTAL

The early mobilization protocol developed by using up-to-date guidelines and expert opinions were applied to the patients in the intervention group.

Other: Patient mobilization with pre-operative mobilization training and mobilization protocol

routine care

NO INTERVENTION

The routine mobilization follow-up approach of the intensive care unit was applied to the patients in the control group .

Interventions

Postoperative mobilization for the first 24 hours

mobilization protocol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • To undergo major abdominal open surgery
  • ASA \<IV
  • Being over the age of 18
  • Not having a barrier to communication
  • Having agreed to participate in the study

You may not qualify if:

  • Being diagnosed that may limit mobilization
  • Being diagnosed with chronic obstructive pulmonary disease
  • ASA IV-V-VI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fadime

Ankara, Turkey (Türkiye)

Location

Study Officials

  • Emine Iyiun

    Gulhane Hemsirelik Fakultesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: quasi-experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 29, 2021

Study Start

May 29, 2019

Primary Completion

September 3, 2019

Study Completion

March 27, 2020

Last Updated

January 29, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations