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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04730141
Other study ID # 19208
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 29, 2019
Est. completion date March 27, 2020

Study information

Verified date January 2021
Source Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The study sample consisted of 42 patients, 21 of whom were the control group and 21 were the intervention group, who had undergone major abdominal open surgery between May and September 2019. The routine mobilization follow-up approach of the intensive care unit was applied to the patients in the control group, and the early mobilization protocol developed by using up-to-date guidelines and expert opinions were applied to the patients in the intervention group. In the study, the data of the control group were firstly collected, then the early mobilization protocol was introduced to the patients through the training brochure prepared and then data of the intervention group were collected. In the study, the characteristics of the patients in both groups belonging to the preoperative period, the distance they walked in the 6-minute walking test and the results of the postoperative period were recorded.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date March 27, 2020
Est. primary completion date September 3, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Being diagnosed that may limit mobilization - Being diagnosed with chronic obstructive pulmonary disease - ASA IV-V-VI

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Patient mobilization with pre-operative mobilization training and mobilization protocol
Postoperative mobilization for the first 24 hours

Locations

Country Name City State
Turkey Fadime Ankara

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Postoperative number of steps Pedometer programs are easy-to-use mobile applications where features such as the number of steps taken at a given time and walking distance can be recorded. Pedometer application is downloaded to the phone, the number of steps and walking distance are recorded by carrying it in a pocket or bag. In this study, Developer: ITO Technologies Inc, category: health and fitness, version 1.1.10 pedometer program was used. The total number of steps taken during the first 24 hours postoperatively
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