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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05809661
Other study ID # 19862023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2021

Study information

Verified date March 2023
Source Kilis 7 Aralik University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study was conducted as a randomized controlled intervention study with repetitive measurements in a pretest-posttest order to examine the effect of nurse navigation program on compliance, quality of life and prevention of complications in patients with intestinal stoma. The study was completed with 30 experimental and 28 control group patients with intestinal stoma in six hospitals, two of which are training and research hospitals, located in Gaziantep city center, between January 1 and December 31, 2021. While counseling, remote support, written and visual trainings, informative messages, phone calls, and appointment scheduling were applied to the patients in the experimental group within the scope of the nurse navigation program, the patients in the control group received standard care


Description:

This study was conducted as a randomized controlled intervention study with repetitive measurements in a pretest-posttest order to examine the effect of nurse navigation program on compliance, quality of life and prevention of complications in patients with intestinal stoma. The study was completed with 30 experimental and 28 control group patients with intestinal stoma in six hospitals, two of which are training and research hospitals, located in Gaziantep city center, between January 1 and December 31, 2021. While counseling, remote support, written and visual trainings, informative messages, phone calls, and appointment scheduling were applied to the patients in the experimental group within the scope of the nurse navigation program, the patients in the control group received standard care. The patients were evaluated using the Patient Information Form, Stoma Complications Evaluation Form, Stoma-Related Problems Experienced Form, Ostomy Compliance Scale, and Stoma Quality of Life Scale at the first interview, at the third and sixth months.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:with intestinal stoma - Having no mental handicap or perception problems and no communication difficulties - No psychiatric disease - 18 years old and over - literate - Capable of using a smartphone - No vision and hearing problems - Those who have the physical ability to change the stoma bag themselves. - Patients with intestinal stoma for a maximum of two months were included in the study. Exclusion Criteria: - After agreeing to participate in the research, wanting to leave, - Those who died during the research process, - The stoma was closed during the research process, - Patients whose communication could not be maintained during the research process

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
implementation of the nurse navigation program
Adult patients with intestinal stoma were contacted continuously for 6 months.

Locations

Country Name City State
Turkey Kilis 7 Aralik Üniversitesi Kilis

Sponsors (1)

Lead Sponsor Collaborator
Kilis 7 Aralik University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary stoma compliance stoma compliance scale 6 month
Secondary life quality quality of life scale 6 month
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