The Effect of Web-Based Patient Education on Quality of Life of Patients With Colostomy and Ileostomy

Not Applicable

Completed

• Conditions: Web Based Patient Education; Quality of Life; Ostomy

• Registration Number: NCT04561674
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

The purpose of the study is to develop, implement and determine the effects of web-based education programs for patients undergoing colostomy and ileostomy.The study is a randomized controlled experimental research with a pre-test post-test control group design. The study group of the research consisted of individuals, who have an abdominal stoma procedure at a Training and Research Hospital operating under the Ministry of Health in Turkey. 35 individuals were enrolled to the experiment and control groups (N=70). The study group of the hospital was determined as a result of the power analysis performed on an average number of 150 patients, on whom a stoma is opened within a year, with an estimated effect rate of 0.824 and a SD of 0.45, the power being 0.80 and confidence interval p:0.05, as a total of 50 patients, 25 in the experiment group and 25 in the control group. Taking into consideration the data loss that may be experienced, it was planned to enrol 35 individuals to the experiment group and 35 individuals to the control group. The patients were randomly assigned to each group. Homogeneity of patients randomized to the experiment and control groups was checked with a t-test. Research data were collected using an Information Form, Stoma Complications Assessment Form and City of Hope-Quality of Life-Ostomy Questionnaire and Stoma Care Knowledge Assessment Test.

Detailed Description

The purpose of the study is to develop, implement and determine the effects of web-based education programs for patients undergoing colostomy and ileostomy.

The study is a randomized controlled experimental research with a pre-test post-test control group design. The study group of the research consisted of individuals, who have an abdominal stoma procedure at a Training and Research Hospital operating under the Ministry of Health in Turkey. 35 individuals were enrolled to the experiment and control groups (N=70). The study group of the hospital was determined as a result of the power analysis performed on an average number of 150 patients, on whom a stoma is opened within a year, with an estimated effect rate of 0.824 and a SD of 0.45, the power being 0.80 and confidence interval p:0.05, as a total of 50 patients, 25 in the experiment group and 25 in the control group. Taking into consideration the data loss that may be experienced, it was planned to enrol 35 individuals to the experiment group and 35 individuals to the control group. The patients were randomly assigned to each group. Homogeneity of patients randomized to the experiment and control groups was checked with a t-test. The stages of the research design were determined completely in accordance with the CONSORT diagram. Data were collected using an Information Form, Stoma Complications Assessment Form and City of Hope-Quality of Life-Ostomy Questionnaire and Stoma Care Knowledge Assessment Test. The study data were analysed with average, standard deviation, frequency, student t test, paired sample t test, variance analysis, Fisher's exact chi-square test, Fisher-Freeman-Halton test and Yates continuity correction test. Significance was assessed at a level of p\<0.05.

Study Timeline

• Study Start: 2017-12-18
• Primary Completion: 2018-02-10
• Study Completion: 2018-05-10
• Study First Submitted: 2020-08-27
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-19
• Last Update Submitted: 2020-09-19
• Study First Posted: 2020-09-23
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Colostomy and ileostomy patients,

• eighteen years and over
• literate
• able to communicate
• who can use computers and internet themselves or their caregivers

Exclusion Criteria

• under eighteen years
• illiterate
• unable to communicate
• who cannot use computers and the internet themselves or their caregivers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of life level	Change from quality of life level at one month	The City of Hope-Quality of Life-Ostomy Questionnaire was applied to the patients in the experimental."City of Hope-Quality of Life-Ostomy Questionnaire (COH-QOL-OQ)" designed and developed by City of Hope Pain and Palliative Care Resource Centre was first created in 1995 under the name "Quality of life in Cancer Patients".

Secondary Outcome Measures

Name	Time	Method
Stoma Care Knowledge Level	Change from stoma care knowledge level at one day	Stoma Care Knowledge Assessment Test was applied to the patients in the experimental group.This was prepared in light of the literature in order to assess the patients' level of knowledge on stoma. There are 17 items in the test. An example question is given below: The stool coming out of the stoma causes irritation on the skin surrounding it. The options are true, false and I do not know.

Trial Locations

Locations (1)

Saglik Bilimleri Universitesi; 🇹🇷 Üsküdar, Istanbul, Turkey