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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Web-Based Patient Education on Quality of Life of Patients With Colostomy and Ileostomy: A Randomized Controlled Trial

Conditions
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Ostomy, Web Based Patient Education, Quality of Life

Intervention / Treatment
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* Other: Implementation of web-based patient education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a randomized controlled experimental research with a pre-test post-test control group design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The patients in the experimental group participated in Web-Based Patient Education with Colostomy and Ileostomy on computer between the third and seventh days after surgery. The cards with the website address, username and the website QR code were given to the patients in order to be able to receive education after discharge.The patient and her family received the training from any computer or smartphone connected to the internet. | Other: Implementation of web-based patient education<br>* Web-Based Patient Education on Colostomy and Ileostomy (WBPECI) was developed in accordance with the principles of the ADDIE instructional design. The web-based education was designed in line with these learning objectives determined. The content of the website was developed in light of the opinions sought from five subject experts. The WBPECI content includes a total of 7 videos, 1 animation with sound, 1 forum and 1 consultation page<br>|
| No Intervention: Control group<br>The clinical routine was applied to the control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life level | 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. | Change from quality of life level at one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stoma Care Knowledge Level | 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. | Change from stoma care knowledge level at one day |