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Clinical Trials/NCT04561674
NCT04561674
Completed
N/A

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

Saglik Bilimleri Universitesi1 site in 1 country70 target enrollmentDecember 18, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Web Based Patient Education
Sponsor
Saglik Bilimleri Universitesi
Enrollment
70
Locations
1
Primary Endpoint
Quality of life level
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 18, 2017
End Date
May 10, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hacer Ozel

Assistant Professor

Saglik Bilimleri Universitesi

Eligibility Criteria

Inclusion Criteria

  • Colostomy and ileostomy patients,
  • eighteen years and over
  • 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

Outcomes

Primary Outcomes

Quality of life level

Time Frame: 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 Outcomes

  • Stoma Care Knowledge Level(Change from stoma care knowledge level at one day)

Study Sites (1)

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