Quality of Life Clinical Trial
Official title:
The Effect of Web-Based Patient Education on Quality of Life of Patients With Colostomy and Ileostomy: A Randomized Controlled Trial
Verified date | September 2020 |
Source | Saglik Bilimleri Universitesi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | May 10, 2018 |
Est. primary completion date | February 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Saglik Bilimleri Universitesi | Üsküdar | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Saglik Bilimleri Universitesi | Istanbul University-Cerrahpasa |
Turkey,
Ambe PC, Kurz NR, Nitschke C, Odeh SF, Möslein G, Zirngibl H. Intestinal Ostomy. Dtsch Arztebl Int. 2018 Mar 16;115(11):182-187. doi: 10.3238/arztebl.2018.0182. — View Citation
Ang SG, Chen HC, Siah RJ, He HG, Klainin-Yobas P. Stressors relating to patient psychological health following stoma surgery: an integrated literature review. Oncol Nurs Forum. 2013 Nov;40(6):587-94. doi: 10.1188/13.ONF.587-594. Review. — View Citation
Aquina CT, Iannuzzi JC, Probst CP, Kelly KN, Noyes K, Fleming FJ, Monson JR. Parastomal hernia: a growing problem with new solutions. Dig Surg. 2014;31(4-5):366-76. doi: 10.1159/000369279. Epub 2014 Dec 13. Review. — View Citation
Barr JE. Assessment and management of stomal complications: a framework for clinical decision making. Ostomy Wound Manage. 2004 Sep;50(9):50-2, 54, 56 passim. Review. — View Citation
Barrera M Jr, Glasgow RE, McKay HG, Boles SM, Feil EG. Do Internet-based support interventions change perceptions of social support?: An experimental trial of approaches for supporting diabetes self-management. Am J Community Psychol. 2002 Oct;30(5):637-54. — View Citation
Bass SB, Ruzek SB, Gordon TF, Fleisher L, McKeown-Conn N, Moore D. Relationship of Internet health information use with patient behavior and self-efficacy: experiences of newly diagnosed cancer patients who contact the National Cancer Institute's Cancer Information Service. J Health Commun. 2006 Mar;11(2):219-36. — View Citation
Berger J, Topp R, Davis L, Jones J, Stewart L. Comparison of Web-based and face-to-face training concerning patient education within a hospital system. J Nurses Staff Dev. 2009 May-Jun;25(3):127-32; quiz 133-4. doi: 10.1097/NND.0b013e3181a56ba0. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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