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

NCT ID: NCT04561674

Last Updated: 2020-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2018-05-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Web Based Patient Education Quality of Life Ostomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a randomized controlled experimental research with a pre-test post-test control group design
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

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.

Group Type EXPERIMENTAL

Implementation of web-based patient education

Intervention Type OTHER

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

Control group

The clinical routine was applied to the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implementation of web-based patient education

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role collaborator

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hacer Ozel

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Saglik Bilimleri Universitesi

Üsküdar, Istanbul, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24161637 (View on PubMed)

Ambe PC, Kurz NR, Nitschke C, Odeh SF, Moslein G, Zirngibl H. Intestinal Ostomy. Dtsch Arztebl Int. 2018 Mar 16;115(11):182-187. doi: 10.3238/arztebl.2018.0182.

Reference Type BACKGROUND
PMID: 29607805 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25531238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15361633 (View on PubMed)

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. doi: 10.1023/A:1016369114780.

Reference Type BACKGROUND
PMID: 12188054 (View on PubMed)

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. doi: 10.1080/10810730500526794.

Reference Type BACKGROUND
PMID: 16537289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19502896 (View on PubMed)

Ozel H, Kaya H. The Effect of Web-Based Patient Education on Quality of Life of Patients With Colostomy and Ileostomy: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2025 Jul-Aug 01;52(4):313-319. doi: 10.1097/WON.0000000000001198. Epub 2025 Jul 24.

Reference Type DERIVED
PMID: 40717260 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

31701

Identifier Type: OTHER

Identifier Source: secondary_id

59491012-604.01.02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Flipped Learning Model on the Stoma Care
NCT06397534 NOT_YET_RECRUITING NA