The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma

September 5, 2022 updated by: Edanur Ozkaya, Ankara University

The Effect of Education Via Video Conferencing at Home on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma

The aim of this study is to determine the effect of stoma care training given at home via videoconferencing after discharge on the self-efficacy and compliance with stoma of individuals with stoma. In addition to the main purpose, it is aimed to determine whether stoma care education given via video conference at home has an effect on individuals with stoma to perform their own stoma care.

Study Overview

Detailed Description

After discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the Association of Wound Ostomy Incontinence Nurses and video conference in four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. Individuals with stoma in the control group received the training routinely given in the hospital. Self-efficacy and compliance with stoma were measured at baseline and at 2 months. The ability to care for one's own stoma was evaluated at the end of the study.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Denizli
      • Pamukkale, Denizli, Turkey, 06230
        • Edanur Özkaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Opening stoma for the first time,
  • Stoma opening surgery Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, 3rd Floor Surgical Oncology Clinic,
  • Whether the opened stoma is a colostomy or an ileostomy,
  • Able to speak and understand Turkish,
  • be over 18 years old,
  • Not having any mental problems that prevent them from being trained and practiced on stoma care,
  • Not having an obstacle to performing stoma care on their own in terms of vision, hearing and motor skills,
  • Possibility of meeting via video conference,
  • He voluntarily agrees to participate in the research.

Exclusion Criteria:

  • Previous stoma opening experience,
  • Not being discharged within 10 days after the operation,
  • Refusal to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
After discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the Association of Wound Ostomy Incontinence Nurses and video conference in four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month.
Educational booklets are given according to the type of stoma. The individual with the stoma was told that the researcher was always reachable by phone and could communicate if he had any problems. The individuals with stoma in the experimental group received the training of the company representative that sells stoma materials, which is routinely given in the hospital. After discharge, training was given by the researcher via video conference in a total of four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. A post-test was conducted at the end of the 4th training interview, which was administered via video conferencing.
No Intervention: Control Group
Individuals with stoma in the control group received the training of the company representative that sells stoma materials routinely in the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in the self-efficacy of the experimental group according to the Stoma Self-Efficacy Scale scores at the end of the second month
Time Frame: Baseline, 2nd month
The Stoma Self-Efficacy Scale was developed to measure self-efficacy in individuals with stoma. The scale was developed by Bekkers et al. (1996). It is a 22-item scale with two sub-dimensions. Items in this scale are in 5-point Likert type. The first sub-dimension is the "Stoma Care Self-Efficacy" sub-dimension, which consists of the first 13 items. The second sub-dimension is the "Social Self-Efficacy" sub-dimension consisting of the remaining nine items. The minimum score that can be taken from the scale is 22, the maximum score is 110, and an increase in the score from the scale indicates high levels of self-efficacy. There is no reverse scored item in the scale.
Baseline, 2nd month
The change in the adaptation of the experimental group according to the Ostomy Adjustment Inventory-23 scores at the end of the second month
Time Frame: Baseline, 2nd month
It was created by Maekawa (2000) and later this scale was arranged by Simmons et al. (2009) in the form of Ostomy Adjustment Scale-23, consisting of 23 items and 4 sub-dimensions. OAS-23, a self-assessment scale, is a scale used to evaluate the level of adjustment in individuals with stoma. 4 sub-dimensions in this scale: accepting (includes items 1, 3, 4, 6, 9, 14, 15, 19, 23.), anxiety/worry (12, 13, 17, 20, 21 items) .), social cohesion (includes items 5, 7, 8, 11), and anger (includes items 2 and 10). At the same time, there are 3 items (16, 18 and 22) that are not included in any sub-dimensions. Each item of the scale is evaluated in a 5-point Likert type.
Baseline, 2nd month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in the ability of individuals with stoma to care for their stoma at the end of the 2nd month
Time Frame: Baseline, 2nd month
After the individuals with stoma in the experimental group were trained by the researcher throughout the study, it was evaluated that they could or could not perform their own stoma care under the supervision of the researcher. However, the status of individuals in the control group for maintaining stoma care is based on their own statements.
Baseline, 2nd month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Deniz HARPUTLU, PhD, RN, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

September 5, 2022

First Submitted That Met QC Criteria

September 5, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected IPD will share.

IPD Sharing Time Frame

starting 1 months after publication

IPD Sharing Access Criteria

all people access

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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