The Effect of Mobile Health Education on Adaptation to Stoma, Self-efficacy, and Peristomal Lesions

December 22, 2022 updated by: Eylem Togluk Yigitoglu, Istanbul University

The Effect of Mobile Health Education on Adaptation to Stoma, Self-efficacy, and Peristomal Skin Lesions: A Quasi-experimental Study

To explore the effect of the Stoma Mobile application-based training method on the psychosocial adjustment, self-efficacy, and development of peristomal skin complications in individuals with a stoma.

Quasi-experimental study with a post-test control group. Patients who met the inclusion criteria were randomly selected. While the experimental group (n=30) received training with the Stoma Mobile application, the control group (n=30) received training with the booklet. Stoma compliance, self-efficacy level, and the presence of complications were compared in both groups in the first and third months after discharge.

H11: Individuals who receive stoma care training via STOMA-M will have a higher adaptation to stomas than individuals who receive stoma care training via a booklet.

H12: The SE levels of individuals who receive stoma care training via STOMA-M will be higher than those who receive stoma care training via a booklet.

H13: Peristomal skin complications of individuals who receive stoma care training via STOMA-M will be lower than those who receive stoma care training via a booklet.

The population of the study included patients who had a stoma for the first time, were in a university hospital in Istanbul between December 2020 and December 2021, and who were 18 years of age and older, literate, without any physical and psychological disabilities, able to use smartphones, and willing to participate in the study. Patients who were in the same room or underwent a urostomy were not included in the study.

The experimental group using the Stoma Health Mobile application had higher psychosocial adjustment and self-efficacy scores than the control group, and the peristomal skin lesion complication rate was lower than that of the control group. Social self-efficacy positively affects stoma compliance, and the Stoma Mobile application positively affects the level of social self-efficacy and adaptation of ostomates to the stoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ostomates need to learn to cope with new self-care routines and emotional problems related to changes in body image and self-perception. This learning process is defined as psychosocial adjustment. Adaptation of the patient to the stoma after surgery is part of the process in which the patient re-coordinates the body, self, and external world. In addition to the follow-up process after surgical treatments, psychosocial adjustment is one of the most important factors that define SE and quality of life.

Bandura (1994) defines SE as the belief that people can effectively initiate the necessary activities and reach results in events related to their lives. In other words, SE is a dynamic cognitive process that expresses the confidence of individuals with a stoma in their own ability to be successful in stoma care. SE plays an important role in adapting to the stoma. Not only do individuals who can self-care better adapt to a stoma.

Structured education has an important place in the ability of ostomates to cope with these problems. This training is indispensable, as it helps ostomates cope with physical, psychological, and social difficulties. Face-to-face training given during hospitalization is a traditional and effective method designed to impart new information and self-care behavior. However, it has its limitations. This type of training is time-consuming, and retaining the given information is often difficult for patients, as they experience postoperative anxiety and pain. In addition, the number of ostomy and wound care nurses in Turkey is not sufficient. When ostomates experience a problem with their stoma, they may not be able to contact the ostomy nurse. Considering that stomas are usually applied to cancer patients, their general condition deteriorates due to chemotherapy and radiotherapy. For this reason, it is important that ostomates receive information on living with a stoma in their mobile environment, thus having such information accessible at any time through their smartphones.

The literature contains limited studies comparing the effects of face-to-face/booklet and mobile training on the adaptation, self-efficacy, and peristomal skin complications of ostomates. Accordingly, this study evaluated the effect of the mobile application and booklet training in the education of ostomates on the adaptation and skin complications of ostomates. Thus, the study examined the effect of using innovative, technology-based education approaches in the education of ostomates, offering a significant contribution to the literature and individual-centered care.

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

  • Turkey
      • Istanbul, Turkey
        • Eylem Toğluk Yiğitoğlu

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

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age and older
  • Literate,
  • Without any physical and psychological disabilities,
  • Able to use smartphones
  • Willing to participate in the study.

Exclusion Criteria:

  • Patients who were in the same room or underwent a urostomy were not included 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
No Intervention: Booklet
Control-Classical patient education before the operation, the patient is educated with the classical method brochure.
Experimental: STOMA-M
Patients are educated with the mobil aplikasyon method.
Other: Assigned Interventions STOMA-M
The training, which includes information on stoma care, maintenance of daily life activities, and complication management, was given to the patients in the experimental group via the STOMA-M.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Adjustment Scale for Individuals with Ostomy
Time Frame: Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)
It is a self-assessment scale consisting of 23 items developed by to determine the compliance of individuals with stoma. The scale, which is graded in a five-point Likert type, has four sub-dimensions. These four dimensions are anger, social adaptation, anxiety/worry and acceptance. While the lowest score on the scale is '0', the highest score is '92'
Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stoma Self-Efficacy Scale
Time Frame: Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)
The scale consists of 22 items. The scale, which is graded in a five-point Likert type, consists of two sub-dimensions. Sub-dimensions; Stoma Care is Self-Efficacy and Social Self-Efficac. The possible score on the scale ranges from 22 to 110. The higher the score, the better the level of self-efficacy
Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation Tool for Peristomal Skin Lesions; SACS
Time Frame: Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)

The SACS; The five most common lesions in the SACS (L) are: hyperemic (L1: peristomal redness with intact skin), abrasive (L2: open lesion not extending to subcutaneous tissue; skin loss in partial thickness), ulcerative (L3: open lesion extending to subcutaneous tissue and under the skin; skin loss in full-thickness), ulcerative (L4: skin loss in full-thickness with dead tissue), and proliferative (L5: abnormal growth present; i.e., hyperplasia, granulomas, neoplasms) lesions.

Five topographic (T) quadrants arranged clockwise around the stoma are used to record the location of the peristomal lesion: TI: Left upper peristomal quadrant (between 12-3 o'clock), TII: Left lower peristomal quadrant (between 3-6 o'clock), TIII: Right lower peristomal quadrant (between 6-9 o'clock), TIV: Right upper peristomal quadrant (between 9-12 o'clock), and TV: Refers to all peristomal quadrants.
Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)

Collaborators and Investigators

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

Sponsor

Istanbul 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 18, 2020

Primary Completion (Actual)

December 10, 2020

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Actual)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IstanbulU 2022-07/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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