CClinicalTrials.gg
CompletedNCT06385613Updated Mar 12, 2026

The Effect of Mobile-Based Education on Self-Care, Quality of Life and Complications in Patients With Intestinal Stoma

An interventional study of Mobile-based stoma care education group in Intestinal Stoma Site Hemorrhage, Intestinal Stoma Leakage and Life Style, Healthy, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Ataturk University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Stomas are most commonly used in the gastrointestinal tract as ileostomy or colostomy. Although colorectal cancers are the most important factor causing intestinal stoma opening, intestinal ostomies are also used in cases such as congenital anomalies, obstructive or inflammatory bowel diseases, traumas requiring surgery, large defects caused by colorectal injuries as well as sigmoid colon volvulus and ischemic colitis. In stoma surgery performed to increase the duration and quality of life of individuals, the patient's compliance with the stoma and awareness of possible complications are important. Conditions such as peristomal skin problems, noisy bowel movements, stool leakage and pain make it difficult to adapt to the stoma.In addition, despite all the advances in stoma care products and surgical techniques, individuals are faced with stoma complications. Therefore, individuals with stoma should be closely monitored for complications. Inappropriately selected stoma site or bag/adapter system, lack of knowledge and skills related to stoma care can be listed among the possible causes of complications. Complications such as edema, bleeding, ischemia and mucocutaneous separation may develop in the first days after stoma surgery. In studies evaluating patients in terms of stoma compliance and complications in the literature, it has been observed that mobile-based trainings given to patients increase their stoma compliance and reduce the incidence of complications. With the mobile-based training planned to be used in the study, it is thought to contribute to the ability of individuals to perform stoma care independently. With the decrease in peristomal skin lesions and stoma complications, it is predicted that the quality of life of patients with stoma will increase, self-care competence will be formed, and health expenditures and therefore national health expenditures will decrease. It is thought that this mobile training application will not only provide support to patients with stoma but also guide healthcare professionals. It will also contribute to closing the shortage of stoma and wound care nurses in hospitals.

Read the detailed description

There are many factors that make it difficult for individuals to adapt and cope with the stoma. The most important components in the prevention and treatment of complications can be listed as marking the stoma site, evaluation of the peristomal skin, placement and removal of the appropriate bag/adapter system with the correct technique, close monitoring of patients, patient education, and performing medical and surgical interventions. Nursing care; complication management, patient care, nutrition, excretion, family relations, sexuality, sexuality, worship, work life, social life should be carried out by determining the problems related to the areas and paying attention to the privacy areas. In this context, nursing care should include a care process that starts at the time of hospitalization and covers the post-discharge period. Nursing care should aim to diagnose problems, increase stoma compliance and quality of life, physical/psychological recovery and gain stoma care skills.

Easy access to online information presents a dichotomy in terms of risk and benefit. If the patient is unable to assess the quality of the information and its relevance for his/her specific situation, decision-making may be negatively affected, leading to negative outcomes. The benefit of digital communication, especially in the context of individuals with ostomies, is that it provides individuals, families and communities with scientific information about informed practices. This allows the individual to identify and indicate early signs of complications. They can also receive guidance on their problems, contributing to an easier and more appropriate decision-making process. Providing adequate stoma care enables patients to cope better with their stoma and is therefore important for improving their quality of life. Although the importance of stoma care has been reported, it remains inadequate in many aspects. Innovative mobile applications have a significant potential to overcome these shortcomings. self-efficacy and participation in care can be improved by using mobile applications. It has been stated that patients supported by mobile applications are better supported in stoma care and have more self-efficacy, so individuals receiving support will have a good quality of life.In a study conducted in Turkey, it was reported that individuals who used a mobile application had higher levels of stoma compliance, ability to care for the stoma on their own, and satisfaction with the training they received than those who used a printed booklet. However, it was stated that the application was not effective in preventing peristomal skin lesions. It was stated that additional studies are needed to determine which features of a mobile application may be useful in preventing such lesions. For this reason, it is thought that the mobile-based training application to be developed will contribute to the patients to accept and manage the process faster, to have competence in stoma care, and to perform stoma care independently with well-managed care and education.

02

Conditions studied

  • Intestinal Stoma Site Hemorrhage
  • Intestinal Stoma Leakage
  • Life Style, Healthy

Keywords

  • intestinal stoma
  • mobile-based education
  • self-care
  • quality of life
  • complication
03

In context

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Able to understand and speak Turkish,
  • Not visually or hearing impaired,
  • No neurological disease affecting psychiatric or cognitive status,
  • Decision to perform ileostomy or colostomy,
  • No previous experience with intestinal stoma,
  • Patients who can use telephone and internet will be included in the study.

Exclusion criteria

Exclusion Criteria:

  • Don't lose your life
  • Development of a serious complication after surgical intervention
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Control Group

    Patients who have undergone stoma surgery will be divided into two groups as control and intervention by simple randomization. Patients assigned to the control group will receive standard stoma care training applied by the clinic. Patients will be met before surgery and necessary information will be obtained. A total of 5 interviews will be conducted with patients in both groups.

    Behavioral: Mobile-based stoma care education group

  • Experimental
    Mobile-based stoma care education group

    Patients who have undergone stoma surgery will be divided into two groups as control and intervention by simple randomization. Patients assigned to mobile-based stoma care education groupwill receive mobile-based stoma care training prepared by the researcher. Patients will be met before surgery and necessary information will be obtained. A total of 5 interviews will be conducted with patients in both groups.

    Behavioral: Mobile-based stoma care education group

Interventions

  • BehavioralMobile-based stoma care education group

    Individuals included in the intervention group will be given mobile-based stoma care trainings before surgery, on the 3rd postoperative day, on the day of discharge, and on the 1st and 3rd months after discharge, and their effectiveness will be measured using data collection forms.

06

What researchers measure

Primary outcomes

  1. Adaptation of Quality Life Scale

    Patients' quality of life with stoma will be evaluated.The scale consists of 21 items developed by Baxter et al. in 2006. The Turkish validity and reliability study of the scale was conducted by Karadağ, Öztürk and Çelik in 2011. The first two items of the scale score an individual's general satisfaction with his/her life between ''0'' and ''100'' (0 indicates complete dissatisfaction, 100 indicates complete satisfaction). The other items are grouped into three sub-dimensions. These dimensions are work/social life, sexuality/body image and stoma function, respectively. The scale also includes 1 item on economic status and 1 item on skin irritation, which are not included in any sub-dimension. Except for the first two items of the scale, the other 19 items are in the form of 5-point Likert scale as 1: never, 2: rarely, 3: occasionally, 4: often, and 5: always. Each sub-dimension is evaluated out of 100 points (0 indicates poor quality of life, 100 indicates good quality of life).

    Time frame: Average 3 months after completion of stoma care education.

  2. Ostomy Self-Care Index

    The "Ostomy Self-Care Index" scale was developed by Giulia Villa et al. in 2019 to measure the self-care of patients with stoma. The Turkish validity and reliability of the scale was conducted by Avcu and Yıldız in 2022. The "Ostomy Self-Care Index" scale consists of 32 items and 4 subsections. According to the internal consistency method used in the development phase of the "Ostomy Self-Care Index" scale, Cronbach's alpha value was found to be 0.965 for the sub-scales, 0.965 for "Self-Care Maintenance", 0.953 for "Self-Care Monitoring", 0.930 for "Self-Care Management", 0.962 for "Self-Care Confidence" and 0.975 for the total. As a result of the factor analysis, "Self-Care Monitoring" and "Self-Care Confidence" sub-dimensions were grouped under a single factor.

    Time frame: Average 3 months after completion of stoma care education.

  3. Pittman Ostomy Complication Severity Index

    Stoma complications experienced by patients with stoma will be evaluated. The scale was developed by Pittman et al. 2014 to assess the severity of ostomy complications in the postoperative period. The Turkish validity and reliability of the scale was conducted by Aslantaş et al. in 2020. Each item of the Likert-type scale consisting of 9 items is evaluated in the range of 0-3 points. Each item includes one of the stoma complications: leakage, peristomal irritant dermatitis, pain, bleeding, stomal necrosis, stomal stenosis, retraction, mucocutaneous separation and hyperplasia. A score of ''0'' indicates no complications and ''3'' indicates very serious complications. The total score for all items is a minimum of ''0'' and a maximum of ''27''. The highest total score indicates a very serious complication. The scale has no sub-dimensions.

    Time frame: Average 3 months after completion of stoma care education.

  4. Peristomal Skin Tool

    The peristomal skin tool was developed in 2009 with the collaboration of 12 expert stoma care nurses from different countries, dermatologist recommendations and the support of Coloplast A.Ş. (Humlebaek, Denmark). The tool consists of two parts; Color change, Erosion, Uncontrolled tissue growth score calculation guide and Assessment, Intervention, Monitoring guide. The validity and reliability of the tool in our country was conducted by Harputlu and Özsoy in 2016. The intraobserver agreement coefficient of the peristomal skin tool was reported to be very good (0.83-1) and the interobserver agreement coefficient was reported to be moderate to good (0.51-0.77).

    Time frame: Average 3 months after completion of stoma care education.

  5. Ostomy Adjustment Inventory-23

    It is a 23-item self-assessment scale developed by Simmons et al. to determine the level of stoma adaptation of individuals with stoma. The Turkish validity and reliability of the scale was conducted by Karadağ et al. in 2011. The 23-item self-report scale consists of 4 sub-factors including acceptance (items 1, 3, 4, 6, 9, 14, 15, 19, 23), anxiety/worry (items 12, 13, 17, 20, 21), social adjustment (items 5, 7, 8, 11) and anger (items 2 and 10). In addition, 3 items (16, 18 and 22) were not included in any sub-factor. Each item in the scale is evaluated on a 5-point Likert scale (0-4 points; Strongly agree, Agree, Not sure, Disagree, Strongly disagree) and the higher score obtained from each item indicates an increase in compliance. Twelve items in the scale (items 2, 5, 7, 8, 10, 11, 12, 12, 13, 16, 17, 18 and 21) are reverse scored because they contain negative statements.

    Time frame: Average 3 months after completion of stoma care education.

  6. Computer System Usability Questionnaire

    The scale will be used to determine the ability of patients receiving mobile-based stoma education to use the educational content. "Computer System Usability Questionnaire was developed by Lewis in 1995. The Turkish validity and reliability of the questionnaire was conducted by Erdinç and Lewis in 2013. The questionnaire categorizes the usability of a computer system into the dimensions of system usefulness, information quality and interface quality. The Turkish form is a short version of the questionnaire and consists of 13 items. Each item is scored from 1 (Strongly agree) to 7 (Strongly disagree). Alpha correlation coefficients of the Turkish version of the scale were calculated between 0.73 and 0.92.

    Time frame: Average 3 months after completion of stoma care education.

07

Study locations

1 site
  • Ataturk University Faculty of Nursing
    Erzurum, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 29607805 ↗
  • Azer SA, AlKhawajah NM, Alshamlan YA. Critical evaluation of YouTube videos on colostomy and ileostomy: Can these videos be used as learning resources? Patient Educ Couns. 2022 Feb;105(2):383-389. doi: 10.1016/j.pec.2021.05.023. Epub 2021 May 18. PubMed 34045092 ↗
  • Azodo, Clement C., and Vivian O. Omuemu. 2017. "Perception of Spirituality, Spiritual Care, and Barriers to the Provision of Spiritual Care among Undergraduate Nurses in the University of Lagos, Nigeria." Journal of Clinical Sciences 14(1):119-25. doi: 10.4103/jcls.jcls.
  • Capilla-Diaz C, Bonill-de Las Nieves C, Hernandez-Zambrano SM, Montoya-Juarez R, Morales-Asencio JM, Perez-Marfil MN, Hueso-Montoro C. Living With an Intestinal Stoma: A Qualitative Systematic Review. Qual Health Res. 2019 Jul;29(9):1255-1265. doi: 10.1177/1049732318820933. Epub 2019 Jan 25. PubMed 30678525 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06385613
Lead sponsor
Ataturk University
Responsible party
Nilgun Soylemez (Lecturer, Ataturk University) — Principal investigator
First posted
Apr 26, 2024
Start date
Nov 1, 2024
Primary completion
May 30, 2025
Completion
Oct 28, 2025
Last update
Mar 12, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion