MOBILE EDUCATION AND COMFORT IN OSTOMY PATIENTS

NCT07358286 | Not Yet Recruiting DMC

• 1 other identifier: EGEU_PHD_STOMA_2025
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose of the Study This study aims to understand whether a mobile education program can improve comfort levels in people living with a stoma. A stoma is a surgical opening created on the abdomen to allow stool or urine to leave the body. Living with a stoma can affect daily life in many ways, including physical comfort, emotional well-being, social life, and the home environment. The education program used in this study is based on Kolcaba's Comfort Theory. This theory focuses on comfort as a whole and includes physical, emotional, social, and environmental aspects of a person's life. The study will compare people who receive mobile education with those who receive standard hospital care only. Who Can Take Part Adults aged 18 years and older who are scheduled to have colostomy, ileostomy, or urostomy surgery may take part in this study. Participants must be able to communicate in Turkish, read and understand written information, and agree to join the study voluntarily. People with severe cognitive problems, serious communication difficulties, or major vision or hearing problems will not be included. What Will Happen in the Study Participants will be randomly assigned to one of two groups: Mobile Education Group Standard Care Group Both groups will receive routine care provided by the hospital. Participants in the mobile education group will also receive access to a mobile application designed specifically for people with a stoma. This application includes: Easy-to-understand information about stoma care Animated educational videos showing step-by-step stoma care practices Guidance on skin care, pouch changing, and hygiene Information on common problems and when to seek medical help Reminders to support daily stoma care routines The mobile application can be used on smartphones and does not include diagnosis or treatment. It is for education and support only. Participants in the standard care group will receive usual hospital education and care. After the study is completed, they will also be offered the mobile education program. What Participants Will Be Asked to Do All participants will be asked to answer questionnaires that measure comfort levels at several time points: Before surgery One day after surgery Fifteen days after discharge (by phone) One month after surgery (during a clinic visit) Participants in the mobile education group will be shown how to use the application and may use it as often as they wish. Researchers may contact participants to ask about their experience using the app and to identify any difficulties. Possible Benefits Participants may gain better understanding of stoma care and feel more confident managing daily life with a stoma. The mobile education program may help reduce discomfort, support emotional well-being, and improve overall quality of life. The results of this study may help healthcare professionals develop better education tools and support programs for people living with a stoma. Risks and Safety This study does not involve experimental medical treatments. The mobile application provides education only. Personal data will not be collected through the app, and all information will be kept confidential. Participants may leave the study at any time without affecting their medical care. Why This Study Is Important Access to stoma care education can be limited due to time constraints, staff availability, and hospital resources. Mobile education may provide an easy and accessible way for people to receive reliable information whenever they need it. This study will help determine whether a comfort-focused mobile education program can support people living with a stoma and improve their overall comfort and well-being.

Conditions

Stoma; Ostomy; Mobile Application

Keywords

Ostomy Care; Mobile Health; Kolcaba's Comfort Theory; Nursing

Outcome Measures

Primary Outcomes (1)

• Comfort Level of Patients with a Stoma

  The comfort level of patients with a stoma will be measured using the General Comfort Questionnaire developed by Kolcaba. The scale assesses overall comfort across physical, psychospiritual, sociocultural, and environmental dimensions. Total comfort scores will be compared between the intervention and control groups.

  Preoperative period, postoperative day 1, postoperative day 15, and 1 month after surgery

Study Arms (2)

Control Group

NO INTERVENTION

Participants in the control group will receive standard postoperative care only, without the mobile education intervention.

Experimental Group

EXPERIMENTAL

Participants in the experimental group will receive a mobile education program based on Kolcaba's Comfort Theory, including animation-based stoma care education, in addition to standard postoperative care.

Behavioral: Mobile Education Program Based on Kolcaba's Comfort Theory

Interventions

Mobile Education Program Based on Kolcaba's Comfort Theory BEHAVIORAL

The intervention consists of a mobile education program based on Kolcaba's Comfort Theory. The program includes animation-based educational content on stoma care, pouch changing, peristomal skin care, and postoperative self-care. The mobile education is designed to support patients in managing their stoma and to improve their overall comfort levels.

Also known as: The intervention consists of a mobile education program based on Kolcaba's Comfort Theory, including animation-based stoma care education. The program provides information on stoma care, pouch changin

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older
• Patients with a stoma (colostomy or urostomy)
• Ability to use a smartphone or mobile device
• Willingness to participate in the study
• Ability to provide informed consent

You may not qualify if:

• Cognitive impairment that prevents understanding of the study procedures
• Severe psychiatric disorders
• Inability to use mobile technology
• Participation in another interventional study during the study period

Sponsors & Collaborators

• Ege University: lead

Related Publications (4)

• Wang M, Liao W, Chen X. Effects of a Short-term Mindfulness-Based Intervention on Comfort of Stroke Survivors Undergoing Inpatient Rehabilitation. Rehabil Nurs. 2019 Mar/Apr;44(2):78-86. doi: 10.1097/rnj.0000000000000098.

  PMID: 30830883 BACKGROUND

• Hsu, M. Y., et al. (2020). Preoperative stoma site marking decreased stoma and peristomal complications. Journal of Wound Ostomy & Continence Nursing. https://doi.org/10.1097/WON.0000000000000634 Kang, Y., et al. (2025). Life experience of patients living with urostomy: A meta-synthesis. Psycho-Oncology, 34, e70096. https://doi.org/10.1002/pon.70096 Karadağ, A., et al. (2011). Ostomili bireylere yönelik uyum ölçeğinin Türkçeye uyarlanması. Ulusal Cerrahi Dergisi, 27(4), 206-211. Kolcaba, K. (1992). Holistic comfort: Operationalizing the construct as a nurse-sensitive outcome. Advances in Nursing Science, 15(1), 1-10. Kolcaba, K. (2003). Comfort theory and practice: A vision for holistic health care and research. Springer. Kuğuoğlu, S., Karabacak, Ü. (2008). Genel konfor ölçeğinin Türkçe'ye uyarlanması. İ.Ü.F.N. Hemşirelik Dergisi, 16(61), 16-23. Kuzu, M. A., et al. (2002). Effect of sphincter-sacrificing surgery for rectal carcinoma on quality of life. Diseases of the Colon & Rectum, 45(10), 1359-1366. Langer, A., et al. (2021). Digital health and remote interventions. NPJ Parkinson's Disease, 7(1). https://doi.org/10.1038/S41531-021-00160-3 Pinquart, M., Duberstein, P. R. (2010). Depression and cancer mortality: A meta-analysis. Psychological Medicine, 40(11), 1797-1810. Salvadalena, G. (2013). The incidence of stoma and peristomal complications. Journal of Wound, Ostomy and Continence Nursing, 40(4), 400-406. https://doi.org/10.1097/WON.0b013e318295a12b

  BACKGROUND

• Barnwell, A. (2015). Advanced nursing practice in colorectal and stoma care. Gastrointestinal Nursing, 13(1), 42-48. https://doi.org/10.12968/gasn.2015.13.1.42 Brady, R. R. W., et al. (2025). The prevalence of leakage, peristomal skin complications and impact on quality of life in the first year following stoma surgery. Nursing Reports, 15, 107. https://doi.org/10.3390/nursrep15030107 Bulut Özek, M., Gür, D. (2021). Mobil öğrenmenin öğrencilerin akademik başarısı, motivasyonu ve tutumları üzerine etkisi: Bir meta-analiz. Trakya Eğitim Dergisi, 11(1), 1-15. https://doi.org/10.24315/tred.581539 Burch, J. (2015). Examining stoma care guidance for nurses. Gastrointestinal Nursing, 13(6), 17-25. https://doi.org/10.12968/gasn.2015.13.6.17 Çınar Yücel, Ş. (2011). Kolcaba'nın konfor kuramı. Ege Üniversitesi Hemşirelik Yüksekokulu Dergisi, 27(2), 79-88. Duluklu, B., Çelik, S. Ş. (2019). Kolostomisi olan bireylerde yaşam kalitesi: Sorunlar ve hemşirelik girişimleri. HUHEMFAD-JOHUFON, 6(2), 111-119. Goldberg, M., et al. (2018). WOCN Society clinical guideline: Management of the adult patient with a fecal or urinary ostomy. Journal of Wound, Ostomy and Continence Nursing, 45(1), 50-58. https://doi.org/10.1097/WON.0000000000000396 Grant, M., et al. (2013). Development of a chronic care ostomy self-management program. Journal of Cancer Education, 28, 70-78. Gruessner, V. (2015). The advantages of mobile health apps today and tomorrow. https://mhealthintelligence.com

  BACKGROUND

• Akalın, B., Modanlıoğlu, A. (2020). 'Ameliyathane hemşiresi olmak': Nitel bir çalışma. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 23(1), 100-108. Aksoy, G., Çavdar, İ. (2015). Sindirim sistemi (gastrointestinal sistem) stomalarında bakım. In N. Akyolcu & N. Kanan (Eds.), Yara ve Stoma Bakımı (1. Baskı, ss. 67-81). Nobel Tıp Kitapevleri. Aminisani, N., Nikbakht, H., Jafarabadi, M. A., & Shamshirgaran, S. M. (2017). Depression, anxiety, and health-related quality of life among colorectal cancer survivors. Journal of Gastrointestinal Oncology, 8(1), 81-88. https://doi.org/10.21037/jgo.2017.01.12 Ayalon, R., Bachner, Y. G. (2019). Medical, social, and personal factors as correlates of quality of life among older cancer patients with permanent stoma. European Journal of Oncology Nursing, 38, 50-56. https://doi.org/10.1016/j.ejon.2018.11.010 Ayaz, S. (2008). Stomalı bireylerin cinsel sorunlarına yaklaşım. Türkiye Klinikleri Journal of Medical Ethics, 16, 89-93. Ayık, C., Özden, D. (2023). Stoma komplikasyonları ve hemşirelik bakımı: Güncel yaklaşımlar. Etkili Hemşirelik Dergisi, 16(3). Ayık, C., Özden, D., Cenan, D. (2020). Ostomy complications, risk factors, and applied nursing care. Wound Management & Prevention, 66(9), 20-30. https://doi.org/10.25270/wmp.2020.9.2030

  BACKGROUND

Central Study Contacts

Gökçe Nur Taşkıran, PhD Student

CONTACT

+905549064840; gokcenur94@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to group allocation. Participants are not informed about their group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student, Nursing

Model Details: This study is a single-center, randomized, controlled, parallel-group, single-blind intervention study. Participants will be randomly assigned to either an intervention group receiving comfort theory-based mobile education or a control group receiving standard care.

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share