Intestinal Stoma Site HemorrhageNCT06385613
The Effect of Mobile-Based Education on Self-Care, Quality of Life and Complications in Patients With Intestinal Stoma
A study testing Mobile-based stoma care education group in people with Intestinal Stoma Site Hemorrhage and Intestinal Stoma Leakage, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Stoma Site Hemorrhage, Intestinal Stoma Leakage, Life Style, Healthy
- What is being tested?
- Mobile-based stoma care education group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 28 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Don't lose your life
- Development of a serious complication after surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Mobile-based stoma care education group
- Keywords
- intestinal stoma, mobile-based education, self-care, quality of life, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile-based stoma care education groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | 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. Receives: Behavioral: Mobile-based stoma care education group |
| Mobile-based stoma care education group | Experimental | 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. Receives: Behavioral: Mobile-based stoma care education group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Average 3 months after completion of stoma care education.
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.
Measured: Average 3 months after completion of stoma care education.
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.
Measured: Average 3 months after completion of stoma care education.
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).
Measured: Average 3 months after completion of stoma care education.
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.
Measured: Average 3 months after completion of stoma care education.
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.
Measured: Average 3 months after completion of stoma care education.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Nov 2024
- Primary completion30 May 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intestinal Stoma Site HemorrhageStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Model description
- Groups will be divided into control and intervention. People in the group will be randomly assigned in a simple randomized manner.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgun Soylemez, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385613
- Sponsor's protocol ID
- TDK-2024-13377
- Status last verified
- Mar 2026
- First submitted
- 19 Apr 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 29607805Azer 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 34045092Azodo, 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile-Based Education on Self-Care, Quality of Life and Complications in Patients With Intestinal Stoma
- ClinicalTrials.gov ID
- NCT06385613
- Acronym / sponsor ID
- TDK-2024-13377
- Keywords
- intestinal stoma, mobile-based education, self-care, quality of life, complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Groups will be divided into control and intervention. People in the group will be randomly assigned in a simple randomized manner.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Behavioral: Mobile-based stoma care education groupPatients 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. |
| Mobile-based stoma care education group | Experimental | Behavioral: Mobile-based stoma care education groupPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- Don't lose your life
- Development of a serious complication after surgical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile-based stoma care education groupIndividuals 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. | Behavioural | Control Group, Mobile-based stoma care education group |
Primary outcome
Adaptation of Quality Life Scale
Time frame: Average 3 months after completion of stoma care education.
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).
Ostomy Self-Care Index
Time frame: Average 3 months after completion of stoma care education.
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.
Pittman Ostomy Complication Severity Index
Time frame: Average 3 months after completion of stoma care education.
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.
Peristomal Skin Tool
Time frame: Average 3 months after completion of stoma care education.
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).
Ostomy Adjustment Inventory-23
Time frame: Average 3 months after completion of stoma care education.
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.
Computer System Usability Questionnaire
Time frame: Average 3 months after completion of stoma care education.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 29607805Ambe 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.
- Background: PubMed 34045092Azer 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.
- BackgroundAzodo, 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.
- Background: PubMed 30678525Capilla-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.
- Individual participant dataSharing planned: No
Related trials for Intestinal Stoma Site Hemorrhage
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile-based stoma care education group in people with Intestinal Stoma Site Hemorrhage and Intestinal Stoma Leakage, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adaptation of Quality Life Scale (time frame: Average 3 months after completion of stoma care education.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06385613, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.