Patient Relations, NurseNCT05308693
Evaluation of the Effect of Two Different Methods on Stoma Compliance and Self-efficacy
A study testing Education material - Patient Compatible Stoma Educational Material in people with Patient Relations, Nurse and Patient Satisfaction, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
In patients with stoma, apart from traditional methods, different methods whşch can be used in visual, auditory and motor skills are recommended as a part of education methods regarding stoma care. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Relations, Nurse, Patient Satisfaction
- What is being tested?
- Education material - Patient Compatible Stoma Educational Material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 19 Jun 2023
- 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
- Adult patients aged 18-85 years
- Patients who have a colostomy or ileostomy for any reason (cancer, ulcerative colitis, chron, hernia, etc.)
- Patients who can speak and understand Turkish and do not have a psychological or neurological disease (Advanced Parkinson's, Alzheimer's, Depression, etc.)
Who cannot join
- Patients with visual and hearing impairment
- Patients that are unable to use their hands and upper extremities (hemiplegic, paraplegic, etc.)
- Patients who requires a revision surgery after surgery
- Patients whose temporary stoma was closed while in the data collection process
- Patients with postoperative complications and prolonged discharge period (evisceration, bleeding, perforation, etc.) will be excluded from the sample.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Two Different Methods in Teaching Stoma Care Skills in Patients With Stoma on Stoma Compliance and Self-efficacy Level of Patients
In patients with stoma, apart from traditional methods, different methods whşch can be used in visual, auditory and motor skills are recommended as a part of education methods regarding stoma care.
The aim of this study is to evaluate the effects of two different methods in teaching stoma care skills considering patients with colostomy/ileostomy on stoma compliance and self-efficacy levels. This research is the thesis study designed within the scope of the Surgical Diseases Nursing Master's program.
Read the detailed description
Stoma is the opening of the intestine to the abdominal wall. In recent years, the number of individuals with ostomy has been increasing, and it is stated that there are 800,000 individuals in North America alone and approximately 15,000 in Hong Kong.. As a result of this surgical procedure, regardless of ileostomy or colostomy, the daily life of individuals who went through this procedure has been affected in terms of not only the way their bodies excretes but also way of their eating habits, sexual life, self-esteem, religious/cultural needs, social life, sense of independence, self-care and the rest of their daily life.. Gaining patients' self-care activities related to stoma care begins in the preoperative period.
The self-care and development of activities in patients with stoma consists of cognitive, emotional, and psychomotor learning processes.
Patients need to acquire the necessary knowledge and skills to meet their new care needs. This learning process is based on the nurse's practical experience and teaching methods.. After the surgery of individuals with stoma; these individuals need training and counseling in order to manage the stoma functionally and to adapt a life with a stoma in psychological terms. Wound ostomy incontinence nurses; are an unique source of information when it comes to educating the individuals who have stoma.. The American Society of Colon and Rectal Surgeons recommends preoperative stoma training. In the post-operative period after a proper training given to individuals with stoma; It is stated that reduces stoma-related complications, shortens hospital stay, and reduces the cost of stoma care. In the literature, it is stated that the stoma training performed before the surgery shortens the discharge time, reduces the cost and improves the adequacy of the individuals.. The environment, duration, patient's readiness level, past knowledge and experience of patient, education method to be used, education content and material have an important place in patient training. The language of instruction should be plain and simple.. Today, in patient training, verbal information is provided by giving written materials or showing the care practices on the patient after the surgery. While increasing the permanence and effectiveness of the materials used with the developing technology, educational content such as brochures, models, booklets, question-answers, videos and slides also provide good results. However, since the socio demographic characteristics and learning styles of the patients are different from each other, the desired permanence may not be fully achieved. Since stoma care is frequently encountered in nursing practices, is of vital importance, and affects the quality of health care of the individual, family and society, overall it is expected that the permanence of education in this practice will be increased using audio-visual and motor skills, behavior change and self-efficacy will be improved considering the increasing compliance situation in patients with stoma.. Pouresmail et al. (2019) shows that the use of simulation to learn ostomy self-care improves self-efficacy in patients.. In the literature, studies on the subject are limited, and the aim of this study is to determine the effects of two different methods in stoma care education on stoma compliance and self-efficacy levels of patient
- Conditions
- Patient Relations, Nurse, Patient Satisfaction
- Being tested
- Education material - Patient Compatible Stoma Educational Material
- Keywords
- Stoma Adaptation, Self efficacy, Stoma Care education
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education material - Patient Compatible Stoma Educational MaterialOther
It is an educational material made of rubber, similar to a stoma, that can be placed on the patient.
| Study group | Role | What they receive |
|---|---|---|
| Control-Classical patient education | No intervention | Before the operation, the stoma area is marked, the patient is educated with the classical method brochure |
| Experimental-Patient Compatible Stoma Educational Material | Experimental | The stoma area is marked before the operation; A brochure is given to the patient. Practical training is given on the patient's own body with patient-compatible stoma training material. Receives: Other: Education material - Patient Compatible Stoma Educational Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Level
State Anxiety Level is evaluated by Spielberger State-Trait Anxiety Inventory - This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/ she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level
Measured: after surgery, post-operative 1. day (first stoma care)
Secondary outcomes (1)
Stoma Self-Efficacy Scale
In order to determine the self-efficacy levels of individuals with stoma, the psychometric properties of the scale were examined in English, Knippenberg, Van Berge-Henegouwen in 1996. Turkish validity and reliability of the scale Karaçay et al. Adapted by (2020). 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
Measured: The scale is filled in 3 times; 3 days after the surgery (post-operative 3. day) in hospital (1), and at the 3rd week after surgery (post-operative 21. day) at home by telephone (2) and 9th week after surgery (post-operative 63. day) (3) at home by phone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Aug 2021
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Patient Relations, NurseStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Acibadem University, Acibadem University
- Investigators
- Yasemin Uslu, Asisst.Prof, Study director, Acıbadem Mehmet Ali Aydınlar Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308693
- Sponsor's protocol ID
- ATADEK 2021-13/04
- Status last verified
- Jul 2023
- First submitted
- 3 Mar 2022
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karacay P, Togluk Yigitoglu E, Karadag A. The validity and reliability of the Stoma Self-Efficacy Scale: A methodological study. Int J Nurs Pract. 2020 Dec;26(6):e12840. doi: 10.1111/ijn.12840. Epub 2020 Apr 17.
PubMed 32301580Stelton S. CE: Stoma and Peristomal Skin Care: A Clinical Review. Am J Nurs. 2019 Jun;119(6):38-45. doi: 10.1097/01.NAJ.0000559781.86311.64.
PubMed 31135430Giordano V, Nicolotti M, Corvese F, Vellone E, Alvaro R, Villa G. Describing self-care and its associated variables in ostomy patients. J Adv Nurs. 2020 Nov;76(11):2982-2992. doi: 10.1111/jan.14499. Epub 2020 Aug 26.
PubMed 32844474Seo HW. Effects of the frequency of ostomy management reinforcement education on self-care knowledge, self-efficacy, and ability of stoma appliance change among Korean hospitalised ostomates. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):21-28. doi: 10.1111/iwj.13047.
PubMed 30793857Zhang Y, Xian H, Yang Y, Zhang X, Wang X. Relationship between psychosocial adaptation and health-related quality of life of patients with stoma: A descriptive, cross-sectional study. J Clin Nurs. 2019 Aug;28(15-16):2880-2888. doi: 10.1111/jocn.14876. Epub 2019 May 5.
PubMed 30939212Cheng F, Meng AF, Yang LF, Zhang YN. The correlation between ostomy knowledge and self-care ability with psychosocial adjustment in Chinese patients with a permanent colostomy: a descriptive study . Ostomy Wound Manage. 2013 Jul;59(7):35-8.
PubMed 23846005Akbayrak H, Uslu Y. The Effect of Preoperative Stoma Education Including a Wearable Dummy Stoma on Postoperative Stoma-Related Anxiety, Adjustment and Self-Efficacy: a Randomised Controlled Trial. Int J Nurs Pract. 2026 Apr;32(2):e70121. doi: 10.1111/ijn.70121.
PubMed 41806129
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Two Different Methods in Teaching Stoma Care Skills in Patients With Stoma on Stoma Compliance and Self-efficacy Level of Patients
- ClinicalTrials.gov ID
- NCT05308693
- Acronym / sponsor ID
- ATADEK 2021-13/04
- Conditions
- Patient Relations, Nurse, Patient Satisfaction
- Keywords
- Stoma Adaptation, Self efficacy, Stoma Care education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 4 Apr 2022 (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.
In patients with stoma, apart from traditional methods, different methods whşch can be used in visual, auditory and motor skills are recommended as a part of education methods regarding stoma care.
The aim of this study is to evaluate the effects of two different methods in teaching stoma care skills considering patients with colostomy/ileostomy on stoma compliance and self-efficacy levels. This research is the thesis study designed within the scope of the Surgical Diseases Nursing Master's program.
Detailed description
Stoma is the opening of the intestine to the abdominal wall. In recent years, the number of individuals with ostomy has been increasing, and it is stated that there are 800,000 individuals in North America alone and approximately 15,000 in Hong Kong.. As a result of this surgical procedure, regardless of ileostomy or colostomy, the daily life of individuals who went through this procedure has been affected in terms of not only the way their bodies excretes but also way of their eating habits, sexual life, self-esteem, religious/cultural needs, social life, sense of independence, self-care and the rest of their daily life.. Gaining patients' self-care activities related to stoma care begins in the preoperative period.
The self-care and development of activities in patients with stoma consists of cognitive, emotional, and psychomotor learning processes.
Patients need to acquire the necessary knowledge and skills to meet their new care needs. This learning process is based on the nurse's practical experience and teaching methods.. After the surgery of individuals with stoma; these individuals need training and counseling in order to manage the stoma functionally and to adapt a life with a stoma in psychological terms. Wound ostomy incontinence nurses; are an unique source of information when it comes to educating the individuals who have stoma.. The American Society of Colon and Rectal Surgeons recommends preoperative stoma training. In the post-operative period after a proper training given to individuals with stoma; It is stated that reduces stoma-related complications, shortens hospital stay, and reduces the cost of stoma care. In the literature, it is stated that the stoma training performed before the surgery shortens the discharge time, reduces the cost and improves the adequacy of the individuals.. The environment, duration, patient's readiness level, past knowledge and experience of patient, education method to be used, education content and material have an important place in patient training. The language of instruction should be plain and simple.. Today, in patient training, verbal information is provided by giving written materials or showing the care practices on the patient after the surgery. While increasing the permanence and effectiveness of the materials used with the developing technology, educational content such as brochures, models, booklets, question-answers, videos and slides also provide good results. However, since the socio demographic characteristics and learning styles of the patients are different from each other, the desired permanence may not be fully achieved. Since stoma care is frequently encountered in nursing practices, is of vital importance, and affects the quality of health care of the individual, family and society, overall it is expected that the permanence of education in this practice will be increased using audio-visual and motor skills, behavior change and self-efficacy will be improved considering the increasing compliance situation in patients with stoma.. Pouresmail et al. (2019) shows that the use of simulation to learn ostomy self-care improves self-efficacy in patients.. In the literature, studies on the subject are limited, and the aim of this study is to determine the effects of two different methods in stoma care education on stoma compliance and self-efficacy levels of patient
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Control-Classical patient education | No intervention | –Before the operation, the stoma area is marked, the patient is educated with the classical method brochure |
| Experimental-Patient Compatible Stoma Educational Material | Experimental | Other: Education material - Patient Compatible Stoma Educational MaterialThe stoma area is marked before the operation; A brochure is given to the patient. Practical training is given on the patient's own body with patient-compatible stoma training material. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 18-85 years
- Patients who have a colostomy or ileostomy for any reason (cancer, ulcerative colitis, chron, hernia, etc.)
- Patients who can speak and understand Turkish and do not have a psychological or neurological disease (Advanced Parkinson's, Alzheimer's, Depression, etc.)
Key exclusion criteria (5 listed)
- Patients with visual and hearing impairment
- Patients that are unable to use their hands and upper extremities (hemiplegic, paraplegic, etc.)
- Patients who requires a revision surgery after surgery
- Patients whose temporary stoma was closed while in the data collection process
- Patients with postoperative complications and prolonged discharge period (evisceration, bleeding, perforation, etc.) will be excluded from the sample.
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 |
|---|---|---|
| Education material - Patient Compatible Stoma Educational MaterialIt is an educational material made of rubber, similar to a stoma, that can be placed on the patient. | Other | Experimental-Patient Compatible Stoma Educational Material |
Primary outcome
State Anxiety Level
Time frame: after surgery, post-operative 1. day (first stoma care)
State Anxiety Level is evaluated by Spielberger State-Trait Anxiety Inventory - This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/ she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level
1 secondary outcome
Stoma Self-Efficacy Scale
Time frame: The scale is filled in 3 times; 3 days after the surgery (post-operative 3. day) in hospital (1), and at the 3rd week after surgery (post-operative 21. day) at home by telephone (2) and 9th week after surgery (post-operative 63. day) (3) at home by phone
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 24 Jul 2023.
- Background: PubMed 32301580Karacay P, Togluk Yigitoglu E, Karadag A. The validity and reliability of the Stoma Self-Efficacy Scale: A methodological study. Int J Nurs Pract. 2020 Dec;26(6):e12840. doi: 10.1111/ijn.12840. Epub 2020 Apr 17.
- Results publication: PubMed 31135430Stelton S. CE: Stoma and Peristomal Skin Care: A Clinical Review. Am J Nurs. 2019 Jun;119(6):38-45. doi: 10.1097/01.NAJ.0000559781.86311.64.
- Results publication: PubMed 32844474Giordano V, Nicolotti M, Corvese F, Vellone E, Alvaro R, Villa G. Describing self-care and its associated variables in ostomy patients. J Adv Nurs. 2020 Nov;76(11):2982-2992. doi: 10.1111/jan.14499. Epub 2020 Aug 26.
- Results publication: PubMed 30793857Seo HW. Effects of the frequency of ostomy management reinforcement education on self-care knowledge, self-efficacy, and ability of stoma appliance change among Korean hospitalised ostomates. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):21-28. doi: 10.1111/iwj.13047.
- Results publication: PubMed 30939212Zhang Y, Xian H, Yang Y, Zhang X, Wang X. Relationship between psychosocial adaptation and health-related quality of life of patients with stoma: A descriptive, cross-sectional study. J Clin Nurs. 2019 Aug;28(15-16):2880-2888. doi: 10.1111/jocn.14876. Epub 2019 May 5.
- Results publication: PubMed 23846005Cheng F, Meng AF, Yang LF, Zhang YN. The correlation between ostomy knowledge and self-care ability with psychosocial adjustment in Chinese patients with a permanent colostomy: a descriptive study . Ostomy Wound Manage. 2013 Jul;59(7):35-8.
- Derived from this study: PubMed 41806129Akbayrak H, Uslu Y. The Effect of Preoperative Stoma Education Including a Wearable Dummy Stoma on Postoperative Stoma-Related Anxiety, Adjustment and Self-Efficacy: a Randomised Controlled Trial. Int J Nurs Pract. 2026 Apr;32(2):e70121. doi: 10.1111/ijn.70121.
- Individual participant dataSharing planned: No
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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.
Yasemin Uslu, Asisst.Prof study director
Acıbadem Mehmet Ali Aydınlar Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education material - Patient Compatible Stoma Educational Material in people with Patient Relations, Nurse and Patient Satisfaction, run by Acibadem 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 3 inclusion and 5 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 24 Jul 2023. 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?
State Anxiety Level (time frame: after surgery, post-operative 1. day (first stoma care)). 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 NCT05308693, which also lists 7 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 24 Jul 2023.