Stoma IleostomyNCT05531331
The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma
A study testing At home education via video conferencing in people with Stoma Ileostomy and Stoma Colostomy, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of stoma care training given at home via videoconferencing after discharge on the self-efficacy and compliance with stoma of individuals with stoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stoma Ileostomy, Stoma Colostomy, Self Efficacy
- What is being tested?
- At home education via video conferencing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 Sep 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Opening stoma for the first time,
- Stoma opening surgery Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, 3rd Floor Surgical Oncology Clinic,
- Whether the opened stoma is a colostomy or an ileostomy,
- Able to speak and understand Turkish,
- be over 18 years old,
- Not having any mental problems that prevent them from being trained and practiced on stoma care,
Show all 9Show fewer
- Not having an obstacle to performing stoma care on their own in terms of vision, hearing and motor skills,
- Possibility of meeting via video conference,
- He voluntarily agrees to participate in the research.
Who cannot join
- Previous stoma opening experience,
- Not being discharged within 10 days after the operation,
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Via Video Conferencing at Home on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma
The aim of this study is to determine the effect of stoma care training given at home via videoconferencing after discharge on the self-efficacy and compliance with stoma of individuals with stoma. In addition to the main purpose, it is aimed to determine whether stoma care education given via video conference at home has an effect on individuals with stoma to perform their own stoma care.
Read the detailed description
After discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the Association of Wound Ostomy Incontinence Nurses and video conference in four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. Individuals with stoma in the control group received the training routinely given in the hospital. Self-efficacy and compliance with stoma were measured at baseline and at 2 months. The ability to care for one's own stoma was evaluated at the end of the study.
- Conditions
- Stoma Ileostomy, Stoma Colostomy, Self Efficacy, Adjustment, Colorectal Cancer, Colorectal Disorders
- Being tested
- At home education via video conferencing
- Keywords
- Adaptation, Colostomy, Education, Ileostomy, Self-Efficacy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At home education via video conferencingBehavioural
Educational booklets are given according to the type of stoma. The individual with the stoma was told that the researcher was always reachable by phone and could communicate if he had any problems. The individuals with stoma in the experimental group received the training of the company representative that sells stoma materials, which is routinely given in the hospital. After discharge, training was given by the researcher via video conference in a total of four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. A post-test was conducted at the end of the 4th training interview, which was administered via video conferencing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | After discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the Association of Wound Ostomy Incontinence Nurses and video conference in four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. Receives: Behavioral: At home education via video conferencing |
| Control Group | No intervention | Individuals with stoma in the control group received the training of the company representative that sells stoma materials routinely in the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the self-efficacy of the experimental group according to the Stoma Self-Efficacy Scale scores at the end of the second month
The Stoma Self-Efficacy Scale was developed to measure self-efficacy in individuals with stoma. The scale was developed by Bekkers et al. (1996). It is a 22-item scale with two sub-dimensions. Items in this scale are in 5-point Likert type. The first sub-dimension is the "Stoma Care Self-Efficacy" sub-dimension, which consists of the first 13 items. The second sub-dimension is the "Social Self-Efficacy" sub-dimension consisting of the remaining nine items. The minimum score that can be taken from the scale is 22, the maximum score is 110, and an increase in the score from the scale indicates high levels of self-efficacy. There is no reverse scored item in the scale.
Measured: Baseline, 2nd month
The change in the adaptation of the experimental group according to the Ostomy Adjustment Inventory-23 scores at the end of the second month
It was created by Maekawa (2000) and later this scale was arranged by Simmons et al. (2009) in the form of Ostomy Adjustment Scale-23, consisting of 23 items and 4 sub-dimensions. OAS-23, a self-assessment scale, is a scale used to evaluate the level of adjustment in individuals with stoma. 4 sub-dimensions in this scale: accepting (includes items 1, 3, 4, 6, 9, 14, 15, 19, 23.), anxiety/worry (12, 13, 17, 20, 21 items) .), social cohesion (includes items 5, 7, 8, 11), and anger (includes items 2 and 10). At the same time, there are 3 items (16, 18 and 22) that are not included in any sub-dimensions. Each item of the scale is evaluated in a 5-point Likert type.
Measured: Baseline, 2nd month
Secondary outcomes (1)
The change in the ability of individuals with stoma to care for their stoma at the end of the 2nd month
After the individuals with stoma in the experimental group were trained by the researcher throughout the study, it was evaluated that they could or could not perform their own stoma care under the supervision of the researcher. However, the status of individuals in the control group for maintaining stoma care is based on their own statements.
Measured: Baseline, 2nd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Nov 2021
- Primary completion1 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Stoma IleostomyStudies of the same condition, open and under way.
- More trials run by Ankara 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
- This study is a parallel group randomized controlled study.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edanur Ozkaya, Ankara University
- Investigators
- Deniz HARPUTLU, PhD, RN, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531331
- Sponsor's protocol ID
- 56786525-050.04.04/236864
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will share.
Publications
Dinuzzi VP, Palomba G, Minischetti M, Amendola A, Aprea P, Luglio G, De Palma GD, Aprea G. Telemedicine in Patients With an Ostomy During the COVID-19 Pandemic: A Retrospective Observational Study. Wound Manag Prev. 2021 Jan;67(1):12-17.
PubMed 33448938Jin Y, Ma H, Jimenez-Herrera M. Self-disgust and stigma both mediate the relationship between stoma acceptance and stoma care self-efficacy. J Adv Nurs. 2020 Oct;76(10):2547-2558. doi: 10.1111/jan.14457. Epub 2020 Jul 23.
PubMed 32700799Krogsgaard M, Kristensen HO, Furnee EJB, Verkuijl SJ, Rama NJ, Domingos H, Maciel J, Solis-Pena A, Espin-Basany E, Hidalgo-Pujol M, Biondo S, Sjovall A, Emmertsen KJ, Thyo A, Christensen P. Life with a stoma across five European countries-a cross-sectional study on long-term rectal cancer survivors. Support Care Cancer. 2022 Nov;30(11):8969-8979. doi: 10.1007/s00520-022-07293-y. Epub 2022 Aug 5.
PubMed 35930059Nam KH, Kim HY, Kim JH, Kang KN, Na SY, Han BH. Effects of social support and self-efficacy on the psychosocial adjustment of Korean ostomy patients. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):13-20. doi: 10.1111/iwj.13038.
PubMed 30793862Seo 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 30793857Wang QQ, Zhao J, Huo XR, Wu L, Yang LF, Li JY, Wang J. Effects of a home care mobile app on the outcomes of discharged patients with a stoma: A randomised controlled trial. J Clin Nurs. 2018 Oct;27(19-20):3592-3602. doi: 10.1111/jocn.14515. Epub 2018 Jul 10.
PubMed 29775491Wen SL, Li J, Wang AN, Lv MM, Li HY, Lu YF, Zhang JP. Effects of transtheoretical model-based intervention on the self-management of patients with an ostomy: A randomised controlled trial. J Clin Nurs. 2019 May;28(9-10):1936-1951. doi: 10.1111/jocn.14731. Epub 2019 Feb 18.
PubMed 30549366White T, Watts P, Morris M, Moss J. Virtual Postoperative Visits for New Ostomates. Comput Inform Nurs. 2019 Feb;37(2):73-79. doi: 10.1097/CIN.0000000000000498.
PubMed 30562169Yan MH, Lv L, Zheng MC, Jin Y, Zhang JE. Quality of Life and Its Influencing Factors Among Chinese Patients With Permanent Colostomy in the Early Postoperative Stage: A Longitudinal Study. Cancer Nurs. 2022 Jan-Feb 01;45(1):E153-E161. doi: 10.1097/NCC.0000000000000893.
PubMed 33003121Zhang JE, Wong FK, You LM, Zheng MC, Li Q, Zhang BY, Huang MR, Ye XM, Liang MJ, Liu JL. Effects of enterostomal nurse telephone follow-up on postoperative adjustment of discharged colostomy patients. Cancer Nurs. 2013 Nov-Dec;36(6):419-28. doi: 10.1097/NCC.0b013e31826fc8eb.
PubMed 23051876Ozkaya E, Harputlu D. The Effect of Education Via Videoconferencing at Home on Individuals' Self-efficacy and Adaptation to Life with a Stoma: A Randomized Controlled Study. Adv Skin Wound Care. 2024 Feb 1;37(2):86-94. doi: 10.1097/ASW.0000000000000098.
PubMed 38241451
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Via Video Conferencing at Home on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma
- ClinicalTrials.gov ID
- NCT05531331
- Acronym / sponsor ID
- 56786525-050.04.04/236864
- Conditions
- Stoma Ileostomy, Stoma Colostomy, Self Efficacy, Adjustment, Colorectal Cancer, Colorectal Disorders
- Keywords
- Adaptation, Colostomy, Education, Ileostomy, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 7 Sep 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.
The aim of this study is to determine the effect of stoma care training given at home via videoconferencing after discharge on the self-efficacy and compliance with stoma of individuals with stoma. In addition to the main purpose, it is aimed to determine whether stoma care education given via video conference at home has an effect on individuals with stoma to perform their own stoma care.
Detailed description
After discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the Association of Wound Ostomy Incontinence Nurses and video conference in four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. Individuals with stoma in the control group received the training routinely given in the hospital. Self-efficacy and compliance with stoma were measured at baseline and at 2 months. The ability to care for one's own stoma was evaluated at the end of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a parallel group randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: At home education via video conferencingAfter discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the Association of Wound Ostomy Incontinence Nurses and video conference in four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. |
| Control Group | No intervention | –Individuals with stoma in the control group received the training of the company representative that sells stoma materials routinely in the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Opening stoma for the first time,
- Stoma opening surgery Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, 3rd Floor Surgical Oncology Clinic,
- Whether the opened stoma is a colostomy or an ileostomy,
- Able to speak and understand Turkish,
- be over 18 years old,
Key exclusion criteria (3 listed)
- Previous stoma opening experience,
- Not being discharged within 10 days after the operation,
- Refusal to participate in the study.
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 |
|---|---|---|
| At home education via video conferencingEducational booklets are given according to the type of stoma. The individual with the stoma was told that the researcher was always reachable by phone and could communicate if he had any problems. The individuals with stoma in the experimental group received the training of the company representative that sells stoma materials, which is routinely given in the hospital. After discharge, training was given by the researcher via video conference in a total of four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. A post-test was conducted at the end of the 4th training interview, which was administered via video conferencing. | Behavioural | Intervention Group |
Primary outcome
The change in the self-efficacy of the experimental group according to the Stoma Self-Efficacy Scale scores at the end of the second month
Time frame: Baseline, 2nd month
The Stoma Self-Efficacy Scale was developed to measure self-efficacy in individuals with stoma. The scale was developed by Bekkers et al. (1996). It is a 22-item scale with two sub-dimensions. Items in this scale are in 5-point Likert type. The first sub-dimension is the "Stoma Care Self-Efficacy" sub-dimension, which consists of the first 13 items. The second sub-dimension is the "Social Self-Efficacy" sub-dimension consisting of the remaining nine items. The minimum score that can be taken from the scale is 22, the maximum score is 110, and an increase in the score from the scale indicates high levels of self-efficacy. There is no reverse scored item in the scale.
The change in the adaptation of the experimental group according to the Ostomy Adjustment Inventory-23 scores at the end of the second month
Time frame: Baseline, 2nd month
It was created by Maekawa (2000) and later this scale was arranged by Simmons et al. (2009) in the form of Ostomy Adjustment Scale-23, consisting of 23 items and 4 sub-dimensions. OAS-23, a self-assessment scale, is a scale used to evaluate the level of adjustment in individuals with stoma. 4 sub-dimensions in this scale: accepting (includes items 1, 3, 4, 6, 9, 14, 15, 19, 23.), anxiety/worry (12, 13, 17, 20, 21 items) .), social cohesion (includes items 5, 7, 8, 11), and anger (includes items 2 and 10). At the same time, there are 3 items (16, 18 and 22) that are not included in any sub-dimensions. Each item of the scale is evaluated in a 5-point Likert type.
1 secondary outcome
The change in the ability of individuals with stoma to care for their stoma at the end of the 2nd month
Time frame: Baseline, 2nd month
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 7 Sep 2022.
- Results publication: PubMed 33448938Dinuzzi VP, Palomba G, Minischetti M, Amendola A, Aprea P, Luglio G, De Palma GD, Aprea G. Telemedicine in Patients With an Ostomy During the COVID-19 Pandemic: A Retrospective Observational Study. Wound Manag Prev. 2021 Jan;67(1):12-17.
- Results publication: PubMed 32700799Jin Y, Ma H, Jimenez-Herrera M. Self-disgust and stigma both mediate the relationship between stoma acceptance and stoma care self-efficacy. J Adv Nurs. 2020 Oct;76(10):2547-2558. doi: 10.1111/jan.14457. Epub 2020 Jul 23.
- Results publication: PubMed 35930059Krogsgaard M, Kristensen HO, Furnee EJB, Verkuijl SJ, Rama NJ, Domingos H, Maciel J, Solis-Pena A, Espin-Basany E, Hidalgo-Pujol M, Biondo S, Sjovall A, Emmertsen KJ, Thyo A, Christensen P. Life with a stoma across five European countries-a cross-sectional study on long-term rectal cancer survivors. Support Care Cancer. 2022 Nov;30(11):8969-8979. doi: 10.1007/s00520-022-07293-y. Epub 2022 Aug 5.
- Results publication: PubMed 30793862Nam KH, Kim HY, Kim JH, Kang KN, Na SY, Han BH. Effects of social support and self-efficacy on the psychosocial adjustment of Korean ostomy patients. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):13-20. doi: 10.1111/iwj.13038.
- 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 29775491Wang QQ, Zhao J, Huo XR, Wu L, Yang LF, Li JY, Wang J. Effects of a home care mobile app on the outcomes of discharged patients with a stoma: A randomised controlled trial. J Clin Nurs. 2018 Oct;27(19-20):3592-3602. doi: 10.1111/jocn.14515. Epub 2018 Jul 10.
- Results publication: PubMed 30549366Wen SL, Li J, Wang AN, Lv MM, Li HY, Lu YF, Zhang JP. Effects of transtheoretical model-based intervention on the self-management of patients with an ostomy: A randomised controlled trial. J Clin Nurs. 2019 May;28(9-10):1936-1951. doi: 10.1111/jocn.14731. Epub 2019 Feb 18.
- Results publication: PubMed 30562169White T, Watts P, Morris M, Moss J. Virtual Postoperative Visits for New Ostomates. Comput Inform Nurs. 2019 Feb;37(2):73-79. doi: 10.1097/CIN.0000000000000498.
- Results publication: PubMed 33003121Yan MH, Lv L, Zheng MC, Jin Y, Zhang JE. Quality of Life and Its Influencing Factors Among Chinese Patients With Permanent Colostomy in the Early Postoperative Stage: A Longitudinal Study. Cancer Nurs. 2022 Jan-Feb 01;45(1):E153-E161. doi: 10.1097/NCC.0000000000000893.
- Results publication: PubMed 23051876Zhang JE, Wong FK, You LM, Zheng MC, Li Q, Zhang BY, Huang MR, Ye XM, Liang MJ, Liu JL. Effects of enterostomal nurse telephone follow-up on postoperative adjustment of discharged colostomy patients. Cancer Nurs. 2013 Nov-Dec;36(6):419-28. doi: 10.1097/NCC.0b013e31826fc8eb.
- Derived from this study: PubMed 38241451Ozkaya E, Harputlu D. The Effect of Education Via Videoconferencing at Home on Individuals' Self-efficacy and Adaptation to Life with a Stoma: A Randomized Controlled Study. Adv Skin Wound Care. 2024 Feb 1;37(2):86-94. doi: 10.1097/ASW.0000000000000098.
- Individual participant dataSharing planned: Yes. All collected IPD will share.
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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.
Deniz HARPUTLU, PhD, RN study director
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing At home education via video conferencing in people with Stoma Ileostomy and Stoma Colostomy, run by Ankara 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 9 inclusion and 3 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 7 Sep 2022. 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?
The change in the self-efficacy of the experimental group according to the Stoma Self-Efficacy Scale scores at the end of the second month (time frame: Baseline, 2nd month). The study lists 2 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 NCT05531331, which also lists 11 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 7 Sep 2022.