OstomyAI-MNINCT07805226
Artificial Intelligence-Supported Nursing Program for Sleep Quality in People With an Ostomy
A study testing AI-MNI: Artificial Intelligence-Supported Multimodal Nursing Intervention in people with Ostomy and Sleep Quality, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
Individuals living with an intestinal or urinary stoma frequently report disturbed sleep. Night-time pouch filling and leakage, odour and gas concerns, restricted sleeping positions, peristomal skin problems and the need for night-time pouch emptying interrupt sleep, while anxiety, depressive symptoms, altered body… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy, Sleep Quality, Quality of Life
- What is being tested?
- AI-MNI: Artificial Intelligence-Supported Multimodal Nursing Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2026to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Living with a colostomy, ileostomy or urostomy for at least three months
- Pittsburgh Sleep Quality Index global score greater than 5, indicating poor sleep quality
- Owns a smartphone with internet access and is able to use the digital modules and the chatbot
- Cognitively able to complete self-report questionnaires and to participate actively in the intervention
- Literate and able to communicate in Turkish
- Provides written informed consent
Who cannot join
- Clinically diagnosed and/or currently treated primary sleep disorder
- Sensory, cognitive or communication impairment that would prevent compliance with study procedures
- Regular use of hypnotics, sedatives, antidepressants or antipsychotics
- Any clinical or social condition that would prevent regular participation in the intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ayişe Karadağ, Prof contact
Turkey (Türkiye)1 site
Koc University Hospital
Istanbul, Zeytinburnu, 34010
Ayişe Karadağ, Prof, +90 850 250 8250 ext. 29712, akaradag@ku.edu.tr
About this study
Official title: The Effect of an Artificial Intelligence-Supported Multimodal Nursing Intervention on Sleep Quality in Individuals With an Ostomy: A Randomized Controlled Trial
Individuals living with an intestinal or urinary stoma frequently report disturbed sleep. Night-time pouch filling and leakage, odour and gas concerns, restricted sleeping positions, peristomal skin problems and the need for night-time pouch emptying interrupt sleep, while anxiety, depressive symptoms, altered body image and social withdrawal add to this burden. Poor sleep in this population has been associated with reduced quality of life and impaired daytime functioning; however, most of the available evidence is cross-sectional and based exclusively on self-reported measures. Nursing interventions that specifically target sleep in people with a stoma are few, generally consist of a single component, and have rarely been tested in randomised designs or alongside objective sleep measurement.
This trial evaluates an Artificial Intelligence-Supported Multimodal Nursing Intervention (AI-MNI) developed to improve sleep quality in adults living with a stoma. The intervention was designed in line with the Medical Research Council framework for complex interventions and is delivered over four weeks through the institutional web-based learning management system. It comprises five structured modules: stoma care and night-time comfort; sleep hygiene and night routine; psychological wellbeing and relaxation techniques; body image, self-esteem and sexual health; and physical activity and daily energy management. Each module combines written material, video, visual guides, checklists and short knowledge checks. A rule-based chatbot embedded in the platform supports participants by prioritising content, suggesting review of relevant material and responding to questions within a pre-approved educational content set; it does not provide diagnosis, treatment advice or clinical decision support. All content was evaluated for content validity by an expert panel before implementation.
The study is a two-arm, parallel-group randomised controlled trial conducted in the stomatherapy unit of a university hospital. Forty-two adults (21 per group) with a colostomy, ileostomy or urostomy of at least three months' duration and a Pittsburgh Sleep Quality Index (PSQI) global score greater than 5 will be allocated in a 1:1 ratio using permuted block randomisation with variable block sizes, stratified by sex and stoma type. Allocation is concealed through a central, password-protected web-based system, and statistical analyses are performed by a statistician blinded to group codes. The intervention group receives AI-MNI in addition to standard care; the control group receives standard care alone and is offered access to the programme after the final assessment (delayed-access design). Assessments are conducted at baseline (T0), at the first month (T1) and at the third month (T2). The primary outcome is the change in PSQI global score from baseline to the first month, with the third-month assessment used to examine whether any improvement is maintained. Secondary outcomes are objective sleep parameters (total sleep time, sleep efficiency, sleep stage indicators and sleep onset latency) recorded with a consumer wrist-worn device on three consecutive nights at each assessment point, and stoma-specific quality of life. Module completion, session duration and level of interaction are reported as process outcomes. Analyses follow the intention-to-treat principle and are based primarily on linear mixed-effects models.
- Conditions
- Ostomy, Sleep Quality, Quality of Life
- Being tested
- AI-MNI: Artificial Intelligence-Supported Multimodal Nursing Intervention
- Keywords
- Patient Education, Artificial Intelligence, Digital Health, Chatbot, Nursing Intervention, Sleep, Randomized Controlled Trial
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-MNI: Artificial Intelligence-Supported Multimodal Nursing InterventionBehavioural
Also called Multimodal digital nursing intervention for sleep, AI-MNI
Four-week, module-based digital nursing intervention delivered through the institutional web-based learning management system, in addition to standard stomatherapy care. Five modules address stoma care and night-time comfort; sleep hygiene and night routine; psychological wellbeing and relaxation techniques; body image, self-esteem and sexual health; and physical activity and daily energy management. Each module combines written material, video, visual guides, checklists and short knowledge checks, and all modules are available throughout the four-week period. A rule-based chatbot embedded in the platform prioritises content, suggests review of relevant material and answers questions within a pre-approved educational content set; it does not provide diagnosis, treatment advice or clinical decision support. Content validity was established with an expert panel, and platform use (module completion, session duration, interaction) is recorded as a process outcome.
| Study group | Role | What they receive |
|---|---|---|
| AI-MNI (intervention group) | Experimental | Participants receive the Artificial Intelligence-Supported Multimodal Nursing Intervention (AI-MNI) in addition to standard stomatherapy care. The intervention is delivered over four weeks through the institutional web-based learning management system and comprises five modules: stoma care and night-time comfort; sleep hygiene and night routine; psychological wellbeing and relaxation techniques; body image, self-esteem and sexual health; and physical activity and daily energy management. Modules combine written material, video, visual guides, checklists and short knowledge checks. A rule-based chatbot embedded in the platform prioritises content, suggests review of relevant material and answers questions within a pre-approved educational content set; it does not provide diagnosis, treatment advice or clinical decision support. Receives: Behavioral: AI-MNI: Artificial Intelligence-Supported Multimodal Nursing Intervention |
| Standard stomatherapy care (control group) | No intervention | Participants receive standard stomatherapy care delivered by the certified stoma and wound care nurses of the unit, including standard ostomy education, counselling and scheduled follow-up visits. They have no access to the AI-MNI modules or the chatbot during the study period, and are offered access to the programme after the final (third-month) assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep quality (Pittsburgh Sleep Quality Index)
PSQI global score, range 0-21; higher scores indicate poorer sleep quality. Change from baseline to the end of the first month.
Measured: Baseline (T0) and 1 month (T1)
Secondary outcomes (6)
Sleep quality at 3 months (Pittsburgh Sleep Quality Index)
PSQI global score, range 0-21; higher scores indicate poorer sleep quality. Change from baseline to the third month, assessing maintenance of the effect.
Measured: Baseline (T0) and 3 months (T2)
Total sleep time measured with a wrist-worn device
Total sleep time in minutes per night, recorded with a consumer wrist-worn device over three consecutive nights at each assessment point and averaged across the three nights. Higher values indicate longer sleep duration.
Measured: Baseline (T0), 1 month (T1) and 3 months (T2)
Sleep efficiency measured with a wrist-worn device
Sleep efficiency, calculated as total sleep time divided by time in bed and expressed as a percentage, recorded with a consumer wrist-worn device over three consecutive nights at each assessment point and averaged across the three nights. Higher values indicate better sleep continuity.
Measured: Baseline (T0), 1 month (T1) and 3 months (T2)
Sleep onset latency measured with a wrist-worn device
Sleep onset latency in minutes, defined as the interval between bedtime and sleep onset, recorded with a consumer wrist-worn device over three consecutive nights at each assessment point and averaged across the three nights. Lower values indicate faster sleep onset.
Measured: Baseline (T0), 1 month (T1) and 3 months (T2)
Proportion of total sleep time spent in deep sleep
Time spent in device-derived deep sleep, expressed as a percentage of total sleep time, recorded with a consumer wrist-worn device over three consecutive nights at each assessment point and averaged across the three nights. Higher values indicate a greater proportion of deep sleep. Device-derived sleep stage estimates are reported as complementary indicators and not as a substitute for polysomnography.
Measured: Baseline (T0), 1 month (T1) and 3 months (T2)
Stoma-specific quality of life (Stoma Quality of Life Scale)
Turkish version of the Stoma Quality of Life Scale; scores converted to a 0-100 range, higher scores indicate better quality of life.
Measured: Baseline (T0), 1 month (T1) and 3 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
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 OstomyStudies of the same condition, open and under way.
- 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
- Two-arm, parallel-group design. Participants are randomised 1:1 to the intervention group (AI-MNI in addition to standard stomatherapy care) or the control group (standard stomatherapy care alone). Control group participants are offered access to the digital programme after the final assessment (delayed-access design).
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805226
- Sponsor's protocol ID
- 2025.450.IRB2.204
- Other IDs
- 126S509
- Acronym
- AI-MNI
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Participants provided informed consent on the basis that their coded data would be accessed only by the research team, would not be shared with third parties, and would be securely destroyed after the institutionally required retention period. Data are processed in accordance with the Turkish Personal Data Protection Law (No. 6698) and the conditions of the approving ethics committee. Aggregate results will be disseminated through peer-reviewed publication.
Publications
Karadağ A, Öztürk D, Çelik B. Adaptation of Quality of Life Scale for the ostomy patients into Turkish. Turkish Journal of Colorectal Disease. 2011;21(4):173-181.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Robbins R, Weaver MD, Sullivan JP, Quan SF, Gilmore K, Shaw S, Benz A, Qadri S, Barger LK, Czeisler CA, Duffy JF. Accuracy of Three Commercial Wearable Devices for Sleep Tracking in Healthy Adults. Sensors (Basel). 2024 Oct 10;24(20):6532. doi: 10.3390/s24206532.
PubMed 39460013Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
PubMed 34593508Harputlu D, Ozturk FO, Aydin D, Akyol C, Tezel A. Effect of Laughter Yoga on Sleep and Quality of Life in Individuals With Fecal Ostomies: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2023 Jul-Aug 01;50(4):307-312. doi: 10.1097/WON.0000000000000988.
PubMed 37467409Temiz Z, Cavdar I, Ozbas A, Altunsoy M, Akyuz N, Kutlu FY. Sleep Quality and Factors Affecting Sleep in Individuals With an Intestinal Ostomy: A Descriptive Cross-Sectional Study. Wound Manag Prev. 2022 May;68(5):28-36. doi: 10.25270/wmp.2022.5.2836.
PubMed 35617011Avci Isik S, Balanuye B, Budak Erturk E, Karahan A, Ustundag C, Ugurlu Z, Oren Hin A, Aydin D, Gocmen Baykara Z, Acarlar H, Akar E, Kosker Y, Koc MA. Sleep Problems in Individuals With Intestinal Stomas and Determining the Quality of Sleep: A Multicenter Study. J Wound Ostomy Continence Nurs. 2023 Jan-Feb 01;50(1):39-46. doi: 10.1097/WON.0000000000000939.
PubMed 36640163
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Artificial Intelligence-Supported Multimodal Nursing Intervention on Sleep Quality in Individuals With an Ostomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07805226
- Acronym / sponsor ID
- AI-MNI / 2025.450.IRB2.204
- Conditions
- Ostomy, Sleep Quality, Quality of Life
- Keywords
- Patient Education, Artificial Intelligence, Digital Health, Chatbot, Nursing Intervention, Sleep, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 4 Sep 2026 (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.
Individuals living with an intestinal or urinary stoma frequently report disturbed sleep. Night-time pouch filling and leakage, odour and gas concerns, restricted sleeping positions, peristomal skin problems and the need for night-time pouch emptying interrupt sleep, while anxiety, depressive symptoms, altered body image and social withdrawal add to this burden. Poor sleep in this population has been associated with reduced quality of life and impaired daytime functioning; however, most of the available evidence is cross-sectional and based exclusively on self-reported measures. Nursing interventions that specifically target sleep in people with a stoma are few, generally consist of a single component, and have rarely been tested in randomised designs or alongside objective sleep measurement.
This trial evaluates an Artificial Intelligence-Supported Multimodal Nursing Intervention (AI-MNI) developed to improve sleep quality in adults living with a stoma. The intervention was designed in line with the Medical Research Council framework for complex interventions and is delivered over four weeks through the institutional web-based learning management system. It comprises five structured modules: stoma care and night-time comfort; sleep hygiene and night routine; psychological wellbeing and relaxation techniques; body image, self-esteem and sexual health; and physical activity and daily energy management. Each module combines written material, video, visual guides, checklists and short knowledge checks. A rule-based chatbot embedded in the platform supports participants by prioritising content, suggesting review of relevant material and responding to questions within a pre-approved educational content set; it does not provide diagnosis, treatment advice or clinical decision support. All content was evaluated for content validity by an expert panel before implementation.
The study is a two-arm, parallel-group randomised controlled trial conducted in the stomatherapy unit of a university hospital. Forty-two adults (21 per group) with a colostomy, ileostomy or urostomy of at least three months' duration and a Pittsburgh Sleep Quality Index (PSQI) global score greater than 5 will be allocated in a 1:1 ratio using permuted block randomisation with variable block sizes, stratified by sex and stoma type. Allocation is concealed through a central, password-protected web-based system, and statistical analyses are performed by a statistician blinded to group codes. The intervention group receives AI-MNI in addition to standard care; the control group receives standard care alone and is offered access to the programme after the final assessment (delayed-access design). Assessments are conducted at baseline (T0), at the first month (T1) and at the third month (T2). The primary outcome is the change in PSQI global score from baseline to the first month, with the third-month assessment used to examine whether any improvement is maintained. Secondary outcomes are objective sleep parameters (total sleep time, sleep efficiency, sleep stage indicators and sleep onset latency) recorded with a consumer wrist-worn device on three consecutive nights at each assessment point, and stoma-specific quality of life. Module completion, session duration and level of interaction are reported as process outcomes. Analyses follow the intention-to-treat principle and are based primarily on linear mixed-effects models.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group design. Participants are randomised 1:1 to the intervention group (AI-MNI in addition to standard stomatherapy care) or the control group (standard stomatherapy care alone). Control group participants are offered access to the digital programme after the final assessment (delayed-access design).
| Arm | Type | Receives |
|---|---|---|
| AI-MNI (intervention group) | Experimental | Behavioral: AI-MNI: Artificial Intelligence-Supported Multimodal Nursing InterventionParticipants receive the Artificial Intelligence-Supported Multimodal Nursing Intervention (AI-MNI) in addition to standard stomatherapy care. The intervention is delivered over four weeks through the institutional web-based learning management system and comprises five modules: stoma care and night-time comfort; sleep hygiene and night routine; psychological wellbeing and relaxation techniques; body image, self-esteem and sexual health; and physical activity and daily energy management. Modules combine written material, video, visual guides, checklists and short knowledge checks. A rule-based chatbot embedded in the platform prioritises content, suggests review of relevant material and answers questions within a pre-approved educational content set; it does not provide diagnosis, treatment advice or clinical decision support. |
| Standard stomatherapy care (control group) | No intervention | –Participants receive standard stomatherapy care delivered by the certified stoma and wound care nurses of the unit, including standard ostomy education, counselling and scheduled follow-up visits. They have no access to the AI-MNI modules or the chatbot during the study period, and are offered access to the programme after the final (third-month) assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older
- Living with a colostomy, ileostomy or urostomy for at least three months
- Pittsburgh Sleep Quality Index global score greater than 5, indicating poor sleep quality
- Owns a smartphone with internet access and is able to use the digital modules and the chatbot
- Cognitively able to complete self-report questionnaires and to participate actively in the intervention
Key exclusion criteria (4 listed)
- Clinically diagnosed and/or currently treated primary sleep disorder
- Sensory, cognitive or communication impairment that would prevent compliance with study procedures
- Regular use of hypnotics, sedatives, antidepressants or antipsychotics
- Any clinical or social condition that would prevent regular participation in the 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 |
|---|---|---|
| AI-MNI: Artificial Intelligence-Supported Multimodal Nursing InterventionAlso: Multimodal digital nursing intervention for sleep, AI-MNIFour-week, module-based digital nursing intervention delivered through the institutional web-based learning management system, in addition to standard stomatherapy care. Five modules address stoma care and night-time comfort; sleep hygiene and night routine; psychological wellbeing and relaxation techniques; body image, self-esteem and sexual health; and physical activity and daily energy management. Each module combines written material, video, visual guides, checklists and short knowledge checks, and all modules are available throughout the four-week period. A rule-based chatbot embedded in the platform prioritises content, suggests review of relevant material and answers questions within a pre-approved educational content set; it does not provide diagnosis, treatment advice or clinical decision support. Content validity was established with an expert panel, and platform use (module completion, session duration, interaction) is recorded as a process outcome. | Behavioural | AI-MNI (intervention group) |
Primary outcome
Change in sleep quality (Pittsburgh Sleep Quality Index)
Time frame: Baseline (T0) and 1 month (T1)
PSQI global score, range 0-21; higher scores indicate poorer sleep quality. Change from baseline to the end of the first month.
6 secondary outcomes
Sleep quality at 3 months (Pittsburgh Sleep Quality Index)
Time frame: Baseline (T0) and 3 months (T2)
Total sleep time measured with a wrist-worn device
Time frame: Baseline (T0), 1 month (T1) and 3 months (T2)
Sleep efficiency measured with a wrist-worn device
Time frame: Baseline (T0), 1 month (T1) and 3 months (T2)
Sleep onset latency measured with a wrist-worn device
Time frame: Baseline (T0), 1 month (T1) and 3 months (T2)
Proportion of total sleep time spent in deep sleep
Time frame: Baseline (T0), 1 month (T1) and 3 months (T2)
Stoma-specific quality of life (Stoma Quality of Life Scale)
Time frame: Baseline (T0), 1 month (T1) and 3 months (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- BackgroundKaradağ A, Öztürk D, Çelik B. Adaptation of Quality of Life Scale for the ostomy patients into Turkish. Turkish Journal of Colorectal Disease. 2011;21(4):173-181.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 39460013Robbins R, Weaver MD, Sullivan JP, Quan SF, Gilmore K, Shaw S, Benz A, Qadri S, Barger LK, Czeisler CA, Duffy JF. Accuracy of Three Commercial Wearable Devices for Sleep Tracking in Healthy Adults. Sensors (Basel). 2024 Oct 10;24(20):6532. doi: 10.3390/s24206532.
- Background: PubMed 34593508Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
- Background: PubMed 37467409Harputlu D, Ozturk FO, Aydin D, Akyol C, Tezel A. Effect of Laughter Yoga on Sleep and Quality of Life in Individuals With Fecal Ostomies: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2023 Jul-Aug 01;50(4):307-312. doi: 10.1097/WON.0000000000000988.
- Background: PubMed 35617011Temiz Z, Cavdar I, Ozbas A, Altunsoy M, Akyuz N, Kutlu FY. Sleep Quality and Factors Affecting Sleep in Individuals With an Intestinal Ostomy: A Descriptive Cross-Sectional Study. Wound Manag Prev. 2022 May;68(5):28-36. doi: 10.25270/wmp.2022.5.2836.
- Background: PubMed 36640163Avci Isik S, Balanuye B, Budak Erturk E, Karahan A, Ustundag C, Ugurlu Z, Oren Hin A, Aydin D, Gocmen Baykara Z, Acarlar H, Akar E, Kosker Y, Koc MA. Sleep Problems in Individuals With Intestinal Stomas and Determining the Quality of Sleep: A Multicenter Study. J Wound Ostomy Continence Nurs. 2023 Jan-Feb 01;50(1):39-46. doi: 10.1097/WON.0000000000000939.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Participants provided informed consent on the basis that their coded data would be accessed only by the research team, would not be shared with third parties, and would be securely destroyed after the institutionally required retention period. Data are processed in accordance with the Turkish Personal Data Protection Law (No. 6698) and the conditions of the approving ethics committee. Aggregate results will be disseminated through peer-reviewed publication.
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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.
Ayişe Karadağ, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-MNI: Artificial Intelligence-Supported Multimodal Nursing Intervention in people with Ostomy and Sleep Quality, run by Koç 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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Havanur Kılıç, RN, MSc (+90 850 250 8250 ext. 2677, havvanurkilic16@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep quality (Pittsburgh Sleep Quality Index) (time frame: Baseline (T0) and 1 month (T1)). 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 NCT07805226, 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 4 Sep 2026.