An interventional study of AI-MNI: Artificial Intelligence-Supported Multimodal Nursing Intervention in Ostomy, Sleep Quality and Quality of Life, sponsored by Koç University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Koç University · Not applicable, Interventional, and Supportive care
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.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 42 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Koç University is the lead sponsor of 109 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: AI-MNI: Artificial Intelligence-Supported Multimodal Nursing 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.
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.
Also known as: Multimodal digital nursing intervention for sleep, AI-MNI
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.
Time frame: Baseline (T0) and 1 month (T1)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T0), 1 month (T1) and 3 months (T2)
Usability of the digital intervention and chatbot
Perceived usability assessed in the intervention group only with the AI-MNI Usability and Functionality Form, a 14-item, 5-point Likert-type instrument adapted from the System Usability Scale and the Chatbot Usability Questionnaire, covering comprehensibility, ease of use, technical performance, supportiveness and overall satisfaction. Total score ranges from 14 to 70; higher scores indicate better perceived usability.
Time frame: 1 month (T1)
Module completion rate
Proportion of the five intervention modules completed by each participant during the four-week intervention period, expressed as a percentage and recorded automatically by the learning management system. Assessed in the intervention group only.
Time frame: Four-week intervention period (baseline to 1 month)
Total time spent on the digital platform
Cumulative session duration in minutes on the learning management system during the four-week intervention period, recorded automatically by the platform. Assessed in the intervention group only.
Time frame: Four-week intervention period (baseline to 1 month)
Number of chatbot interactions
Total number of participant-initiated chatbot interactions recorded automatically by the platform during the four-week intervention period. Assessed in the intervention group only.
Time frame: Four-week intervention period (baseline to 1 month)
Plan to share: 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.
Start is estimated for Oct 2026; primary completion for Mar 2027, 5 months later.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 5 months is below that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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