The AI lives inside the teaching material — a chatbot registered as a behavioural intervention
A randomized controlled trial of a nursing intervention for sleep quality in people with a stoma, built around a four-week programme with a rule-based chatbot embedded in it. The registered intervention is behavioural.
Trial overview (primary data)
- StatusNot yet recruiting
- ConditionsOstomy, Sleep Quality, Quality of Life
- InterventionsBEHAVIORAL: AI-MNI: Artificial Intelligence-Supported Multimodal Nursing Intervention
- SponsorKoç University
- Target enrollment42 participants
- Period2026-10-15 〜 2027-07-15
Key points
- A randomized controlled trial of an artificial intelligence-supported multimodal nursing intervention for sleep quality in adults living with a stoma.
- It is delivered over four weeks through an institutional web-based learning management system in five structured modules.
- Each module combines written material, video, visual guides, checklists and short knowledge checks.
- A rule-based chatbot prioritises content and answers questions, confined to a pre-approved educational content set.
- The chatbot expressly provides no diagnosis, treatment advice or clinical decision support, and target enrolment is 42.
1An AI registered as part of the material
In the three registrations so far the AI analysed, tested or judged. Here it does none of those. It is one part of the machinery supporting a four-week educational programme, and so the intervention field says behavioural.
2What the chatbot is permitted to do
That the exclusions are written into the registration matters. Being rule-based, confining answers to pre-approved content, and staying out of clinical judgment: those three are the conditions on which it fits inside the behavioural box.
3Five modules
- 1Stoma care and night-time comfortAddressing the direct causes: pouch filling, leakage, odour at night
- 2Sleep hygiene and night routineOrdering how the hours before sleep are spent
- 3Psychological wellbeing and relaxationWorking from the side of anxiety and depressive symptoms
- 4Body image, self-esteem and sexual healthAddressing altered body image and social withdrawal
- 5Physical activity and daily energy managementReaching sleep through how the day is spent
That disturbed sleep here has more than one cause is what the five modules express. The registration notes that most existing interventions consist of a single component.
4The behavioural box
The behavioural box holds 116 (14.9%), almost exactly as many as device at 113. AI trials are registered as behavioural interventions as often as they are registered as devices. The next article takes up the largest box of all, other.
Why it matters
Where an AI is embedded as machinery supporting an educational programme, the registered intervention becomes behavioural. Fitting that box turns on being rule-based, confining answers to pre-approved content, and staying clear of clinical judgment, and the registration sets out those exclusions explicitly. Writing down what a system will not do, rather than what it can, is what the classification asks for.
FAQ
What does the chatbot do?
What does it not do?
Why five modules?
Sources (primary)
Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.
- ClinicalTrials.gov (study record, original)
- NCT ID: NCT07805226