Artificial Intelligence-Supported Nursing Program for Sleep Quality in People With an Ostomy (AI-MNI)

September 3, 2026 updated by: Koç University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Zeytinburnu
      • Istanbul, Zeytinburnu, Turkey (Türkiye), 34010
        • Koc University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-MNI (intervention group)
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
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.
Other Names:
  • Multimodal digital nursing intervention for sleep
  • AI-MNI
No Intervention: Standard stomatherapy care (control group)
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (T0) and 1 month (T1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality at 3 months (Pittsburgh Sleep Quality Index)
Time Frame: Baseline (T0) and 3 months (T2)
PSQI global score, range 0-21; higher scores indicate poorer sleep quality. Change from baseline to the third month, assessing maintenance of the effect.
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)
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.
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 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.
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)
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.
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)
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.
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)
Turkish version of the Stoma Quality of Life Scale; scores converted to a 0-100 range, higher scores indicate better quality of life.
Baseline (T0), 1 month (T1) and 3 months (T2)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the digital intervention and chatbot
Time Frame: 1 month (T1)
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.
1 month (T1)
Module completion rate
Time Frame: Four-week intervention period (baseline to 1 month)
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.
Four-week intervention period (baseline to 1 month)
Total time spent on the digital platform
Time Frame: Four-week intervention period (baseline to 1 month)
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.
Four-week intervention period (baseline to 1 month)
Number of chatbot interactions
Time Frame: Four-week intervention period (baseline to 1 month)
Total number of participant-initiated chatbot interactions recorded automatically by the platform during the four-week intervention period. Assessed in the intervention group only.
Four-week intervention period (baseline to 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

July 15, 2027

Study Registration Dates

First Submitted

August 31, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 4, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025.450.IRB2.204
  • 126S509 (Other Grant/Funding Number: TUBITAK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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