Ostomy, Quality of Life, Sleep Quality
Conditions
Keywords
Patient Education, Artificial Intelligence, Digital Health, Chatbot, Nursing Intervention, Sleep, Randomized Controlled Trial
Brief 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 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.
Interventions
BEHAVIORALAI-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.
Sponsors
Koç University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Participants and the researchers delivering the intervention cannot be blinded because of the nature of the intervention; statistical analyses are performed by a statistician blinded to group codes.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep quality (Pittsburgh Sleep Quality Index) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality at 3 months (Pittsburgh Sleep Quality Index) | 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. |
| Total sleep time measured with a wrist-worn device | 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. |
| Sleep efficiency measured with a wrist-worn device | 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. |
| Sleep onset latency measured with a wrist-worn device | 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. |
| Proportion of total sleep time spent in deep sleep | 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. |
| Stoma-specific quality of life (Stoma Quality of Life Scale) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTHavanur Kılıç, RN, MSc
CONTACTAyişe Karadağ, Prof
Outcome results
None listed