Artificial Intelligence-Supported Nursing Program for Sleep Quality in People With an Ostomy

NCT07805226 | Not Yet Recruiting

• 2 other identifiers: 2025.450.IRB2.204126S509
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Ostomy; Sleep Quality; Quality of Life

Keywords

Patient Education; Artificial Intelligence; Digital Health; Chatbot; Nursing Intervention; Sleep; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (T0) and 1 month (T1)

Secondary Outcomes (6)

• Sleep quality at 3 months (Pittsburgh Sleep Quality Index)

  Baseline (T0) and 3 months (T2)

• Total sleep time measured with a wrist-worn device

  Baseline (T0), 1 month (T1) and 3 months (T2)

• Sleep efficiency measured with a wrist-worn device

  Baseline (T0), 1 month (T1) and 3 months (T2)

• Sleep onset latency measured with a wrist-worn device

  Baseline (T0), 1 month (T1) and 3 months (T2)

• Proportion of total sleep time spent in deep sleep

  Baseline (T0), 1 month (T1) and 3 months (T2)

Other Outcomes (4)

• Usability of the digital intervention and chatbot

  1 month (T1)

• Module completion rate

  Four-week intervention period (baseline to 1 month)

• Total time spent on the digital platform

  Four-week intervention period (baseline to 1 month)

Study Arms (2)

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.

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.

Interventions

AI-MNI: Artificial Intelligence-Supported Multimodal Nursing Intervention BEHAVIORAL

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

AI-MNI (intervention group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University Hospital

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• Robbins 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.

  PMID: 39460013 BACKGROUND

• Skivington 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.

  PMID: 34593508 BACKGROUND

• Harputlu 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.

  PMID: 37467409 BACKGROUND

• Temiz 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.

  PMID: 35617011 BACKGROUND

• Avci 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.

  PMID: 36640163 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Sleep

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Havanur Kılıç, RN, MSc

CONTACT

+90 850 250 8250; havvanurkilic16@ku.edu.tr

Ayişe Karadağ, Prof

CONTACT

akaradag@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)