- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07522944
AI-Guided Personalized Relaxation for Hemodialysis Patients
Artificial Intelligence-Guided Personalized Relaxation Intervention for Improving Quality of Life, Reducing Anxiety, and Enhancing Coping Strategies in Patients Undergoing Hemodialysis: A Mixed-Methods Randomized Controlled Trial
Patients undergoing maintenance hemodialysis frequently experience impaired health-related quality of life, anxiety, and difficulties in coping with the long-term demands of treatment. Artificial intelligence (AI)-guided interventions may provide personalized psychological support and promote adaptive coping through tailored relaxation strategies.
This randomized controlled mixed-methods trial evaluates the effectiveness of an AI-guided personalized relaxation intervention delivered through a smartphone application among adults receiving maintenance hemodialysis. Participants are randomly assigned to either an intervention group receiving AI-guided personalized relaxation in addition to routine hemodialysis care or a control group receiving routine care alone. The 6-week intervention includes individualized breathing exercises, mindfulness practices, guided imagery, progressive muscle relaxation, and adaptive feedback generated according to participant characteristics, emotional responses, and engagement patterns.
The primary outcome is health-related quality of life measured using the Kidney Disease Quality of Life-36 (KDQOL-36™). Secondary outcomes include anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7), coping strategies measured by the Brief COPE Inventory, and user acceptance of the AI-guided intervention. Qualitative interviews are conducted with intervention participants to explore their experiences, perceived benefits, feasibility, and acceptability of the intervention.
The study aims to determine whether AI-guided personalized relaxation can improve quality of life, reduce anxiety, and enhance coping among patients undergoing maintenance hemodialysis while providing insight into the acceptability and feasibility of integrating AI-supported psychosocial interventions into routine dialysis care.
The personalization system incorporate a pre-trained facial emotion recognition model using the smartphone's front-facing camera. Facial expressions will analyze in real time to classify emotional states (e.g., anxious, neutral, or relaxed) and adapt relaxation recommendations. Facial images will not stored, and the feature will used solely for intervention personalization after informed consent.
Sample size will estimated a priori using GPower (version 3.1) software for a two tailed analysis of difference between two independent means within -t- test family using the following parameters; effect size (Cohen's d = 0.64) which had been reported by Zhang et al. (2025), significance level of 0.05, a statistical power of 90%, and an allocation ratio of 1:1. The minimum sample size will require 106 participants (53 for each group). To compensate for an anticipated attrition rate of 20%, the sample size will increased to 128 participants (64 participants per group).
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Alexandria Governorate
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Alexandria, Alexandria Governorate, Egyiptom, 2500
- Faculty of Nursing, Alexandria University
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria Adults aged 18 years or older. Diagnosed with end-stage renal disease (ESRD). Receiving maintenance hemodialysis for at least 3 months. Able to communicate and complete study questionnaires. Possession of, or access to, a smartphone capable of running the study application.
Willing and able to provide written informed consent. Exclusion Criteria Severe cognitive impairment or inability to complete study assessments. Severe psychiatric illness requiring acute treatment or hospitalization. Significant visual, hearing, or communication impairment preventing participation in the intervention.
Participation in another psychosocial, behavioral, or relaxation intervention study during the study period.
Inability or unwillingness to use the smartphone-based intervention.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: Experimental: AI-Guided Relaxation Group
Description: Participants received a 6-week AI-guided personalized relaxation program delivered through a smartphone application in addition to routine hemodialysis care. The intervention provided individualized relaxation exercises, including guided deep breathing, mindfulness-based relaxation, guided imagery, progressive muscle relaxation, calming audio sessions, and positive coping reinforcement messages. The AI system adapted recommendations based on participant characteristics, emotional responses, engagement patterns, and feedback. Participants completed three 20-30 minute sessions per week during and/or outside hemodialysis sessions. |
Participants received a 6-week AI-guided personalized relaxation program delivered through a smartphone application. The intervention included individualized breathing exercises, mindfulness-based relaxation, guided imagery, progressive muscle relaxation, calming audio sessions, and positive coping reinforcement messages. An AI-based personalization system adapted relaxation recommendations according to participant characteristics, emotional responses, engagement patterns, and user feedback. Participants completed three 20-30 minute sessions per week in addition to routine hemodialysis care. |
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Aktív összehasonlító: Control Group
Participants in this arm will receive only the standard nursing care and routine protocols typically provided during hemodialysis sessions at the study site. No AI-guided relaxation or digital intervention will be administered. Data will be collected at the same time intervals as the intervention group to serve as a baseline for comparison. |
Participants in the control group will receive the routine standard of care provided during maintenance hemodialysis sessions at the study site. This includes standard medical and nursing protocols, monitoring of vital signs, and routine patient education. No AI-guided relaxation interventions will be administered to this group. Data collection (quality of life, anxiety, and coping assessments) was conducted at the same time intervals as the intervention group. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Health-Related Quality of Life (HRQOL)
Időkeret: baseline before the intervention (T0), immediately after completion of the 6-week intervention (T1), and at 1 month (T2) and 3 months (T3) after the end of the intervention.
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Health-related quality of life was assessed using the Kidney Disease Quality of Life-36™ (KDQOL-36™), a validated disease-specific instrument for patients undergoing hemodialysis. The questionnaire generates scores for the Physical Component Summary (PCS), Mental Component Summary (MCS), Burden of Kidney Disease, Symptoms/Problems of Kidney Disease, and Effects of Kidney Disease domains. Scores range from 0 to 100, with higher scores indicating better quality of life. |
baseline before the intervention (T0), immediately after completion of the 6-week intervention (T1), and at 1 month (T2) and 3 months (T3) after the end of the intervention.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Anxiety Symptoms (GAD-7)
Időkeret: baseline before the intervention (T0), immediately after completion of the 6-week intervention (T1), and at 1 month (T2) and 3 months (T3) after the end of the intervention.
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Anxiety symptoms were assessed using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. |
baseline before the intervention (T0), immediately after completion of the 6-week intervention (T1), and at 1 month (T2) and 3 months (T3) after the end of the intervention.
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Change in Coping Strategies as Measured by the Brief Coping Orientation to Problems Experienced Inventory
Időkeret: baseline before the intervention (T0), immediately after completion of the 6-week intervention (T1), and at 1 month (T2) and 3 months (T3) after the end of the intervention.
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Assessed using the Brief Coping Orientation to Problems Experienced (Brief COPE) Inventory (Carver, 1997). The inventory consists of 28 items covering 14 subscales including active coping, planning, positive reframing, acceptance, emotional support, and behavioral disengagement, among others. Each item is scored on a 4-point Likert scale ranging from 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot"). Scores for each subscale range from a minimum of 2 to a maximum of 8. Higher scores on adaptive coping subscales indicate greater reliance on constructive coping strategies. Brief COPE subscale scores were assessed at baseline (T0), post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3), and analyzed longitudinally across all measurement points. |
baseline before the intervention (T0), immediately after completion of the 6-week intervention (T1), and at 1 month (T2) and 3 months (T3) after the end of the intervention.
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Technology Acceptance of the AI-Guided Relaxation Program
Időkeret: post-intervention (T1; 6 weeks).
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Technology acceptance was assessed using an adapted Technology Acceptance Model questionnaire measuring perceived usefulness, perceived ease of use, user satisfaction, and behavioral intention toward continued use of the AI-guided relaxation program. Higher scores indicate greater acceptance. |
post-intervention (T1; 6 weeks).
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Qualitative Exploration of Participant Experiences
Időkeret: post-intervention (T1; 6 weeks).
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Semi-structured interviews will be conducted with participants in the intervention group upon completion of the intervention period to explore their personal experiences, levels of engagement, perceived ease of use of the AI system, and overall satisfaction with the AI-guided relaxation sessions. The interviews will gather detailed insights into how the technology influenced participants' ability to cope with the dialysis procedure and manage treatment-related anxiety. Each interview will last approximately 20-30 minutes and will be audio-recorded with participants' prior informed consent. Data will be analyzed using thematic analysis following the six-phase framework described by Braun and Clarke (2006). |
post-intervention (T1; 6 weeks).
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Urogenitális betegségek
- Mentális zavarok
- Patológiás folyamatok
- Férfi urogenitális betegségek
- Vesebetegségek
- Urológiai betegségek
- Női urogenitális betegségek
- Női urogenitális betegségek és terhességi szövődmények
- Krónikus betegség
- Betegség tulajdonságai
- Viselkedési tünetek
- Veseelégtelenség
- Kóros állapotok, jelek és tünetek
- Viselkedés
- Szorongásos zavarok
- Veseelégtelenség, krónikus
- Veseelégtelenség, krónikus
- Stressz, pszichológiai
Egyéb vizsgálati azonosító számok
- IRB00012098
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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