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AI-Guided Personalized Relaxation for Hemodialysis Patients

20. oktober 2026 oppdatert av: Mohamed Fakhry Ahmed Salem, Alexandria University

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).

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

128

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Alexandria Governorate
      • Alexandria, Alexandria Governorate, Egypt, 2500
        • Faculty of Nursing, Alexandria University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Aktiv komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Health-Related Quality of Life (HRQOL)
Tidsramme: 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.

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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Anxiety Symptoms (GAD-7)
Tidsramme: 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.

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.
Change in Coping Strategies as Measured by the Brief Coping Orientation to Problems Experienced Inventory
Tidsramme: 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.

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.
Technology Acceptance of the AI-Guided Relaxation Program
Tidsramme: post-intervention (T1; 6 weeks).

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).
Qualitative Exploration of Participant Experiences
Tidsramme: post-intervention (T1; 6 weeks).

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).

Samarbeidspartnere og etterforskere

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Studierekorddatoer

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Studer hoveddatoer

Studiestart (Faktiske)

15. april 2026

Primær fullføring (Faktiske)

27. august 2026

Studiet fullført (Faktiske)

30. august 2026

Datoer for studieregistrering

Først innsendt

27. mars 2026

Først innsendt som oppfylte QC-kriteriene

5. april 2026

Først lagt ut (Faktiske)

13. april 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. oktober 2026

Sist bekreftet

1. august 2026

Mer informasjon

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