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AI-Guided Personalized Relaxation for Hemodialysis Patients

2026年10月20日 更新者: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).

調査の概要

研究の種類

介入

入学 (実際)

128

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Alexandria Governorate
      • Alexandria、Alexandria Governorate、エジプト、2500
        • Faculty of Nursing, Alexandria University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Health-Related Quality of Life (HRQOL)
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Anxiety Symptoms (GAD-7)
時間枠: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
時間枠: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
時間枠: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
時間枠: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).

協力者と研究者

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月15日

一次修了 (実際)

2026年8月27日

研究の完了 (実際)

2026年8月30日

試験登録日

最初に提出

2026年3月27日

QC基準を満たした最初の提出物

2026年4月5日

最初の投稿 (実際)

2026年4月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月23日

QC基準を満たした最後の更新が送信されました

2026年10月20日

最終確認日

2026年8月1日

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