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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Health-Related Quality of Life (HRQOL)
研究概览
简要总结
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 12-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.
详细描述
A total of 60 adult patients undergoing maintenance hemodialysis will be recruited and randomized into two parallel groups: an intervention group (n = 30) and a control group (n = 30). Randomization will be performed using a computer-generated block randomization procedure to ensure balanced allocation. The intervention group will receive AI-guided relaxation sessions during their dialysis treatment, while the control group will receive routine standard care only. A mixed-methods approach is employed to evaluate the effectiveness, where quantitative data (anxiety, depression, coping, and relaxation levels) are collected at baseline and post-intervention, and qualitative data are gathered via semi-structured interviews to explore the intervention group's experiences and engagement with the AI technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study is conducted as a single-blind trial. Due to the nature of the intervention, masking of participants and care providers is not feasible, as participants are necessarily aware of whether they are receiving the AI-guided relaxation program or standard care only. However, the researcher responsible for statistical analysis and outcome assessment is blinded to group allocation throughout the entire data analysis phase. Group allocation codes are concealed from the outcomes assessor until all data collection is complete and the dataset is locked. This approach minimizes detection bias and ensures the integrity of the outcome evaluation process.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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. Withdrawal of consent at any stage of the study.
研究组 & 干预措施
Experimental: AI-Guided Relaxation Group
Description: Participants received a 12-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.
干预措施: AI-Guided Relaxation Platform (Device)
Control Group (No Intervention)
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.
干预措施: Standard Hemodialysis Nursing Care (Other)
结局指标
主要结局
Health-Related Quality of Life (HRQOL)
时间窗: Baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3).
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.
次要结局
- Anxiety Symptoms (GAD-7)(Baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3).)
- Change in Coping Strategies as Measured by the Brief Coping Orientation to Problems Experienced Inventory(Baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3).)
- Technology Acceptance of the AI-Guided Relaxation Program(post-intervention (T1; 12 weeks).)
- Qualitative Exploration of Participant Experiences(Time Frame: post-intervention (T1; 12 weeks).)
研究者
Mohamed Fakhry Ahmed Salem
Dr
Alexandria University