Artificial Intelligence-Guided Relaxation Interventions for Reducing Anxiety and Enhancing Coping Strategies in Patients Undergoing Hemodialysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Alexandria University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in Generalized Anxiety Level
Study Overview
Brief Summary
This study aims to evaluate whether a relaxation program guided by Artificial Intelligence (AI) can help reduce anxiety and improve coping mechanisms for patients receiving maintenance hemodialysis. Patients undergoing dialysis often face significant psychological stress and physical discomfort. This research uses a randomized controlled trial (RCT) with a parallel-group, pretest-posttest controlled design to compare patient well-being before and after using the AI-guided intervention.
Participants will engage with an AI system designed to provide personalized relaxation techniques during their dialysis sessions. The study uses a mixed-methods approach. Quantitative: Researchers will use standardized scales to measure changes in anxiety levels, depression, coping strategies, and perceived relaxation. Qualitative: Researchers will conduct interviews with participants to understand their personal experiences, how they engaged with the AI technology, and how it influenced their ability to manage the stress of their treatment.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients aged 18 years or older Confirmed diagnosis of end-stage renal disease (ESRD) receiving maintenance hemodialysis for at least 3 months to ensure treatment stability Conscious, oriented, and able to communicate effectively Documented baseline anxiety at a mild-to-moderate level confirmed on initial screening using the GAD-7 or HADS prior to enrollment Adequate visual and auditory functions sufficient to interact with the AI-guided relaxation platform Willing to participate and provide written informed consent prior to enrollment
Exclusion Criteria
- •History of epilepsy, chronic vertigo, or seizure disorders, as AI or VR visual stimuli may trigger adverse episodes Severe cognitive impairment or diagnosed psychiatric disorders such as dementia or schizophrenia that prevent comprehension of or adherence to study instructions Acute medical complications or hemodynamic instability occurring during the dialysis session Severe visual impairment or blindness precluding use of the digital relaxation interface Skin infections or injuries on the face or head preventing comfortable use of a headset where applicable Currently enrolled in any other psychological or relaxation intervention study
Arms & Interventions
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.
Intervention: Standard Hemodialysis Nursing Care (Other)
Experimental: AI-Guided Relaxation Group
Participants in this arm will receive an artificial intelligence (AI)-guided relaxation intervention during their regular maintenance hemodialysis sessions. The intervention utilizes AI-driven algorithms to provide personalized relaxation techniques including deep breathing exercises, progressive muscle relaxation (PMR), guided imagery, and mindfulness-based strategies, delivered via a digital platform with headphones. Outcomes include changes in anxiety (GAD-7 and HADS), depression (HADS-D), coping strategies (Brief COPE), and perceived relaxation (RSQ and VAS-R) measured pre- and post-intervention.
Intervention: AI-Guided Relaxation Platform (Device)
Outcomes
Primary Outcomes
Change in Generalized Anxiety Level
Time Frame: Baseline (immediately before the hemodialysis session) and Post-intervention (immediately after the same session).
Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. This tool will evaluate the immediate effect of the AI-guided relaxation on the patient's anxiety level during the hemodialysis session. It is a 7-item self-report tool where scores range from 0 to 21. Higher scores indicate greater anxiety (0-4: Minimal; 5-9: Mild; 10-14: Moderate; 15-21: Severe)
Change in Generalized Anxiety Level
Time Frame: Baseline prior to commencement of the intervention period (Week 0) and post-intervention immediately following completion of the full 4-6 week intervention period.]
Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale (Spitzer et al., 2006). It is a 7-item self-report tool where scores range from 0 to 21. Higher scores indicate greater anxiety (0-4: Minimal; 5-9: Mild; 10-14: Moderate; 15-21: Severe). Change will be calculated as the difference between baseline and post-intervention scores.
Secondary Outcomes
- Change in Hospital Anxiety Scale(Immediately after the completion of the hemodialysis session.)
- Change in Coping Strategies as Measured by the Brief Coping Orientation to Problems Experienced Inventory(Baseline and immediately following the completion of the artificial intelligence-guided relaxation intervention period.)
- Perceived Relaxation Level as Measured by a Visual Analog Scale (VAS)(Immediately following the completion of each artificial intelligence-guided relaxation session during the hemodialysis treatment)
- Qualitative Exploration of Participant Experiences(Immediately after the completion of the hemodialysis session.)
- Change in Hospital Anxiety Scale(Time Frame: Baseline prior to commencement of the intervention period (Week 0) and post-intervention immediately following completion of the full 4-6 week intervention period.)
- Change in Coping Strategies as Measured by the Brief Coping Orientation to Problems Experienced Inventory(Time Frame: Baseline prior to commencement of the intervention period (Week 0) and post-intervention immediately following completion of the full 4-6 week intervention period.)
- Momentary Perceived Relaxation Level as Measured by the RSQ and VAS-R(Time Frame: Administered to the intervention group only, immediately following the completion of each individual AI-guided relaxation session throughout the 4-6 week intervention period (approximately 8-18 sessions per participant)
- Qualitative Exploration of Participant Experiences(Time Frame: Conducted with intervention group participants only, immediately following the completion of the full 4-6 week intervention period and post-intervention assessment.)
Investigators
Mohamed Fakhry Ahmed Salem
Dr
Alexandria University