AI-Guided Relaxation for Hemodialysis Anxiety

Alexandria University60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Interventions

AI-Guided Relaxation PlatformDEVICE

An AI-driven software system designed to provide real-time, adaptive relaxation prompts and personalized relaxation guidance to help hemodialysis patients manage anxiety and improve psychological coping mechanisms. Each session lasts approximately 20-30 minutes and is delivered two to three times per week over four to six weeks using a tablet or mobile device with headphones during routine dialysis sessions.

Standard Hemodialysis Nursing CareOTHER

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 (anxiety, depression, and coping assessments) will be conducted at the same time intervals as the intervention group to provide a baseline for comparison.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Generalized Anxiety Level

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.

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.]

Secondary Outcomes

Change in Hospital Anxiety Scale

Assessed using the full Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983). The HADS comprises 14 items across two subscales: HADS-A (items 1, 3, 5, 7, 9, 11, 13) assessing anxiety symptoms, and HADS-D (items 2, 4, 6, 8, 10, 12, 14) assessing depressive symptoms. Each subscale is scored 0-21, with thresholds of 0-7 (normal), 8-10 (borderline), and 11-21 (clinically significant). This instrument is specifically designed to detect anxiety and depression in patients with physical health conditions such as chronic kidney disease by focusing on psychological rather than somatic symptoms. Change will be calculated as the difference between baseline and post-intervention scores.

Time frame: 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

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. Change will be calculated as the difference between baseline scores and post-intervention scores.

Time frame: 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

Perceived relaxation will be assessed using two complementary instruments administered immediately following each AI-guided relaxation session. First, the Relaxation State Questionnaire (RSQ; Steghaus \& Poth, 2022) is a validated 10-item self-report instrument measuring momentary subjective relaxation states across four subscales: Muscle Scale, Cardiovascular Scale, General Relaxation Scale, and Sleepiness Scale. Each item is rated on a 5-point Likert scale (1 = Not correct at all to 5 = Entirely correct), with reverse-scored items as indicated. Second, a 100mm Visual Analog Scale for Relaxation (VAS-R) will be used, where the left anchor (0) represents "Not relaxed at all" and the right anchor (100) represents "Completely relaxed." Patients mark a point on the line representing their current relaxation state. Higher scores on both instruments indicate a deeper and more effective state of perceived relaxation. Both measures are administered to the intervention group only.

Time frame: 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

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).

Time frame: Time Frame: Conducted with intervention group participants only, immediately following the completion of the full 4-6 week intervention period and post-intervention assessment.