AI-Guided Relaxation for Hemodialysis Anxiety

Official title

Artificial Intelligence-Guided Relaxation Interventions for Reducing Anxiety and Enhancing Coping Strategies in Patients Undergoing Hemodialysis

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.

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.

Interventions

• Device AI-Guided Relaxation Platform
  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.
• Other Standard Hemodialysis Nursing Care
  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

Primary outcome measures

• 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.]]

Secondary outcome measures (4)

• Change in Hospital Anxiety Scale [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 [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 [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 [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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Egypt · 2 centers

• Faculty of Nursing, Alexandria University — Alexandria
• Faculty of Nursing, Alexandria University — Alexandria

Identifiers

NCT: NCT07522944 · AI-IRB00013620HD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗