Renal Insufficiency, ChronicNCT07522944
AI-Guided Personalized Relaxation for Hemodialysis Patients
A study testing AI-Guided Relaxation Platform and Standard Hemodialysis Nursing Care in people with Renal Insufficiency, Chronic and Anxiety, run by Alexandria University at 1 site in Egypt.
Trial summary
Patients undergoing maintenance hemodialysis frequently experience impaired health-related quality of life, anxiety, and difficulties in coping with the long-term demands of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic, Anxiety, Relaxation Therapy
- What is being tested?
- AI-Guided Relaxation Platform and Standard Hemodialysis Nursing Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2026to 13 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Nursing, Alexandria University
Alexandria, Alexandria Governorate, 2500
About this study
Official title: 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.
Read more
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).
- Conditions
- Renal Insufficiency, Chronic, Anxiety, Relaxation Therapy, Maintenance Hemodialysis, Stress, Psychological, Quality of Life
- Being tested
- AI-Guided Relaxation Platform, Standard Hemodialysis Nursing Care
- Keywords
- Hemodialysis, Hospital, Renal Dialysis, End-Stage Renal Disease (ESRD), Psychological Distress, Anxiety, Artificial Intelligence, Digital Health, Relaxation Therapy, Mindfulness-Based Interventions, Coping Skills, AI-Guided Intervention, Quality of Life
- Medical subject headings
- Renal Insufficiency, Chronic, Anxiety Disorders, Stress, Psychological, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Guided Relaxation PlatformDevice
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.
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 (quality of life, anxiety, and coping assessments) was conducted at the same time intervals as the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: AI-Guided Relaxation Group | Experimental | 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. Receives: Device: AI-Guided Relaxation Platform |
| Control Group | Active comparator | 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. Receives: Other: Standard Hemodialysis Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life (HRQOL)
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.
Measured: 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.
Secondary outcomes (4)
Anxiety Symptoms (GAD-7)
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.
Measured: 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
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.
Measured: 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
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.
Measured: post-intervention (T1; 6 weeks).
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).
Measured: post-intervention (T1; 6 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 Apr 2026
- Primary completion10 Sep 2026
- Study completion13 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel-group randomized controlled trial in which eligible participants are randomly assigned to one of two concurrently running arms: an experimental arm receiving the AI-guided relaxation intervention in addition to routine hemodialysis care, and an active comparator arm receiving routine standard hemodialysis care only. Both arms run simultaneously throughout the intervention period of 6 weeks, with outcome assessments conducted at identical time points to enable valid between-group and within-group comparisons.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fakhry Ahmed Salem, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522944
- Sponsor's protocol ID
- IRB00012098
- Status last verified
- Aug 2026
- First submitted
- 27 Mar 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07522944
- Acronym / sponsor ID
- IRB00012098
- Conditions
- Renal Insufficiency, Chronic, Anxiety, Relaxation Therapy, Maintenance Hemodialysis, Stress, Psychological, Quality of Life
- Keywords
- Hemodialysis, Hospital, Renal Dialysis, End-Stage Renal Disease (ESRD), Psychological Distress, Anxiety, Artificial Intelligence, Digital Health, Relaxation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 13 Sep 2026 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A parallel-group randomized controlled trial in which eligible participants are randomly assigned to one of two concurrently running arms: an experimental arm receiving the AI-guided relaxation intervention in addition to routine hemodialysis care, and an active comparator arm receiving routine standard hemodialysis care only. Both arms run simultaneously throughout the intervention period of 6 weeks, with outcome assessments conducted at identical time points to enable valid between-group and within-group comparisons.
| Arm | Type | Receives |
|---|---|---|
| Experimental: AI-Guided Relaxation Group | Experimental | Device: AI-Guided Relaxation PlatformDescription: 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. |
| Control Group | Active comparator | Other: Standard Hemodialysis Nursing CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Guided Relaxation PlatformParticipants 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. | Device | Experimental: AI-Guided Relaxation Group |
| Standard Hemodialysis Nursing CareParticipants 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. | Other | Control Group |
Primary outcome
Health-Related Quality of Life (HRQOL)
Time frame: 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.
4 secondary outcomes
Anxiety Symptoms (GAD-7)
Time frame: 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
Time frame: 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
Time frame: post-intervention (T1; 6 weeks).
Qualitative Exploration of Participant Experiences
Time frame: post-intervention (T1; 6 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Guided Relaxation Platform and Standard Hemodialysis Nursing Care in people with Renal Insufficiency, Chronic and Anxiety, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (HRQOL) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.