End-Stage Kidney Disease (ESKD)NCT07867444
Virtual Reality-Guided Imagery in Hemodialysis Patients ( VRGI-HD )
A study testing virtual reality-guided imagery (VRGI) in people with End-Stage Kidney Disease (ESKD), run by Islamic University of Najaf.
Trial summary
This randomized controlled trial aims to evaluate the effect of virtual reality guided imagery on selected health outcomes among adult patients receiving maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Kidney Disease (ESKD)
- What is being tested?
- virtual reality-guided imagery (VRGI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients aged ≥18 years.
- Diagnosed with end-stage kidney disease (ESKD) and receiving maintenance hemodialysis.
- Undergoing hemodialysis three times per week. Receiving maintenance hemodialysis for at least 3 months before enrollment.
- Able to communicate verbally and understand Arabic.
- Conscious, alert, and able to understand the study procedures and provide written informed consent.
- Able to safely use a VR headset and tolerate the VRGI intervention.
- Agree to participate in the study and comply with the study procedures .
Who cannot join
- Patients with cognitive impairment or altered mental status that may interfere with understanding the intervention or completing the assessment.
- Patients with severe visual or auditory impairment that prevents effective use of the VR intervention.
- Patients with a history of severe motion sickness, vestibular disorders, or significant intolerance to VR.
- Patients who are hemodynamically unstable during the dialysis session.
- Patients experiencing an acute medical complication requiring interruption or modification of the dialysis session.
- Patients who have participated in a similar VR intervention recently, if this could influence the study outcomes.
- Patients who are unable to complete the intervention or outcome assessments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Thulfiqar Mohammed Abdalhussien, PhD candidate contact
Ameer Wahhed Mohammed, PhD candidate contact
About this study
Official title: Effect of Virtual Reality-Guided Imagery on Pain, Anxiety, and Fatigue in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of virtual reality guided imagery on selected health outcomes among adult patients receiving maintenance hemodialysis. Eligible participants will be randomly assigned to either a virtual reality-guided imagery intervention group or a routine-care control group. Participants in the intervention group will receive virtual reality guided imagery during hemodialysis sessions using a virtual reality headset and standardized guided imagery content, while the control group will receive routine care. The study will assess whether virtual reality-guided imagery can improve the selected outcomes among patients undergoing hemodialysis.
Read the detailed description
Hemodialysis is an essential treatment for patients with end-stage kidney disease; however, patients undergoing maintenance hemodialysis may experience various physical and psychological symptoms during treatment. These symptoms may negatively affect patients' comfort and overall treatment experience. Virtual reality-guided imagery (VRGI) is a non-pharmacological nursing intervention that combines immersive virtual reality environments with guided imagery techniques. The intervention is designed to provide a relaxing and engaging experience that may help patients shift their attention away from the hemodialysis environment and treatment-related discomfort. In this randomized controlled trial, VRGI will be provided to eligible adult patients receiving maintenance hemodialysis. Participants allocated to the intervention group will receive standardized VR-guided imagery using a virtual reality headset during a hemodialysis session, while participants in the control group will receive routine care. The intervention will be delivered in a standardized manner to ensure consistency across participants. The study will evaluate the effect of VRGI on the prespecified study outcomes and compare changes between the intervention and routine-care groups. The study is based on the use of a non-pharmacological, patient-centered nursing intervention intended to promote comfort during hemodialysis. The findings may provide evidence regarding the feasibility and potential benefits of incorporating virtual reality-guided imagery into nursing care for patients receiving maintenance hemodialysis.
- Conditions
- End-Stage Kidney Disease (ESKD)
- Being tested
- virtual reality-guided imagery (VRGI)
- Keywords
- Pain, Anxaiety, VRGI, Fatigue
- Medical subject headings
- Kidney Failure, Chronic, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality-guided imagery (VRGI)Behavioural
Also called VRGI
Virtual reality-guided imagery (VRGI) is a non pharmacological behavioral intervention delivered during a hemodialysis session using a virtual reality headset. Participants will experience standardized immersive visual content accompanied by guided imagery audio designed to promote relaxation and provide distraction from the hemodialysis environment. The intervention will be delivered in a standardized manner in addition to routine hemodialysis care.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 VRGI | Experimental | Participants assigned to this group will receive standardized virtual reality-guided imagery (VRGI) during a hemodialysis session in addition to routine care. The intervention will be delivered using a virtual reality headset and standardized guided imagery content designed to provide a relaxing and immersive experience during hemodialysis. Receives: Behavioral: virtual reality-guided imagery (VRGI) |
| Arm 2 Routine care | No intervention | Participants assigned to this group will receive routine hemodialysis care according to the usual clinical practice of the dialysis unit without the virtual reality guided imagery intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.
Measured: Immediately before and immediately after the hemodialysis session/intervention
Secondary outcomes (2)
Anxiety
Anxiety measured using the 6-item State-Trait Anxiety Inventory (STAI-6), with higher scores indicating greater state anxiety.
Measured: Immediately before and immediately after the hemodialysis session/intervention
Fatigue
Fatigue severity will be assessed using a Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no fatigue and 10 indicates the worst possible fatigue. Higher scores indicate greater fatigue severity.
Measured: Immediately before and immediately after the hemodialysis session/intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Kidney Disease (ESKD)Studies of the same condition, open and under way.
- 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
- Parallel Assignment Participants will be randomly assigned to either the virtual reality-guided imagery intervention group or the routine-care control group. Each participant will remain in the assigned group throughout the study.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Islamic University of Najaf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thoalfokar Mohammed, Islamic University of Najaf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867444
- Sponsor's protocol ID
- IUN-CMT-DHD-VRGI-2026
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality-Guided Imagery on Pain, Anxiety, and Fatigue in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07867444
- Acronym / sponsor ID
- IUN-CMT-DHD-VRGI-2026
- Conditions
- End-Stage Kidney Disease (ESKD)
- Keywords
- Pain, Anxaiety, VRGI, Fatigue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Islamic University of NajafUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 9 Oct 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.
This randomized controlled trial aims to evaluate the effect of virtual reality guided imagery on selected health outcomes among adult patients receiving maintenance hemodialysis. Eligible participants will be randomly assigned to either a virtual reality-guided imagery intervention group or a routine-care control group. Participants in the intervention group will receive virtual reality guided imagery during hemodialysis sessions using a virtual reality headset and standardized guided imagery content, while the control group will receive routine care. The study will assess whether virtual reality-guided imagery can improve the selected outcomes among patients undergoing hemodialysis.
Detailed description
Hemodialysis is an essential treatment for patients with end-stage kidney disease; however, patients undergoing maintenance hemodialysis may experience various physical and psychological symptoms during treatment. These symptoms may negatively affect patients' comfort and overall treatment experience. Virtual reality-guided imagery (VRGI) is a non-pharmacological nursing intervention that combines immersive virtual reality environments with guided imagery techniques. The intervention is designed to provide a relaxing and engaging experience that may help patients shift their attention away from the hemodialysis environment and treatment-related discomfort. In this randomized controlled trial, VRGI will be provided to eligible adult patients receiving maintenance hemodialysis. Participants allocated to the intervention group will receive standardized VR-guided imagery using a virtual reality headset during a hemodialysis session, while participants in the control group will receive routine care. The intervention will be delivered in a standardized manner to ensure consistency across participants. The study will evaluate the effect of VRGI on the prespecified study outcomes and compare changes between the intervention and routine-care groups. The study is based on the use of a non-pharmacological, patient-centered nursing intervention intended to promote comfort during hemodialysis. The findings may provide evidence regarding the feasibility and potential benefits of incorporating virtual reality-guided imagery into nursing care for patients receiving maintenance hemodialysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment Participants will be randomly assigned to either the virtual reality-guided imagery intervention group or the routine-care control group. Each participant will remain in the assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 VRGI | Experimental | Behavioral: virtual reality-guided imagery (VRGI)Participants assigned to this group will receive standardized virtual reality-guided imagery (VRGI) during a hemodialysis session in addition to routine care. The intervention will be delivered using a virtual reality headset and standardized guided imagery content designed to provide a relaxing and immersive experience during hemodialysis. |
| Arm 2 Routine care | No intervention | –Participants assigned to this group will receive routine hemodialysis care according to the usual clinical practice of the dialysis unit without the virtual reality guided imagery intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged ≥18 years.
- Diagnosed with end-stage kidney disease (ESKD) and receiving maintenance hemodialysis.
- Undergoing hemodialysis three times per week. Receiving maintenance hemodialysis for at least 3 months before enrollment.
- Able to communicate verbally and understand Arabic.
- Conscious, alert, and able to understand the study procedures and provide written informed consent.
Key exclusion criteria (7 listed)
- Patients with cognitive impairment or altered mental status that may interfere with understanding the intervention or completing the assessment.
- Patients with severe visual or auditory impairment that prevents effective use of the VR intervention.
- Patients with a history of severe motion sickness, vestibular disorders, or significant intolerance to VR.
- Patients who are hemodynamically unstable during the dialysis session.
- Patients experiencing an acute medical complication requiring interruption or modification of the dialysis session.
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 |
|---|---|---|
| virtual reality-guided imagery (VRGI)Also: VRGIVirtual reality-guided imagery (VRGI) is a non pharmacological behavioral intervention delivered during a hemodialysis session using a virtual reality headset. Participants will experience standardized immersive visual content accompanied by guided imagery audio designed to promote relaxation and provide distraction from the hemodialysis environment. The intervention will be delivered in a standardized manner in addition to routine hemodialysis care. | Behavioural | Arm 1 VRGI |
Primary outcome
Pain intensity
Time frame: Immediately before and immediately after the hemodialysis session/intervention
Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.
2 secondary outcomes
Anxiety
Time frame: Immediately before and immediately after the hemodialysis session/intervention
Fatigue
Time frame: Immediately before and immediately after the hemodialysis session/intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 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.
Thulfiqar Mohammed Abdalhussien, PhD candidate contact
Ameer Wahhed Mohammed, PhD candidate contact
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality-guided imagery (VRGI) in people with End-Stage Kidney Disease (ESKD), run by Islamic University of Najaf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thulfiqar Mohammed Abdalhussien, PhD candidate (07831476489, thulfiqar.abd2402p@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Immediately before and immediately after the hemodialysis session/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 9 Oct 2026.