Virtual Reality-Guided Imagery in Hemodialysis Patients ( VRGI-HD )

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIslamic University of Najaf

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • virtual reality-guided imagery (VRGI)

    Behavioral

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Arm 1 VRGIExperimental treatment 1 intervention
Group B: Arm 2 Routine careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediately before and immediately after the hemodialysis session/intervention

Secondary outcomes

1

Anxiety

Anxiety measured using the 6-item State-Trait Anxiety Inventory (STAI-6), with higher scores indicating greater state anxiety.

Time frame
Immediately before and immediately after the hemodialysis session/intervention
2

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.

Time frame
Immediately before and immediately after the hemodialysis session/intervention.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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