NCT07867444

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jan 2027

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

2 months

First QC Date

October 1, 2026

Last Update Submit

October 6, 2026

Conditions

Keywords

PainAnxaietyVRGIFatigue

Outcome Measures

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.

    Immediately before and immediately after the hemodialysis session/intervention

Secondary Outcomes (2)

  • Anxiety

    Immediately before and immediately after the hemodialysis session/intervention

  • Fatigue

    Immediately before and immediately after the hemodialysis session/intervention.

Study Arms (2)

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.

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

Interventions

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.

Also known as: VRGI
Arm 1 VRGI

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, ChronicPainFatigue

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Thulfiqar Mohammed Abdalhussien, PhD candidate

CONTACT

Ameer Wahhed Mohammed, PhD candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

October 1, 2026

First Posted

October 9, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share