Virtual Reality Distraction for Pain and Anxiety in Hemodialysis Patients

Effect of Distraction Technique Using Virtual Reality on Pain and Anxiety Level During Needle Insertion in Arteriovenous Fistula Among Hemodialysis Patients: A Randomized Controlled Trial

1. Assess pain and anxiety levels in hemodialysis patients during arteriovenous fistula needle insertion.
2. Determine the effect of the distraction technique using virtual reality on pain and anxiety levels during arteriovenous fistula needle insertion in hemodialysis patients.
3. Find out the differences in the level of pain and anxiety after using virtual reality with regard to the demographic and clinical data of the sample.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Management
• Intervention / Treatment: Device: Virtual Reality; Other: standard of care

Detailed Description

Kidney Failure Requiring Replacement Therapy (KFRT) is a growing global health challenge. In 2023, the number of global cases of KFRT reached 4.59 million, affecting approximately 5 million people worldwide. Regionally, the burden is significant, with 230,000 cases reported in North Africa and the Middle East, and specifically 8,800 cases in Iraq.

Hemodialysis remains the primary life-sustaining treatment for these patients. To perform hemodialysis efficiently, a reliable vascular access is required, with the arteriovenous fistula (AVF) being the gold standard. However, the procedure requires the insertion of large-gauge needles into the fistula repeatedly (usually three times a week), which is often associated with significant pain and distress.

Needle phobia, anticipatory anxiety, and procedure-related pain are common challenges among hemodialysis patients. Unmanaged pain and anxiety can lead to poor adherence to treatment, adverse physiological responses (such as hypertension and tachycardia), and a reduced quality of life.

Virtual Reality (VR) is an immersive technology that draws the patient's attention away from the noxious stimulus by creating a simulated environment. The study aims to evaluate the efficacy of VR as a distraction method to reduce pain and anxiety during AVF cannulation in hemodialysis patients compared to standard care.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hassan A Athbi, Assoc. Prof; Phone Number: +9647721902514; Email: hasan.abdallh@uokerbala.edu.iq
• Study Contact Backup: Name: Astabraq R Hussien, MGS; Phone Number: +9647718107352; Email: astabraq.r@s.uokerbala.edu.iq

Study Locations

• Iraq
  • Karbala, Iraq
    • Imam AL-Hassan AL-Mujtaba Teaching Hospital
  • Karbala, Iraq
    • Imam Al-Hussain Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients with End-Stage Renal Disease (ESRD) on hemodialysis.
• Patients using a functioning arteriovenous fistula (AVF).
• Conscious, oriented, and able to communicate.
• Normal or corrected vision and hearing suitable for VR use.
• Patients capable of giving written informed consent.

Exclusion Criteria:

• History of motion sickness, seizures, or epilepsy.
• Use of Central Venous Catheter (CVC) or Arteriovenous Graft (AVG).
• Use of analgesics or sedatives within 4 hours before the procedure.
• Facial wounds or eye infections preventing VR use.
• Hemodynamic instability or cognitive impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group; Participants in this group will receive distraction therapy using Virtual Reality (VR) glasses during the AVF insertion. The VR session starts 2 minutes before the procedure and continues for 3 minutes during the insertion. Utilizing the Solomon Four-Group Design, this group is randomly subdivided into two subgroups: in Subgroup A, anxiety is assessed before the intervention, while in Subgroup B, no pre-test assessment is performed. Both subgroups undergo post-test measurement for pain and anxiety immediately after the procedure.	Device: Virtual Reality; The intervention involves using VR glasses to provide audiovisual distraction. Participants will watch a 360-degree underwater video with calming music. The VR session starts 2 minutes before the procedure and continues for 3 minutes during the insertion
Active Comparator: Control Group; Participants in this group will receive standard routine nursing care for AVF insertion without any additional distraction techniques. Utilizing the Solomon Four-Group Design, this group is randomly subdivided into two subgroups: in Subgroup C, anxiety is assessed before the procedure, while in Subgroup D, no pre-test assessment is performed. Both subgroups undergo post-test measurement for pain and anxiety immediately after the procedure	Other: standard of care; Routine nursing care for AVF insertion, including skin disinfection and needle insertion according to the hospital's standard protocols, without any additional distraction techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	Pain intensity will be assessed using the Visual Analog Scale (VAS). This scale consists of a 10-cm horizontal line where 0 represents "no pain" and 10 represents "worst possible pain." Participants will mark their perceived pain level on the line immediately after the needle insertion and removal of the VR glasses.	Immediately after the needle insertion procedure
Anxiety Level	The anxiety level will be assessed using the Visual Analog Scale (VAS) for Anxiety. This scale consists of a 10-cm horizontal line, where 0 indicates "no anxiety" and 10 indicates "worst possible anxiety." Participants will be asked to place a mark on the line corresponding to their perceived anxiety level immediately after the needle insertion and removal of the VR glasses.	Immediately after the needle insertion procedure

Collaborators and Investigators

• Sponsor: Karbala University
• Investigators: Principal Investigator: Astabraq R Hussein, MGS, kerbala heath department

Study record dates

Study Major Dates

• Study Start (Estimated): December 25, 2025
• Primary Completion (Estimated): March 25, 2026
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: January 1, 2026
• First Submitted That Met QC Criteria: January 1, 2026
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: UOK.CON.25.0100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No