NCT07334522

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Karbala University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Pain Management

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2025-12-25
• Primary completion: 2026-03-25
• Completion: 2026-06-20
• First posted: 2026-01-12
• Last updated: 2026-01-13

Locations

2 sites across 1 country: Iraq