Virtual Reality Distraction for Pain and Anxiety in Hemodialysis Patients

Karbala University

Status: Not yet enrolling

Conditions: Pain Management

Treatments: Other: standard of care; Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT07334522

UOK.CON.25.0100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Virtual Reality Group

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality

Control Group

Active Comparator group

Description:

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

Treatment:

Other: standard of care