Virtual Reality Distraction for Pain and Anxiety in Hemodialysis Patients

NCT ID: NCT07334522

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-25
• Study Completion Date: 2026-06-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

standard of care

Intervention Type: OTHER

Routine nursing care for AVF insertion, including skin disinfection and needle insertion according to the hospital's standard protocols, without any additional distraction techniques.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karbala University

OTHER

Sponsor Role: lead

Responsible Party

Astabraq Rassoul Hussein Abass

Graduate Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Astabraq R Hussein, MGS

Role: PRINCIPAL_INVESTIGATOR

kerbala heath department

Locations

Imam Al-Hassan Al-Mujtaba Teaching Hospital

Karbala, , Iraq

Imam Al-Hussain Teaching Hospital

Karbala, , Iraq

Countries

Iraq

Central Contacts

Astabraq R Hussien, MGS

Role: CONTACT

astabraq.r@s.uokerbala.edu.iq

+9647718107352

Hassan A Athbi, Assoc. Prof

Role: CONTACT

hasan.abdallh@uokerbala.edu.iq

+9647721902514

Other Identifiers

UOK.CON.25.0100

Identifier Type: -

Identifier Source: org_study_id