Virtual Reality Distraction for Pain and Anxiety in Hemodialysis Patients

NCT07334522 | Not Yet Recruiting DMC

• 1 other identifier: UOK.CON.25.0100
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

1. 1.Assess pain and anxiety levels in hemodialysis patients during arteriovenous fistula needle insertion.
2. 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. 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.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Virtual Reality 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

Virtual Reality Group

standard of care 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karbala University: lead

Study Sites (2)

Imam Al-Hassan Al-Mujtaba Teaching Hospital

Karbala, Iraq

Location

Imam Al-Hussain Teaching Hospital

Karbala, Iraq

Location

MeSH Terms

Conditions

Agnosia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Astabraq R Hussein, MGS

  kerbala heath department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Astabraq R Hussien, MGS

CONTACT

+9647718107352; astabraq.r@s.uokerbala.edu.iq

Hassan A Athbi, Assoc. Prof

CONTACT

+9647721902514; hasan.abdallh@uokerbala.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Researcher

Model Details: The study will employ a randomized controlled trial using the Solomon four-group design. A total of 150 hemodialysis patients will be recruited and randomly allocated into four groups across two dialysis centers. The design includes two groups with pre-test and post-test measurements and two groups with post-test only, allowing control for pre-test sensitization and strengthening internal validity. The intervention protocol involves the use of virtual reality distraction as follows: * 2 minutes before needle insertion: patients wear the VR headset to establish immersion. * 3 minutes during needle insertion: VR continues throughout the cannulation procedure. * Immediately after completion of needle insertion: the VR headset is removed. Measurement Strategy * Anxiety: assessed using the Visual Analogue Scale for Anxiety (VAS-A), measured before and after the intervention (for pre-test groups). * Pain: assessed using the Visual Analogue Scale (VAS), measured only after the

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 12, 2026
• Study Start: December 25, 2025
• Primary Completion: March 25, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (2)