Virtual Reality Distraction for Pain and Anxiety in Hemodialysis Patients

ConditionPain Management

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorKarbala University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Virtual Reality GroupExperimental treatment 1 intervention

Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

Immediately after the needle insertion procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karbala University

Lead sponsor

Ministry of Health, Iraq

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: