Anxiety, Arteriovenous Fistula, Hemodialysis, Needle Insertion and Injection Pain, Pain Management, Virtual Reality
Conditions
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.
Interventions
DEVICEVirtual 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
OTHERstandard 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.
Sponsors
Karbala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain intensity | Immediately after the needle insertion procedure | 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. |
| Anxiety Level | Immediately after the needle insertion procedure | 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. |
Countries
Iraq
Contacts
PRINCIPAL_INVESTIGATORAstabraq R Hussein, MGS
kerbala heath department
Outcome results
None listed