Fistulas Arteriovenous, Hemodialysis Patient
Conditions
Keywords
Hemodialysis, Virtual Reality, Pain, State Anxiety
Brief summary
This study aims to determine the effect of virtual reality (VR) goggles used during arteriovenous fistula (AVF) cannulation in hemodialysis patients on pain and anxiety levels. The study is designed as a parallel-group randomized controlled trial and will be conducted with 50 patients receiving treatment at a dialysis center. Participants will be randomly assigned to an experimental group (n=25) and a control group (n=25). Patients in the experimental group will be shown visual-auditory content via VR goggles during AVF needle insertion, while the control group will receive routine care. Data will be collected using the Demographic Information Form, the Visual Analog Scale (VAS), and the State Anxiety Inventory (SAI). Statistical analyses will include appropriate comparative and correlational tests to evaluate differences between groups and relationships between variables.
Detailed description
After generating the randomization list for participant allocation, the study materials will be prepared, including informed consent forms, the Descriptive Characteristics Form, the Visual Analog Scale (VAS), and the State Anxiety Inventory (SAI). Participants will be assigned to experimental and control groups according to the randomization list. In the experimental group, virtual reality intervention will be applied during AVF needle insertion, while the control group will receive standard care procedures. To ensure standardization of the cannulation procedure, all patients in both groups will be cannulated using a 16-gauge arterial and venous needle, inserted at a 30°-45° angle and at least 5 cm from the fistula region, by the same certified hemodialysis nurse. The needle will be secured with hypoallergenic tape. Fifteen minutes after fistula cannulation, outcome measurements will be performed using the Visual Analog Scale (VAS) and the State Anxiety Inventory (SAI).
Interventions
DEVICEVirtual Reality Group
Prior to cannulation, SG goggles were worn, immersive visual/auditory content was shown during the procedure, and the goggles were removed 15 minutes after needle insertion for final measurements. To standardize the procedure, all needle insertions were performed by the same experienced nurse, using a size 16 needle, at least 5 cm away from the fistula site, and at an angle of 30°-45°.
OTHERRoutine Procedure
Only the clinic's routine procedures were followed.
Sponsors
KTO Karatay University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older, * Receiving treatment via AVF, * Having no visual impairment, * Giving voluntary consent.
Exclusion criteria
* Patients with catheter use, * Communication problems, * Antipsychotic medication use, * Analgesic use in the last 12 hours, * Failed (multiple) needle insertion attempts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 15 minutes after AVF cannulation | Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity. |
| Anxiety Level | 15 minutes after AVF cannulation | Anxiety levels will be assessed using the State Anxiety Inventory (SAI). Higher scores indicate higher anxiety levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity from BaselineBaseline Values" | From 15 minutes before cannulation to 15 minutes after cannulation | Change in VAS score from baseline measurement obtained 15 minutes before cannulation to measurement obtained 15 minutes after cannulation. |
| Change in Anxiety Level from Baseline | From 15 minutes before cannulation to 15 minutes after cannulation | Change in SAI score from baseline measurement obtained 15 minutes before cannulation to measurement obtained 15 minutes after cannulation. |
Countries
Turkey (Türkiye)
Outcome results
None listed