Double J Stent, Virtual Reality (VR) Technology, Anxiety, Pain
Conditions
Keywords
VIRTUAL REALITY GLASSES, PAIN, ANXIETY, URETERAL STENT, URETERAL STENT REMOVAL
Brief summary
This randomized controlled trial aims to investigate the impact of Virtual Reality (VR) as a non-pharmacological distraction method on patient-reported pain and anxiety during the removal of ureteral double-J (DJ) stents. Despite being a standard urological procedure, stent removal is often reported by patients to be a source of significant anxiety and procedure-related pain. By utilizing a standardized distraction environment via VR goggles, this study evaluates whether this intervention can effectively modulate the patient's perception of the procedure. The primary outcomes are measured using the State-Trait Anxiety Inventory (STAI) to assess psychological anxiety and the Visual Analog Scale (VAS) to quantify the intensity of pain experienced throughout the stent removal process.
Detailed description
The removal of ureteral double-J (DJ) stents is an essential procedure in urological practice. However, many patients express concerns regarding the potential for procedural pain, discomfort, and underlying anxiety, which can complicate the clinical experience. While various analgesic and anxiolytic strategies exist, there is a growing clinical imperative to evaluate effective, non-invasive, and non-pharmacological interventions to enhance patient comfort. This prospective, randomized, interventional study will recruit patients scheduled for routine DJ stent removal. The study will allocate participants into an experimental group (receiving VR distraction during the procedure) and a control group (undergoing standard care). The VR intervention consists of immersive visual and auditory stimulation designed to divert the patient's attention from the invasive nature of the procedure. The study will employ a longitudinal assessment approach: 1. Pre-procedural baseline anxiety will be measured using the State-Trait Anxiety Inventory (STAI). 2. Intra-procedural and immediate post-procedural pain will be assessed using the Visual Analog Scale (VAS). 3. Comparative analysis will be performed to determine the statistical significance of VR implementation on these psychometric and pain scales. By integrating virtual reality into the clinical workflow, this research aims to provide evidence-based insights into improving patient experience, potentially reducing the need for pharmaceutical pain management, and standardizing comfort protocols for outpatient urological interventions.
Interventions
OTHERVirtual Reality Distraction
Immersive virtual reality headset used as a non-pharmacological distraction tool during the procedure to reduce pain and anxiety.
OTHERStandart of care
Standart urological care and routine procedure for double j stent removal without any virtual reality intervention.
Sponsors
VOLKAN ENES ÇELİK
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years or older who have undergone ureter or kidney stone surgery and have a double j stent * Willingness and ability to participate voluntarily in the study and provide informed consent
Exclusion criteria
* Patients with double j stents placed forreasons other than ureter or kidney stone surgery * History of motion sickness or vertigo experienced during previous virtual reality use * Visual impairments * History of epilepsy * Cognitive impairment of mental retardation * History of severe psychiatric disorders * Pregnant or breastfeeding women * Patients requesting double j stent removal under sedation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory (STAI) Score | Ten minutes before the procedure and ten minutes after the procedure | Evaluation of patient anxiety levels using the State-Trait Anxiety Inventory (STAI), comprising the State Anxiety (STAI-S) and Trait Anxiety (STAI-T) subscales. Both STAI-S and STAI-T are administered prior to the procedure, whereas only the STAI-S is administered following the procedure. Each subscale yields a score ranging from 20 to 80, where higher scores indicate greater severity of anxiety and lower scores indicate lower levels of anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score | Ten minutes after the procedure | Evaluation of patient pain intensity experienced during the procedure, assessed using the Visual Analog Scale (VAS) administered after the procedure. The scale ranges from 0 to 10, where higher scores indicate greater pain severity (worse outcomes) and lower scores indicate less pain or no pain (better outcomes). |
Countries
Turkey (Türkiye)
Contacts
CONTACTVOLKAN ENES CELIK, MD
Outcome results
None listed