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NCT Number: NCT07805018

EFFECT OF VIRTUAL REALITY GLASSES ON ANXIETY AND PAIN DURING DOUBLE J STENT REMOVAL

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.

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Key information

Conditions

Double J Stent Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Virtual Reality (VR) Technology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trabozn University Faculty of Medicine Kanuni Education and Research Hospital

Trabzon, Turkey (Türkiye)

Location contact

VOLKAN ENES CELIK, MD

CONTACT

[email protected]

+905358499061

About this study

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:

  • Pre-procedural baseline anxiety will be measured using the State-Trait Anxiety Inventory (STAI).
  • Intra-procedural and immediate post-procedural pain will be assessed using the Visual Analog Scale (VAS).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Distraction

Other

Immersive virtual reality headset used as a non-pharmacological distraction tool during the procedure to reduce pain and anxiety.

Standart of care

Other

Standart urological care and routine procedure for double j stent removal without any virtual reality intervention.

Primary outcomes

  1. State-Trait Anxiety Inventory (STAI) Score

    Time frame: 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 outcomes

  1. Visual Analog Scale (VAS) Pain Score

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

VOLKAN ENES CELIK, MD

CONTACT

[email protected]

+905358499061

Sponsors and collaborators

Lead sponsor

VOLKAN ENES ÇELİK

Other

Registry information

Official study title

EVALUATION OF THE EFFECT OF VIRTUAL REALITY GLASSES ON ANXIETY AND PAIN DURING DOUBLE J STENT REMOVAL USING STAI AND VAS SCORE SCALES

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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