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

ConditionsDouble J StentVirtual Reality (VR) TechnologyAnxietyPain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVOLKAN ENES ÇELİK

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality Distraction

    Other intervention

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

  • Standart of care

    Other intervention

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

Treatment groups

100 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

1

State-Trait Anxiety Inventory (STAI) Score

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.

Time frame
Ten minutes before the procedure and ten minutes after the procedure

Secondary outcomes

1

Visual Analog Scale (VAS) Pain Score

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).

Time frame
Ten minutes after the procedure

Other outcomes

Sponsors and contacts

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

VOLKAN ENES ÇELİK

Lead sponsor

Trabzon Kanuni Education and Research Hospital

Sponsor institution

Source ClinicalTrials.gov

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