Double J StentNCT07805018
EFFECT OF VIRTUAL REALITY GLASSES ON ANXIETY AND PAIN DURING DOUBLE J STENT REMOVAL
A study testing Virtual Reality Distraction and Standart of care in people with Double J Stent and Virtual Reality (VR) Technology, run by VOLKAN ENES ÇELİK at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Double J Stent, Virtual Reality (VR) Technology, Anxiety
- What is being tested?
- Virtual Reality Distraction and Standart of care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Trabozn University Faculty of Medicine Kanuni Education and Research Hospital
Trabzon
VOLKAN ENES CELIK, MD, +905358499061, volkanenescelik061@gmail.com
About this study
Official title: EVALUATION OF THE EFFECT OF VIRTUAL REALITY GLASSES ON ANXIETY AND PAIN DURING DOUBLE J STENT REMOVAL USING STAI AND VAS SCORE SCALES
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.
Read the 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:
- 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.
- Conditions
- Double J Stent, Virtual Reality (VR) Technology, Anxiety, Pain
- Being tested
- Virtual Reality Distraction, Standart of care
- Keywords
- VIRTUAL REALITY GLASSES, PAIN, ANXIETY, URETERAL STENT, URETERAL STENT REMOVAL
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DistractionOther
Immersive virtual reality headset used as a non-pharmacological distraction tool during the procedure to reduce pain and anxiety.
Standart of careOther
Standart urological care and routine procedure for double j stent removal without any virtual reality intervention.
| Study group | Role | What they receive |
|---|---|---|
| VIRTUAL REALITY GROUP | Experimental | Patients will undergo double j stent removal while wearing virtual reality glasses for distraction. Receives: Other: Virtual Reality Distraction |
| CONTROL GROUP | Active comparator | Patients will undergo standart double j stent removal without any virtual reality intervention. Receives: Other: Standart of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Ten minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Double J StentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VOLKAN ENES ÇELİK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, VOLKAN ENES ÇELİK, Trabzon Kanuni Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805018
- Sponsor's protocol ID
- 2026/4
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.
PubMed 35397973Toraman RL, Eskici Ilgin V. Effect of Virtual Reality Glasses Application on Pain, Anxiety, and Patient Satisfaction During a Transrectal Prostate Biopsy: A Randomized Controlled Trial. Biol Res Nurs. 2024 Oct;26(4):485-497. doi: 10.1177/10998004241236154. Epub 2024 Feb 28.
PubMed 38418943
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFECT OF VIRTUAL REALITY GLASSES ON ANXIETY AND PAIN DURING DOUBLE J STENT REMOVAL USING STAI AND VAS SCORE SCALES
- ClinicalTrials.gov ID
- NCT07805018
- Acronym / sponsor ID
- 2026/4
- Conditions
- Double J Stent, Virtual Reality (VR) Technology, Anxiety, Pain
- Keywords
- VIRTUAL REALITY GLASSES, PAIN, ANXIETY, URETERAL STENT, URETERAL STENT REMOVAL
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VOLKAN ENES ÇELİKUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIRTUAL REALITY GROUP | Experimental | Other: Virtual Reality DistractionPatients will undergo double j stent removal while wearing virtual reality glasses for distraction. |
| CONTROL GROUP | Active comparator | Other: Standart of carePatients will undergo standart double j stent removal without any virtual reality intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality DistractionImmersive virtual reality headset used as a non-pharmacological distraction tool during the procedure to reduce pain and anxiety. | Other | VIRTUAL REALITY GROUP |
| Standart of careStandart urological care and routine procedure for double j stent removal without any virtual reality intervention. | Other | CONTROL GROUP |
Primary outcome
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.
1 secondary outcome
Visual Analog Scale (VAS) Pain Score
Time frame: Ten minutes after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 35397973Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.
- Background: PubMed 38418943Toraman RL, Eskici Ilgin V. Effect of Virtual Reality Glasses Application on Pain, Anxiety, and Patient Satisfaction During a Transrectal Prostate Biopsy: A Randomized Controlled Trial. Biol Res Nurs. 2024 Oct;26(4):485-497. doi: 10.1177/10998004241236154. Epub 2024 Feb 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Distraction and Standart of care in people with Double J Stent and Virtual Reality (VR) Technology, run by VOLKAN ENES ÇELİK at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VOLKAN ENES CELIK, MD (+905358499061, volkanenescelik061@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (STAI) Score (time frame: Ten minutes before the procedure and ten minutes after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07805018, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.