NCT07805018

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Sep 2026Jul 2027

First Submitted

Initial submission to the registry

August 11, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

September 4, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

August 11, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

VIRTUAL REALITY GLASSESPAINANXIETYURETERAL STENTURETERAL STENT REMOVAL

Outcome Measures

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.

    Ten minutes before the procedure and ten minutes after the procedure

Secondary Outcomes (1)

  • Visual Analog Scale (VAS) Pain Score

    Ten minutes after the procedure

Study Arms (2)

VIRTUAL REALITY GROUP

EXPERIMENTAL

Patients will undergo double j stent removal while wearing virtual reality glasses for distraction.

Other: Virtual Reality Distraction

CONTROL GROUP

ACTIVE COMPARATOR

Patients will undergo standart double j stent removal without any virtual reality intervention.

Other: Standart of care

Interventions

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

VIRTUAL REALITY GROUP

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

CONTROL GROUP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trabozn University Faculty of Medicine Kanuni Education and Research Hospital

Trabzon, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 35397973BACKGROUND
  • Toraman 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.

    PMID: 38418943BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

VOLKAN ENES CELIK, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
UROLOGY RESIDENT

Study Record Dates

First Submitted

August 11, 2026

First Posted

September 4, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

September 4, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations