CClinicalTrials.gg
Status unknownNCT05645445Updated Dec 9, 2022

The Effect of Virtual Reality Application on Pain and Anxiety Level in Stone Crushing With Shock Waves: A Randomized Controlled Trial

An interventional study of virtual reality in Shockwave Lithotripsy, Pain and Anxiety, sponsored by Duzce University. Status unknown. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-09.

Sponsored by Duzce University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This research was planned as a randomized controlled experimental study in order to evaluate the effect of virtual reality application on pain and anxiety caused by the procedure during stone crushing process (ESWL) with shock waves.

Read the detailed description

Although urinary tract stones often remain asymptomatic at first, they can cause pain, hematuria, infection, decreased kidney function and kidney failure over time and can seriously affect the quality of life of people if not treated with appropriate methods.

Extracorporeal shockwave lithotripsy (ESWL) has been practiced as a treatment method to remove urolithiasis from the kidneys and ureters since the early 1980s.

The process is based on the principle that the sound waves obtained from a source other than the body are turned into shock waves and sent to the stone and the stone is broken down.

Relief of pain and anxiety during ESWL; In addition to maintaining patient comfort and satisfaction, it is extremely important to reduce the movement of the patient during the procedure and to facilitate the imaging and targeting of the stone.

Diverting attention is one of the most preferred methods to reduce the pain that occurs in patients while the diagnosis and treatment procedures are carried out. This method; It is a method that focuses the attention of patients on a different point and keeps the symptoms they experience under control and reduces them.

Strategies to divert attention include the application of virtual reality, which has been one of the methods that have attracted attention in recent years.

The individual focuses his attention on the image by moving away from real life with the glasses connected to the device worn on his head and the sounds coming from the headphones and feels as if he is in a different world thanks to these glasses.

In practice, it is aimed to reduce the patient's pain, discomfort and anxiety by drawing the patient's attention from pain and painful treatment procedures to a fun virtual environment.

02

Conditions studied

  • Shockwave Lithotripsy
  • Pain
  • Anxiety
  • Virtual Reality
  • Nursing

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03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's planned enrollment of 72 is close to the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Duzce University is the lead sponsor of 70 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Applying to the stone crushing unit for the first time
  • Body mass index below 30
  • Those aged 18-65 who are literate and have no vision or hearing problems
  • Have not taken any analgesics other than the analgesic routinely administered before the procedure

Exclusion criteria

Exclusion Criteria:

  • Untreated urinary tract infections
  • Severe skeletal system malformations that prevent focusing on the stone
  • Severe obesity
  • Arterial aneurysm near the stone
  • Patients with anatomical obstruction conditions in the distal part of the stone
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • No intervention
    control group

    The routine ESWL procedure will be applied. Pre-procedural anxieties will be evaluated with the State-Trait Anxiety Inventory-State Anxiety Scale. After the ESWL procedure, their anxiety will be re-evaluated with the same scale, and their pain will also be evaluated with the Visual Analog Scale.

  • Experimental
    virtual reality group

    The pre-procedure anxiety of the patients who will use virtual reality glasses during the ESWL process will be evaluated with the State-Trait Anxiety Inventory-State Anxiety Score. After the ESWL procedure, their anxiety will be re-evaluated with the same scale and in addition to the pain, the pain will be evaluated with the Visual Analog Scale.

    Device: virtual reality

Interventions

  • Devicevirtual reality

    patients who include intervention gruop during the ESWL process, patients will be shown videos with virtual reality glasses, which include nature and landscapes, giving people a feeling of comfort and peace, and making them feel like they are inside.

06

What researchers measure

Primary outcomes

  1. pain levels

    pain measurement will be made by visual analog scale (VAS). The intensity will measure the area in which the individual mark between 0 (no pain) and 10 (worst pain i felt my life). The pain level will be asked one times before the shockwave process.

    Time frame: one day

  2. anxiety

    Anxiety levels will be measure by the State-Trait Anxiety Inventory-State Anxiety (STAI-SA). The STAI scores were calculated based on the patients' answers. The overall score ranges from 20-80 and the higher the score indicates the higher the anxiety level. Patients with the STAI scores of 35 or lower were considered as having 'no anxiety' while patients with scores of 42 or higher were considered as 'severely anxious' as recommended by the practice guidelines. The survey will be used before and after shockwave for measure the anxiety levels in two groups.

    Time frame: one day

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05645445
Lead sponsor
Duzce University
Responsible party
Sponsor
First posted
Dec 9, 2022
Start date
Dec 15, 2022 (estimated)
Primary completion
Jun 15, 2023 (estimated)
Completion
Apr 15, 2024 (estimated)
Last update
Dec 9, 2022

Study contacts

Zülal Kütük
Contact
zulalkutuk81@gmail.com
+905377737389
meral Yıldırım Çetinkaya, PhD
Contact
meralyildirim@duzce.edu.tr
+905366295020
meral Yıldırım Çetinkaya, PhD
principal investigator · Duzce University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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