ESWLESWLNCT06804928
Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During Extracorporeal Shock Wave Lithotripsy
A study testing Virtual Reality Glasses in people with ESWL and Anxiety, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During ESWL Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Virtual Reality Glasses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- being 18 years of age or older,
- scheduled for elective ESWL due to renal or ureteral calculi,
- being conscious and able to communicate,
- voluntarily participated in the study after providing written informed consent,
- absence of coagulopathy or bleeding disorders,
- having a single radiopaque renal or ureteral calculus measuring ≤ 10 mm in diameter.
Who cannot join
- visual or auditory impairments preventing the use of virtual reality glasses,
- psychiatric or neurological disorders that could interfere with perception of the intervention,
- a diagnosis of epilepsy,
- the presence of multiple renal or ureteral calculi,
- abdominal arterial aneurysm, urinary diversion or urinary obstruction,
- the use of any sedatives or anxiolytics before or during the procedure.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Gazi State Hospital
Samsun, Merkez, 55070
About this study
Official title: Investigation of the Effect of Virtual Reality Glasses Used During Extracorporeal Shock Wave Lithotripsy (ESWL) on Patients' Pain, Anxiety, and Comfort Levels: A Randomized Controlled
Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During ESWL
- Conditions
- ESWL, Anxiety, Pain, Comfort, Virtual Reality
- Being tested
- Virtual Reality Glasses
- 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 GlassesBehavioural
Also called Control group
During the procedure, the patient will wear virtual reality glasses and watch a video. The video will be played through the virtual reality glasses throughout the entire procedure.
| Study group | Role | What they receive |
|---|---|---|
| VR-G (Virtual Reality Group) (1) | Experimental | During the procedure, the patient will wear virtual reality glasses and watch a video. The video will be played through the virtual reality glasses throughout the entire procedure. Receives: Behavioral: Virtual Reality Glasses |
| Control Group (2) | No intervention | No intervention will be applied to the patients in the control group, and the standard care protocol of the clinic will be followed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Pain levels will be assessed.
Measured: Data will be collected 10 minutes before the procedure.
Visual Anxiety Scale (VAS-A)
Anxiety levels will be assessed.
Measured: Data will be collected 10 minutes before the procedure.
Visual Comfort Scale
Comfort levels will be assessed.
Measured: Data will be collected 10 minutes before the procedure.
Spielberger Trait Anxiety Inventory (STAI-II)
It will be used to measure trait anxiety levels before the procedure.
Measured: The measurement will be conducted only once, 10 minutes before the procedure.
VAS
Pain levels will be assessed.
Measured: Data will be collected 30 minutes after the procedure.
Visual Anxiety Scale (VAS-A)
Anxiety levels will be assessed.
Measured: Data will be collected 30 minutes after the procedure.
Visual Comfort Scale
Comfort levels will be assessed.
Measured: Data will be collected 30 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 posted3 Feb 2025
- Study start1 Feb 2025
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESWLStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Cansu Yeniğün, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804928
- Sponsor's protocol ID
- Scansuscansu92
- Acronym
- ESWL
- Status last verified
- Nov 2025
- First submitted
- 28 Jan 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Virtual Reality Glasses Used During Extracorporeal Shock Wave Lithotripsy (ESWL) on Patients' Pain, Anxiety, and Comfort Levels: A Randomized Controlled
- ClinicalTrials.gov ID
- NCT06804928
- Acronym / sponsor ID
- ESWL / Scansuscansu92
- Conditions
- ESWL, Anxiety, Pain, Comfort, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 3 Feb 2025 (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.
Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During ESWL
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-G (Virtual Reality Group) (1) | Experimental | Behavioral: Virtual Reality GlassesDuring the procedure, the patient will wear virtual reality glasses and watch a video. The video will be played through the virtual reality glasses throughout the entire procedure. |
| Control Group (2) | No intervention | –No intervention will be applied to the patients in the control group, and the standard care protocol of the clinic will be followed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- being 18 years of age or older,
- scheduled for elective ESWL due to renal or ureteral calculi,
- being conscious and able to communicate,
- voluntarily participated in the study after providing written informed consent,
- absence of coagulopathy or bleeding disorders,
Key exclusion criteria (6 listed)
- visual or auditory impairments preventing the use of virtual reality glasses,
- psychiatric or neurological disorders that could interfere with perception of the intervention,
- a diagnosis of epilepsy,
- the presence of multiple renal or ureteral calculi,
- abdominal arterial aneurysm, urinary diversion or urinary obstruction,
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 GlassesAlso: Control groupDuring the procedure, the patient will wear virtual reality glasses and watch a video. The video will be played through the virtual reality glasses throughout the entire procedure. | Behavioural | VR-G (Virtual Reality Group) (1) |
Primary outcome
VAS
Time frame: Data will be collected 10 minutes before the procedure.
Pain levels will be assessed.
Visual Anxiety Scale (VAS-A)
Time frame: Data will be collected 10 minutes before the procedure.
Anxiety levels will be assessed.
Visual Comfort Scale
Time frame: Data will be collected 10 minutes before the procedure.
Comfort levels will be assessed.
Spielberger Trait Anxiety Inventory (STAI-II)
Time frame: The measurement will be conducted only once, 10 minutes before the procedure.
It will be used to measure trait anxiety levels before the procedure.
VAS
Time frame: Data will be collected 30 minutes after the procedure.
Pain levels will be assessed.
Visual Anxiety Scale (VAS-A)
Time frame: Data will be collected 30 minutes after the procedure.
Anxiety levels will be assessed.
Visual Comfort Scale
Time frame: Data will be collected 30 minutes after the procedure.
Comfort levels will be assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for ESWL
Not yet recruitingPhase 4
A Study on the Efficacy and Safety of Ningmitai Capsules in Treating Patients With Upper Urinary Tract Stones After Extracorporeal Shock Wave Lithotripsy
Calculus of Upper Urinary Tract
RecruitingObservational study
Renal Stone Treatment Global Registry
Urolithiasis
Recruiting
Acupressure as Complementary Analgesia in Shock Wave Lithotripsy
Acupressure, Urinary Calculi
Recruiting
Endotherapy and/or Extracorporeal Shockwave Lithotripsy for Painless Chronic Pancreatitis
Painless Chronic Pancreatitis
Not yet recruitingPhase 4
Pain Control During ESWL Using Non-Opioid Analgesics
Urolithiasis, Kidney Stones
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Glasses in people with ESWL and Anxiety, run by Akdeniz University 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 18 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: Data will be collected 10 minutes before the procedure.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2026.