Shockwave LithotripsyNCT05645445
The Effect of Virtual Reality Application on Pain and Anxiety Level in Stone Crushing With Shock Waves: A Randomized Controlled Trial
A study testing virtual reality in people with Shockwave Lithotripsy and Pain, run by Duzce University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shockwave Lithotripsy, Pain, Anxiety
- What is being tested?
- virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2022to 15 Apr 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Shockwave Lithotripsy, Pain, Anxiety, Virtual Reality, Nursing
- Being tested
- virtual reality
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | 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. |
| virtual reality group | Experimental | 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. Receives: Device: virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start15 Dec 2022 (estimated)
- Primary completion15 Jun 2023 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shockwave LithotripsyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- meral Yıldırım Çetinkaya, PhD, Principal investigator, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645445
- Sponsor's protocol ID
- Meral3
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Application on Pain and Anxiety Level in Stone Crushing With Shock Waves: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05645445
- Acronym / sponsor ID
- Meral3
- Conditions
- Shockwave Lithotripsy, Pain, Anxiety, Virtual Reality, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 9 Dec 2022 (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 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –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. |
| virtual reality group | Experimental | Device: virtual realityThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 realitypatients 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. | Device | virtual reality group |
Primary outcome
pain levels
Time frame: one day
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.
anxiety
Time frame: one day
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- 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. This study is not recruiting at the moment.
meral Yıldırım Çetinkaya, PhD principal investigator
Duzce University
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality in people with Shockwave Lithotripsy and Pain, run by Duzce University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zülal Kütük (+905377737389, zulalkutuk81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain levels (time frame: one day). The study lists 2 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 9 Dec 2022.