Extracorporeal Shock Wave LithotripsyNCT05842668
Effect of Virtual Glasses on Pain and Comfort During ESWL
A study testing ESWL Group in people with Extracorporeal Shock Wave Lithotripsy and Lithotripsy, run by Akdeniz University.
Trial summary
The aim of this study is to examine the effect of virtual glasses application on the patient's pain and comfort level during ESWL. The data obtained in the research will be analyzed using the SPSS 23.0 "Statistical Package for Social Sciences" for Windows program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Extracorporeal Shock Wave Lithotripsy, Lithotripsy
- What is being tested?
- ESWL Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 16 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older,
- Absence of hearing and perception problems,
- Absence of any visual impairment,
- ESWL procedure will be performed for the first time,
Who cannot join
- Using any analgesic or anxiolytic before the procedure,
- Having a psychiatric disorder
About this study
Official title: Investigation of the Effect of Virtual Glasses Used During Extracorporeal Shock Wave Lithotripsy-ESWL on Patient's Pain and Comfort Level: A Randomized Controlled Study
The aim of this study is to examine the effect of virtual glasses application on the patient's pain and comfort level during ESWL.
The data obtained in the research will be analyzed using the SPSS 23.0 "Statistical Package for Social Sciences" for Windows program. Descriptive statistical methods when evaluating data; number, percentage, mean, frequency, standard deviation will be used. As hypothesis tests, analysis will be made with Mann Whitney U, student t test, and chi-square tests. The findings will be interpreted with a significance level of 0.05 at the 95% confidence interval.
Read the detailed description
After obtaining the permission of the ethics committee and institution of the study, the researcher will go to the clinic and introduce himself to the patient who is admitted to undergo ESWL procedure and explain the purpose of the research. Informed consent will be obtained from patients who volunteered to participate in the study. The data on the socio-demographic characteristics of the patients in the patient introduction form will be interviewed face-to-face with the patient, and the data on the clinical characteristics of the patients will be recorded from the patient file. Data will be collected from the first patient who will undergo the ESWL procedure. Pain with VAS and comfort level with General comfort scale will be checked 5-10 minutes before the procedure. According to the randomization, the patient in the virtual glasses group will first be explained to the patient by the researcher that he will wear the glasses for 30 minutes during the procedure and watch the video. When the 30 minutes are up, the patient will be informed by the researcher and the glasses will be removed. No intervention will be performed on the patient in the control group. The first patient will go to the operation room. Patients in the virtual glasses group will use the virtual glasses for 30 minutes after the patient goes to the operating table and the preparation is completed. No intervention will be performed on the patient in the control group. All patient groups will be checked for pain with VAS and comfort level with general comfort scale 30 minutes after the end of the procedure. At the end of the procedure, the patient will come to the service. No intervention will be done to the patients in the control group, and the routine care protocol of the clinic will be applied.
- Conditions
- Extracorporeal Shock Wave Lithotripsy, Lithotripsy
- Being tested
- ESWL Group
- Keywords
- ESWL, Pain, comfort level, virtual glasses
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWL GroupBehavioural
Increasing comfort and reducing pain during ESWL
| Study group | Role | What they receive |
|---|---|---|
| ESWL Group | Experimental | Not described Receives: Behavioral: ESWL Group |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort Score
The response patterns of the scale, which consists of positive and negative items, are given in a mixed form. A high score for positive items (4) indicates high comfort, a low score (1) indicates low comfort, and a low score (1 point) for negative items indicates high comfort, and a high score (4 points) indicates low comfort. While evaluating the scale, the negative scores obtained are reverse coded and added together with the positive items. The maximum total score that can be obtained from the scale is 192, and the minimum total score is 48.
Measured: 5-10 minutes before ESWL
Pain Score (Visual analog Score)
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain.
The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain.
In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Measured: 5-10 minutes before ESWL
Secondary outcomes (2)
Comfort Score
The response patterns of the scale, which consists of positive and negative items, are given in a mixed form. A high score for positive items (4) indicates high comfort, a low score (1) indicates low comfort, and a low score (1 point) for negative items indicates high comfort, and a high score (4 points) indicates low comfort. While evaluating the scale, the negative scores obtained are reverse coded and added together with the positive items. The maximum total score that can be obtained from the scale is 192, and the minimum total score is 48.
Measured: 15 minutes after ESWL
Pain Score (Visual analog Score)
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain.
The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain.
In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Measured: 15 minutes after ESWL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion16 Mar 2024 (estimated)
Why it stopped: The run could not be started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Shock Wave LithotripsyStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Seda Cansu Yeniğün, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842668
- Sponsor's protocol ID
- Lecturer-11412
- Status last verified
- Aug 2025
- First submitted
- 20 Apr 2023
- Last updated
- 26 Aug 2025
- 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 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Virtual Glasses Used During Extracorporeal Shock Wave Lithotripsy-ESWL on Patient's Pain and Comfort Level: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05842668
- Acronym / sponsor ID
- Lecturer-11412
- Conditions
- Extracorporeal Shock Wave Lithotripsy, Lithotripsy
- Keywords
- ESWL, Pain, comfort level, virtual glasses
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The run could not be started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 16 Mar 2024 (estimated)
- First posted
- 6 May 2023 (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.
The aim of this study is to examine the effect of virtual glasses application on the patient's pain and comfort level during ESWL.
The data obtained in the research will be analyzed using the SPSS 23.0 "Statistical Package for Social Sciences" for Windows program. Descriptive statistical methods when evaluating data; number, percentage, mean, frequency, standard deviation will be used. As hypothesis tests, analysis will be made with Mann Whitney U, student t test, and chi-square tests. The findings will be interpreted with a significance level of 0.05 at the 95% confidence interval.
Detailed description
After obtaining the permission of the ethics committee and institution of the study, the researcher will go to the clinic and introduce himself to the patient who is admitted to undergo ESWL procedure and explain the purpose of the research. Informed consent will be obtained from patients who volunteered to participate in the study. The data on the socio-demographic characteristics of the patients in the patient introduction form will be interviewed face-to-face with the patient, and the data on the clinical characteristics of the patients will be recorded from the patient file. Data will be collected from the first patient who will undergo the ESWL procedure. Pain with VAS and comfort level with General comfort scale will be checked 5-10 minutes before the procedure. According to the randomization, the patient in the virtual glasses group will first be explained to the patient by the researcher that he will wear the glasses for 30 minutes during the procedure and watch the video. When the 30 minutes are up, the patient will be informed by the researcher and the glasses will be removed. No intervention will be performed on the patient in the control group. The first patient will go to the operation room. Patients in the virtual glasses group will use the virtual glasses for 30 minutes after the patient goes to the operating table and the preparation is completed. No intervention will be performed on the patient in the control group. All patient groups will be checked for pain with VAS and comfort level with general comfort scale 30 minutes after the end of the procedure. At the end of the procedure, the patient will come to the service. No intervention will be done to the patients in the control group, and the routine care protocol of the clinic will be applied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWL Group | Experimental | Behavioral: ESWL Group |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older,
- Absence of hearing and perception problems,
- Absence of any visual impairment,
- ESWL procedure will be performed for the first time,
Key exclusion criteria (2 listed)
- Using any analgesic or anxiolytic before the procedure,
- Having a psychiatric disorder
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 |
|---|---|---|
| ESWL GroupIncreasing comfort and reducing pain during ESWL | Behavioural | ESWL Group |
Primary outcome
Comfort Score
Time frame: 5-10 minutes before ESWL
The response patterns of the scale, which consists of positive and negative items, are given in a mixed form. A high score for positive items (4) indicates high comfort, a low score (1) indicates low comfort, and a low score (1 point) for negative items indicates high comfort, and a high score (4 points) indicates low comfort. While evaluating the scale, the negative scores obtained are reverse coded and added together with the positive items. The maximum total score that can be obtained from the scale is 192, and the minimum total score is 48.
Pain Score (Visual analog Score)
Time frame: 5-10 minutes before ESWL
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
2 secondary outcomes
Comfort Score
Time frame: 15 minutes after ESWL
Pain Score (Visual analog Score)
Time frame: 15 minutes after ESWL
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ESWL Group in people with Extracorporeal Shock Wave Lithotripsy and Lithotripsy, run by Akdeniz 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 2 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: withdrawn, as of the sponsor's last update on 26 Aug 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Comfort Score (time frame: 5-10 minutes before ESWL). 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 26 Aug 2025.