Pain ManagementNCT06629727
The Effect Of Virtual Reality Glasses On Pain And Anxiety During The Kidney Stone Lithotripsy Procedure
A study testing VR Group in people with Pain Management and Extracorporeal Shock Wave Lithotripsy, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
To determine the pain and anxiety levels of patients using virtual reality glasses during the extracorporeal shock wave lithotripsy procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management, Extracorporeal Shock Wave Lithotripsy, Virtual Reality
- What is being tested?
- VR Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2021to 10 Nov 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Performing ESWL procedure
Who cannot join
- Presence of psychiatric disease
- Vision problem
- Hearing problem
- Drug and alcohol addiction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Virtual Realty Glasses On Pain And Anxiety During The Kidney Stone Lithotripsy Procedure
To determine the pain and anxiety levels of patients using virtual reality glasses during the extracorporeal shock wave lithotripsy procedure.
Read the detailed description
This randomized clinical trial included 60 patients with lithotripsy procedure. The research group of 60 people was divided into two groups, 30 in the experimental group and 30 in the control group. While the standard stone crushing process was applied to the control group, the experimental group was watched with virtual reality glasses during the procedure. The State-Trait Anxiety Inventory and the Numerical Rating Scale, which was used to measure the level of pain and anxiety level.
- Being tested
- VR Group, Control group
- Keywords
- extracorporeal shock wave lithotripsy, pain, Virtual reality, Anxiety
- Medical subject headings
- Agnosia, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR GroupOther
the experimental group was shown a video through VRG during the lithotripsy procedure.
Control groupOther
Patients received standard care during the procedure
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | Use of VR glasses during the procedure Receives: Other: VR Group |
| Control Group | Active comparator | Standart care group Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Scale
Pain level during the procedure
Measured: During ESWL procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start25 Jul 2021
- Primary completion10 Feb 2022
- Study completion10 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Gunes, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629727
- Sponsor's protocol ID
- Istanbul Beykent University
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This was a masters thesis research, and the computer used to collect data at that time was damaged. Communication could not be established with the statistician who conducted the data analysis.
Publications
Guitynavard F, Azadvari M, Gholamnejad M, et al. Decreasing discomfort during shock-wave lithotripsy using transcutaneous electrical nerve stimulation. Translational Research in Urology. 2022; 4(2): 71-76
Lei M, Li G, Tang Y, Yuan J, Yang T, Gao Z. Efficacy of music therapy for pain control of extracorporeal shock wave lithotripsy: A meta-analysis of randomized controlled studies. Medicine (Baltimore). 2024 May 31;103(22):e38182. doi: 10.1097/MD.0000000000038182.
PubMed 39259054Ozsaker E, Diramali A. The effect of transcutaneous electrical nerve stimulation for pain relief during extracorporeal shock-wave lithotripsy procedure. Pain Manag Nurs. 2014 Mar;15(1):59-68. doi: 10.1016/j.pmn.2012.06.003. Epub 2012 Aug 18.
PubMed 24602425
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Virtual Realty Glasses On Pain And Anxiety During The Kidney Stone Lithotripsy Procedure
- ClinicalTrials.gov ID
- NCT06629727
- Acronym / sponsor ID
- Istanbul Beykent University
- Keywords
- extracorporeal shock wave lithotripsy, pain, Virtual reality, Anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Nov 2024 (estimated)
- First posted
- 8 Oct 2024 (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.
To determine the pain and anxiety levels of patients using virtual reality glasses during the extracorporeal shock wave lithotripsy procedure.
Detailed description
This randomized clinical trial included 60 patients with lithotripsy procedure. The research group of 60 people was divided into two groups, 30 in the experimental group and 30 in the control group. While the standard stone crushing process was applied to the control group, the experimental group was watched with virtual reality glasses during the procedure. The State-Trait Anxiety Inventory and the Numerical Rating Scale, which was used to measure the level of pain and anxiety level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Other: VR GroupUse of VR glasses during the procedure |
| Control Group | Active comparator | Other: Control groupStandart care group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Performing ESWL procedure
Key exclusion criteria (4 listed)
- Presence of psychiatric disease
- Vision problem
- Hearing problem
- Drug and alcohol addiction
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 |
|---|---|---|
| VR Groupthe experimental group was shown a video through VRG during the lithotripsy procedure. | Other | VR group |
| Control groupPatients received standard care during the procedure | Other | Control Group |
Primary outcome
Numeric Pain Scale
Time frame: During ESWL procedure
Pain level during the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Results publicationGuitynavard F, Azadvari M, Gholamnejad M, et al. Decreasing discomfort during shock-wave lithotripsy using transcutaneous electrical nerve stimulation. Translational Research in Urology. 2022; 4(2): 71-76
- Results publication: PubMed 39259054Lei M, Li G, Tang Y, Yuan J, Yang T, Gao Z. Efficacy of music therapy for pain control of extracorporeal shock wave lithotripsy: A meta-analysis of randomized controlled studies. Medicine (Baltimore). 2024 May 31;103(22):e38182. doi: 10.1097/MD.0000000000038182.
- Results publication: PubMed 24602425Ozsaker E, Diramali A. The effect of transcutaneous electrical nerve stimulation for pain relief during extracorporeal shock-wave lithotripsy procedure. Pain Manag Nurs. 2014 Mar;15(1):59-68. doi: 10.1016/j.pmn.2012.06.003. Epub 2012 Aug 18.
- The effect of transcutaneous electrical nerve stimulation for pain relief during extracorporeal shock-wave lithotripsy procedure.Link provided by the sponsor.
- Impact of music on anxiety and pain control during extracorporeal shockwave lithotripsy: A protocol for systematic review and meta-analysis.Link provided by the sponsor.
- Individual participant dataSharing planned: No. This was a masters thesis research, and the computer used to collect data at that time was damaged. Communication could not be established with the statistician who conducted the data analysis.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Group in people with Pain Management and Extracorporeal Shock Wave Lithotripsy, run by University of Beykent 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 1 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Numeric Pain Scale (time frame: During ESWL procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06629727, which also lists 3 linked publications.
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 8 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.