CystoscopyNCT07359794
The Effect of Virtual Reality and Binaural Beats on Pain, Anxiety, and Vital Signs During Cystoscopy
A study testing Virtual reality headset and binaural beat listening in people with Cystoscopy and Binaural Beats, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a randomized controlled trial to evaluate the effect of nature videos viewed through virtual reality goggles and binaural beat audio played during cystoscopy on pain, anxiety, and vital signs. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cystoscopy, Binaural Beats, Virtual Reality
- What is being tested?
- Virtual reality headset and binaural beat listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 30 Dec 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 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 18 years of age or older,
- Male (Due to the shorter and straighter urethra in women and the procedure causing less discomfort, sampling is only included for male patients.),
- Planned for diagnostic or therapeutic rigid cystoscopy,
- Undergoing cystoscopy for the first time,
- Undergoing a cystoscopy procedure that does not require anesthesia,
- Without any condition that prevents communication,
Show all 9Show fewer
- Without any visual impairment or condition that prevents the use of VR glasses,
- Without mental disability or cognitive impairment,
- Individuals who volunteered to participate in the study were included in the study.
Who cannot join
- • Patients with contraindications for cystoscopy (allergic to lidocaine or other agents used, active urinary tract infection, anatomical problems related to the urethra)
- Patients who have used analgesic (painkiller) medication within 24 hours prior to cystoscopy
- Patients who will undergo additional manipulation during cystoscopy (Double J catheter placement or removal, bladder biopsy)
- Patients who did not comply with the study process and conditions were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Binaural Drumbeat Listening With Virtual Reality Goggles During Cystoscopy on Pain, Anxiety and Vital Signs
This study was conducted as a randomized controlled trial to evaluate the effect of nature videos viewed through virtual reality goggles and binaural beat audio played during cystoscopy on pain, anxiety, and vital signs. The study was conducted between September 2025 and December 2025 with 60 patients who applied to the cystoscopy unit of a public hospital in Istanbul and met the inclusion criteria. Patients in the experimental group (n=30) were shown nature videos using virtual reality goggles and listened to binaural beats through headphones, while patients in the control group (n=30) received no intervention other than routine care. Research data were collected using the Patient Introduction Form, Visual Analog Scale, State Anxiety Scale, and Vital Findings Form.
It was determined that nature videos and binaural beats played through virtual reality goggles during cystoscopy reduced patients' pain and anxiety levels and positively affected their vital signs.
Read the detailed description
Although cystoscopy is a short procedure performed under local anesthesia, its invasive nature can cause pain, anxiety, and physiological stress responses in patients. This can negatively affect the patient's compliance and overall comfort during the procedure. In recent years, it has been reported that distracting, non-pharmacological, and technology-based applications in surgical and interventional procedures are effective in increasing patient comfort. This study was planned and conducted as a randomized controlled trial to evaluate the effect of nature videos viewed through virtual reality (VR) goggles and binaural beats listened to simultaneously during cystoscopy on patients' pain levels, anxiety levels, and vital signs.The study was conducted between September 2025 and December 2025 at the cystoscopy unit of a public hospital in Istanbul. A total of 60 patients scheduled for cystoscopy and meeting the inclusion criteria were enrolled in the study. Patients were randomly assigned to either the experimental (n=30) or control (n=30) group. Patients in the experimental group were shown nature-themed videos through virtual reality glasses and listened to binaural beats through headphones before and during the cystoscopy procedure. No additional interventions were performed on patients in the control group other than the routine care protocol applied in the clinic. Research data were collected using the Patient Introduction Form, which included patient characteristics; the Visual Analog Scale (VAS) to assess pain levels; the State Anxiety Scale to determine anxiety levels; and the Vital Signs Form, which included systolic-diastolic blood pressure, pulse, and respiratory rate. Measurements were taken before, during, and after the procedure.
The research results show that nature videos and binaural beats played through virtual reality goggles during cystoscopy are an effective intervention in reducing patients' pain and anxiety levels and positively affecting physiological parameters. Due to its non-invasive, low-cost, and easy-to-implement nature, this combination is considered to be a complementary nursing practice that can be integrated into clinical applications to enhance patient comfort during short-term procedures such as cystoscopy.
- Conditions
- Cystoscopy, Binaural Beats, Virtual Reality
- Being tested
- Virtual reality headset and binaural beat listening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headset and binaural beat listeningOther
Nature video and binaural drumming experience with virtual reality headset
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality and binaural beat | Experimental | Before cystoscopy During cystoscopy After cystoscopy Receives: Other: Virtual reality headset and binaural beat listening |
| Standard care | No intervention | Before cystoscopy During cystoscopy After cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of VR and Binaural Beats on Anxiety
State Anxiety Inventory: In this study, the "State Anxiety Inventory (STAI-I)" will be used before and after the mandala coloring to assess patients' situational anxiety. The inventory evaluates how individuals feel at a particular moment. It includes 20 items, each scored from 1 (Not at all) to 4 (Completely), reflecting the intensity of the emotion experienced. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 are reverse scored. Total scores range from 20 to 80; higher scores indicate greater anxiety. Additionally, the "Trait Anxiety Inventory (STAI-II)" measures general anxiety independent of specific situations, using a similar 20-item structure with frequency-based responses. The full inventory contains 40 items. High scores on either scale indicate higher anxiety levels.Patients completed the questionnaire before and after cystoscopy.
Measured: 4 month
The Effect of VR and Binaural Beats on Pain
Visual Analog Scale: The Visual Analog Scale is a commonly used unidimensional measure for assessing pain intensity. The VAS is a measurement tool ranging from 0 to 10 cm (0 to 100 mm) in length.
Since the aim of the study is to determine the effect of the non-pharmacological method used on existing pain, VAS will be used to assess pain before, during, and after cystoscopy
Measured: 4 month
The Effect of VR and Binaural Beats on blood pressure
Patients' blood pressure values will be recorded. The effect of non-pharmacological interventions on patients' blood pressure values will be evaluated. Evaluated before, during, and after the cystoscopy
Measured: 4 month
The Effect of VR and Binaural Beats on pulse
Patients' pulse , values will be recorded. The effect of non-pharmacological interventions on patients' pulse values will be evaluated.Evaluated before, during, and after the cystoscopy
Measured: 4 month
The Effect of VR and Binaural Beats on oxygen saturation
Patients' oxygen saturation , values will be recorded. The effect of non-pharmacological interventions on patients' oxygen saturation values will be evaluated.Evaluated before, during, and after the cystoscopy
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Sep 2025
- Primary completion1 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CystoscopyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niran Çoban, University of Yalova
- Investigators
- NİRAN ÇOBAN, Study director, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359794
- Sponsor's protocol ID
- NK
- Status last verified
- Jul 2026
- First submitted
- 7 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xiong J, Jiang X, Cai B, Zhao L, Zhang Q, Luo J. Binaural beats for perioperative anxiety and pain: A systematic review and meta-analysis. Complement Ther Med. 2025 Dec;95:103299. doi: 10.1016/j.ctim.2025.103299. Epub 2025 Oct 30.
PubMed 41176178Tani A, Vagheggini G, Moretti F, Del Colombo V, Lehle J, Campana S, Labate A, Tomaiuolo F. Binaural Beats Reduce Postoperative Morphine Consumption in Older adults After Total Knee Replacement Surgery. Altern Ther Health Med. 2021 Mar;27(2):27-30.
PubMed 32412916Ligree N, Nanda S, Morwal S, Garg K. Effect of binaural beat music and noise cancelling headphones on intraoperative anxiety in patients undergoing spinal anaesthesia - A randomised controlled study. Indian J Anaesth. 2023 Jul;67(7):590-594. doi: 10.4103/ija.ija_740_22. Epub 2023 Jul 14.
PubMed 37601935Öner, N., Le Compte, A., Durumluk Sürekli Kaygı Envanteri El Kitabı, 2. Baskı, Boğaziçi Üniversitesi Yayınları, No:333, 1985.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Binaural Drumbeat Listening With Virtual Reality Goggles During Cystoscopy on Pain, Anxiety and Vital Signs
- ClinicalTrials.gov ID
- NCT07359794
- Acronym / sponsor ID
- NK
- Conditions
- Cystoscopy, Binaural Beats, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 22 Jan 2026 (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 study was conducted as a randomized controlled trial to evaluate the effect of nature videos viewed through virtual reality goggles and binaural beat audio played during cystoscopy on pain, anxiety, and vital signs. The study was conducted between September 2025 and December 2025 with 60 patients who applied to the cystoscopy unit of a public hospital in Istanbul and met the inclusion criteria. Patients in the experimental group (n=30) were shown nature videos using virtual reality goggles and listened to binaural beats through headphones, while patients in the control group (n=30) received no intervention other than routine care. Research data were collected using the Patient Introduction Form, Visual Analog Scale, State Anxiety Scale, and Vital Findings Form.
It was determined that nature videos and binaural beats played through virtual reality goggles during cystoscopy reduced patients' pain and anxiety levels and positively affected their vital signs.
Detailed description
Although cystoscopy is a short procedure performed under local anesthesia, its invasive nature can cause pain, anxiety, and physiological stress responses in patients. This can negatively affect the patient's compliance and overall comfort during the procedure. In recent years, it has been reported that distracting, non-pharmacological, and technology-based applications in surgical and interventional procedures are effective in increasing patient comfort. This study was planned and conducted as a randomized controlled trial to evaluate the effect of nature videos viewed through virtual reality (VR) goggles and binaural beats listened to simultaneously during cystoscopy on patients' pain levels, anxiety levels, and vital signs.The study was conducted between September 2025 and December 2025 at the cystoscopy unit of a public hospital in Istanbul. A total of 60 patients scheduled for cystoscopy and meeting the inclusion criteria were enrolled in the study. Patients were randomly assigned to either the experimental (n=30) or control (n=30) group. Patients in the experimental group were shown nature-themed videos through virtual reality glasses and listened to binaural beats through headphones before and during the cystoscopy procedure. No additional interventions were performed on patients in the control group other than the routine care protocol applied in the clinic. Research data were collected using the Patient Introduction Form, which included patient characteristics; the Visual Analog Scale (VAS) to assess pain levels; the State Anxiety Scale to determine anxiety levels; and the Vital Signs Form, which included systolic-diastolic blood pressure, pulse, and respiratory rate. Measurements were taken before, during, and after the procedure.
The research results show that nature videos and binaural beats played through virtual reality goggles during cystoscopy are an effective intervention in reducing patients' pain and anxiety levels and positively affecting physiological parameters. Due to its non-invasive, low-cost, and easy-to-implement nature, this combination is considered to be a complementary nursing practice that can be integrated into clinical applications to enhance patient comfort during short-term procedures such as cystoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality and binaural beat | Experimental | Other: Virtual reality headset and binaural beat listeningBefore cystoscopy During cystoscopy After cystoscopy |
| Standard care | No intervention | –Before cystoscopy During cystoscopy After cystoscopy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • 18 years of age or older,
Key exclusion criteria (4 listed)
- • Patients with contraindications for cystoscopy (allergic to lidocaine or other agents used, active urinary tract infection, anatomical problems related to the urethra)
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 headset and binaural beat listeningNature video and binaural drumming experience with virtual reality headset | Other | Virtual reality and binaural beat |
Primary outcome
The Effect of VR and Binaural Beats on Anxiety
Time frame: 4 month
State Anxiety Inventory: In this study, the "State Anxiety Inventory (STAI-I)" will be used before and after the mandala coloring to assess patients' situational anxiety. The inventory evaluates how individuals feel at a particular moment. It includes 20 items, each scored from 1 (Not at all) to 4 (Completely), reflecting the intensity of the emotion experienced. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 are reverse scored. Total scores range from 20 to 80; higher scores indicate greater anxiety. Additionally, the "Trait Anxiety Inventory (STAI-II)" measures general anxiety independent of specific situations, using a similar 20-item structure with frequency-based responses. The full inventory contains 40 items. High scores on either scale indicate higher anxiety levels.Patients completed the questionnaire before and after cystoscopy.
The Effect of VR and Binaural Beats on Pain
Time frame: 4 month
Visual Analog Scale: The Visual Analog Scale is a commonly used unidimensional measure for assessing pain intensity. The VAS is a measurement tool ranging from 0 to 10 cm (0 to 100 mm) in length. Since the aim of the study is to determine the effect of the non-pharmacological method used on existing pain, VAS will be used to assess pain before, during, and after cystoscopy
The Effect of VR and Binaural Beats on blood pressure
Time frame: 4 month
Patients' blood pressure values will be recorded. The effect of non-pharmacological interventions on patients' blood pressure values will be evaluated. Evaluated before, during, and after the cystoscopy
The Effect of VR and Binaural Beats on pulse
Time frame: 4 month
Patients' pulse , values will be recorded. The effect of non-pharmacological interventions on patients' pulse values will be evaluated.Evaluated before, during, and after the cystoscopy
The Effect of VR and Binaural Beats on oxygen saturation
Time frame: 4 month
Patients' oxygen saturation , values will be recorded. The effect of non-pharmacological interventions on patients' oxygen saturation values will be evaluated.Evaluated before, during, and after the cystoscopy
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 7 Jul 2026.
- Background: PubMed 41176178Xiong J, Jiang X, Cai B, Zhao L, Zhang Q, Luo J. Binaural beats for perioperative anxiety and pain: A systematic review and meta-analysis. Complement Ther Med. 2025 Dec;95:103299. doi: 10.1016/j.ctim.2025.103299. Epub 2025 Oct 30.
- Background: PubMed 32412916Tani A, Vagheggini G, Moretti F, Del Colombo V, Lehle J, Campana S, Labate A, Tomaiuolo F. Binaural Beats Reduce Postoperative Morphine Consumption in Older adults After Total Knee Replacement Surgery. Altern Ther Health Med. 2021 Mar;27(2):27-30.
- Background: PubMed 37601935Ligree N, Nanda S, Morwal S, Garg K. Effect of binaural beat music and noise cancelling headphones on intraoperative anxiety in patients undergoing spinal anaesthesia - A randomised controlled study. Indian J Anaesth. 2023 Jul;67(7):590-594. doi: 10.4103/ija.ija_740_22. Epub 2023 Jul 14.
- BackgroundÖner, N., Le Compte, A., Durumluk Sürekli Kaygı Envanteri El Kitabı, 2. Baskı, Boğaziçi Üniversitesi Yayınları, No:333, 1985.
- 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.
NİRAN ÇOBAN study director
University of Yalova
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 headset and binaural beat listening in people with Cystoscopy and Binaural Beats, run by University of Yalova 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 9 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: finished, as of the sponsor's last update on 7 Jul 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?
The Effect of VR and Binaural Beats on Anxiety (time frame: 4 month). The study lists 5 primary outcomes in all. 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 NCT07359794, which also lists 4 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 7 Jul 2026.