- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07359794
The Effect of Virtual Reality and Binaural Beats on Pain, Anxiety, and Vital Signs During Cystoscopy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Yalova, Turkey (Türkiye), 34959
- Yalova University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 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,
- 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.
Exclusion Criteria:
• 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual reality and binaural beat
Before cystoscopy During cystoscopy After cystoscopy
|
Nature video and binaural drumming experience with virtual reality headset
|
|
No Intervention: Standard care
Before cystoscopy During cystoscopy After cystoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 month
|
|
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 |
4 month
|
|
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
|
4 month
|
|
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
|
4 month
|
|
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
|
4 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: NİRAN ÇOBAN, University of Yalova
Publications and helpful links
General Publications
- Tani 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.
- Ligree 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.
- 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.
- Öner, N., Le Compte, A., Durumluk Sürekli Kaygı Envanteri El Kitabı, 2. Baskı, Boğaziçi Üniversitesi Yayınları, No:333, 1985.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Virtual Reality
-
The Cleveland ClinicRecruitingEndoscopy | Virtual Reality | Ergonomics | Virtual Reality HeadsetUnited States
-
Royal National Orthopaedic Hospital NHS TrustNot yet recruitingVirtual Reality | Education, Medical | Virtual Reality Simulation
-
Cairo UniversityCompletedVirtual Reality | Pediatric Burn | Immersive Virtual Reality | Passive Virtual RealityEgypt
-
Stanford UniversityRecruitingVirtual Reality | Augmented RealityUnited States
-
National Taiwan University HospitalRecruiting
-
National Taiwan University HospitalNot yet recruiting
-
Charles River AnalyticsNational Institute of Environmental Health Sciences (NIEHS); The New England...Completed
-
Ardahan UniversityCompleted
-
The Methodist Hospital Research InstituteNational Institute on Aging (NIA)CompletedVirtual RealityUnited States
Clinical Trials on Virtual reality headset and binaural beat listening
-
University of BaghdadCompletedHeart Valve Diseases | Sleep Disturbances | Postoperative DiscomfortIraq
-
Dartmouth-Hitchcock Medical CenterNot yet recruiting
-
University of California, DavisCompleted
-
University Health Network, TorontoMichael Garron Hospital; Centre for Aging and Brain Health InnovationTerminatedDementia | Delirium Superimposed on DementiaCanada
-
Ruhr University of BochumCompletedPain | Anxiety | Cervical DysplasiaGermany
-
Fondazione Policlinico Universitario Agostino Gemelli...Completed
-
University of SevilleNot yet recruiting
-
Istituto Ortopedico RizzoliRecruitingPreoperative AnxietyItaly
-
Koç UniversityCompletedPain | Anxiety | Virtual Reality | Coronary Angiography (CAG)Turkey (Türkiye)
-
Serap Ozturk AltinayakCompletedPain | AnxietyTurkey (Türkiye)