An observational study in Procedural Pain, Anxiety and Pain During Cystoscopy, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Saglik Bilimleri Universitesi · Observational
This prospective, single-center, three-group clinical study aims to evaluate the effects of binaural beat stimulation on pain and anxiety in adult patients undergoing flexible cystoscopy.
A total of 120 patients aged 18 to 80 years are planned to be included. Participants will be evaluated in three groups according to the auditory stimulation received during flexible cystoscopy: 5 Hz theta binaural beats (n = 40), 10 Hz alpha binaural beats (n = 40), and a control group without binaural beat stimulation (n = 40).
The primary outcome will be pain intensity during flexible cystoscopy, assessed using the Visual Analog Scale (VAS). Secondary outcomes will include anxiety levels measured using the State-Trait Anxiety Inventory-State (STAI-S) before and after the procedure, as well as patient comfort and satisfaction.
The study aims to determine whether binaural beat stimulation may provide a simple, non-invasive approach to improving patient comfort during flexible cystoscopy.
Flexible cystoscopy is a commonly performed urological procedure used for the diagnosis and follow-up of various lower urinary tract conditions. Although generally well tolerated, some patients experience pain, discomfort, and anxiety during the procedure. Non-pharmacological approaches, including auditory stimulation, may help improve patient comfort.
Binaural beat stimulation is an auditory technique in which slightly different sound frequencies are delivered separately to each ear, creating the perception of a rhythmic beat. Theta-frequency binaural beats (4-7 Hz) and alpha-frequency binaural beats (8-12 Hz) have been investigated for their potential effects on relaxation, anxiety, and pain perception.
This prospective, single-center study will be conducted at the Department of Urology, Kulu State Hospital, Konya, Türkiye. A total of 120 adult patients aged 18-80 years who are scheduled to undergo flexible cystoscopy for diagnostic or follow-up purposes will be included.
Participants will be evaluated in three groups according to the type of auditory stimulation received:
Group 1: Theta binaural beat stimulation at 5 Hz (approximately 40 participants).
Group 2: Alpha binaural beat stimulation at 10 Hz (approximately 40 participants).
Group 3: Control group without binaural beat stimulation (approximately 40 participants).
All flexible cystoscopy procedures will be performed according to routine clinical practice. Binaural beat stimulation will be delivered through headphones without requiring any additional invasive procedure.
Before flexible cystoscopy, demographic and clinical characteristics will be recorded, and baseline anxiety will be assessed using the State-Trait Anxiety Inventory-State (STAI-S). Following the procedure, participants will report the pain experienced during cystoscopy using the Visual Analog Scale (VAS). Anxiety will be reassessed using the STAI-S. Additional assessments will include procedure duration, patient comfort, and satisfaction.
The primary outcome will be pain intensity assessed by VAS. Secondary outcomes will include preprocedural and postprocedural STAI-S scores, changes in anxiety levels, and patient-reported comfort and satisfaction.
The sample size was determined using G*Power software. A total of 120 participants, with approximately 40 participants in each group, is planned.
Between-group comparisons will be performed using appropriate parametric or nonparametric statistical tests depending on data distribution. Within-group changes in anxiety scores will also be analyzed. Statistical significance will be defined as p \< 0.05.
The study aims to investigate whether theta- or alpha-frequency binaural beat stimulation is associated with reduced pain and anxiety during flexible cystoscopy and whether these approaches may improve patient comfort.
242 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's enrollment of 120 is below the median of 190 across 14 observational studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Saglik Bilimleri Universitesi is the lead sponsor of 447 studies on the registry; 138 are open to participants now.
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The study population will consist of 120 adult patients aged 18 to 80 years who are scheduled to undergo flexible cystoscopy for diagnostic or follow-up purposes at the Department of Urology, Kulu State Hospital, Konya, Türkiye.
Participants will be evaluated in three groups according to the auditory stimulation received during the procedure: 5 Hz theta binaural beats, 10 Hz alpha binaural beats, and a control group without binaural beat stimulation. Approximately 40 patients will be included in each group.
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Exclusion Criteria:
Patients undergoing flexible cystoscopy who receive 5 Hz theta-frequency binaural beat stimulation through headphones during the procedure. Approximately 40 participants are planned for this group. Pain and anxiety levels will be evaluated using the VAS and STAI-S scales.
Patients undergoing flexible cystoscopy who receive 10 Hz alpha-frequency binaural beat stimulation through headphones during the procedure. Approximately 40 participants are planned for this group. Pain and anxiety levels will be evaluated using the VAS and STAI-S scales.
Patients undergoing flexible cystoscopy without binaural beat stimulation. Approximately 40 participants are planned for this group. The procedure will be performed according to routine clinical practice, and pain and anxiety levels will be evaluated using the VAS and STAI-S scales.
Pain Intensity During Flexible Cystoscopy Assessed by VAS
Pain experienced during flexible cystoscopy will be assessed immediately after the procedure using a Visual Analog Scale (VAS). Pain intensity will be recorded on a scale from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity. VAS scores will be compared among the 5 Hz theta binaural beat, 10 Hz alpha binaural beat, and control groups.
Time frame: During flexible cystoscopy
Change in STAI-S Score From Baseline
The change in state anxiety will be calculated as the postprocedural STAI-S score minus the preprocedural STAI-S score. Negative values indicate a reduction in anxiety. Changes will be compared among the three study groups.
Time frame: From immediately before to immediately after flexible cystoscopy.
Patient-Reported Comfort and Satisfaction
Patient-reported comfort and satisfaction with the flexible cystoscopy procedure will be assessed immediately after the procedure using the study-specific patient evaluation form. Responses will be compared among the three groups.
Time frame: During flexible cystoscopy.
Plan to share: Undecided
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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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