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Completed
NCT07878182
Effects of Binaural Beats on Pain and Anxiety During Flexible Cystoscopy
Conditions: Procedural Pain, Anxiety, Pain During Cystoscopy
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Enrollment: 120
Sponsor: Saglik Bilimleri Universitesi
Location: Kulu State Hospital Konya Kulu
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 to 80 years.
* Patients scheduled to undergo flexible cystoscopy for diagnostic or follow-up purposes.
* Ability to provide written informed consent.
* Ability to complete pain and anxiety assessment scales.
* Adequate hearing ability to perceive auditory stimulation.
Exclusion Criteria:
* Active urinary tract infection.
* Hearing loss or a history of severe tinnitus.
* History of epilepsy.
* Use of sedative, anxiolytic, or analgesic medications within the previous 24 hours.
* History of significant psychiatric disorders.
* Severe cognitive impairment.
* Inability to complete the flexible cystoscopy procedure.
Source: ClinicalTrials.gov (NCT07878182). StuddyBuddy aggregates publicly available trial information.