Procedural PainNCT07878182
Effects of Binaural Beats on Pain and Anxiety During Flexible Cystoscopy
An observational study of Procedural Pain and Anxiety, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Procedural Pain, Anxiety, Pain During Cystoscopy
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Oct 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Binaural Beat Stimulation on Pain and Anxiety During Flexible Cystoscopy: A Prospective Three-Group Comparative Study
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Procedural Pain, Anxiety, Pain During Cystoscopy
- Keywords
- Flexible Cystoscopy, Binaural Beats, Theta Frequency, Alpha Frequency, Patient Comfort
- Medical subject headings
- Pain, Procedural, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Theta Binaural Beat (5 Hz) | 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. | |
| Group 2 - Alpha Binaural Beat (10 Hz) | 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. | |
| Group 3 - Control Group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During flexible cystoscopy
Secondary outcomes (2)
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.
Measured: 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.
Measured: During flexible cystoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jun 2026
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÇAĞRI ÖKTEM, Ministry of Health, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878182
- Sponsor's protocol ID
- AESH-EK-2026-085
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Binaural Beat Stimulation on Pain and Anxiety During Flexible Cystoscopy: A Prospective Three-Group Comparative Study
- ClinicalTrials.gov ID
- NCT07878182
- Acronym / sponsor ID
- AESH-EK-2026-085
- Conditions
- Procedural Pain, Anxiety, Pain During Cystoscopy
- Keywords
- Flexible Cystoscopy, Binaural Beats, Theta Frequency, Alpha Frequency, Patient Comfort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 16 Oct 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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Theta Binaural Beat (5 Hz) | – | –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. |
| Group 2 - Alpha Binaural Beat (10 Hz) | – | –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. |
| Group 3 - Control Group | – | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Intensity During Flexible Cystoscopy Assessed by VAS
Time frame: During flexible cystoscopy
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.
2 secondary outcomes
Change in STAI-S Score From Baseline
Time frame: From immediately before to immediately after flexible cystoscopy.
Patient-Reported Comfort and Satisfaction
Time frame: During flexible 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 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Procedural Pain and Anxiety, run by Saglik Bilimleri Universitesi 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 5 inclusion and 7 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 19 Oct 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?
Pain Intensity During Flexible Cystoscopy Assessed by VAS (time frame: During flexible cystoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.