AnxietyVIDEOCYSNCT07101211
Video Education to Reduce Anxiety and Depression Before Cystoscopy: A Study in First-Time Patients
A study testing Video-Based Educational Animation and Standard Written Informed Consent in people with Anxiety and Depression Anxiety Disorder, run by Enis Mert Yorulmaz at 1 site in Turkey (Türkiye).
Trial summary
This study looks at whether watching a short educational video before a cystoscopy can help reduce feelings of anxiety, stress, and depression in patients having the procedure for the first time. Cystoscopy is a test that helps doctors see inside the bladder and urinary tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression Anxiety Disorder, Stress, Psychological
- What is being tested?
- Video-Based Educational Animation and Standard Written Informed Consent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 14 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Undergoing first-time cystoscopy
- Provided written informed consent
Who cannot join
- History of previous cystoscopy
- Active urinary tract infection
- Cognitive impairment
- Current use of psychotropic medications
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Celebi University Ataturk Training and Research Hospital
Izmir, 35360
About this study
Official title: Effect of Video-Based Information on Anxiety, Depression, and Stress Before Cystoscopy: A Prospective Randomized Controlled Tria
This study looks at whether watching a short educational video before a cystoscopy can help reduce feelings of anxiety, stress, and depression in patients having the procedure for the first time. Cystoscopy is a test that helps doctors see inside the bladder and urinary tract. It can cause worry or fear, especially for patients who have never had it before. In this study, 180 adult patients were divided into two groups. One group received standard written information about the procedure, and the other group received the same written information plus a short, easy-to-understand animation video that explains what will happen during cystoscopy. The video shows what patients might feel, what the procedure looks like, and what to expect afterward. The study measured how patients felt before and after the procedure to see if the video helped them feel calmer and more prepared. The goal is to find out if using videos before medical procedures can improve the patient experience and reduce stress and anxiety.
Read the detailed description
This prospective, randomized, controlled clinical trial was designed to evaluate the impact of video-based educational interventions on reducing anxiety, depression, and stress levels in patients undergoing cystoscopy for the first time. Cystoscopy is a diagnostic and therapeutic procedure used to examine the bladder and lower urinary tract and may cause significant anxiety and emotional distress, particularly among patients undergoing the procedure for the first time due to its invasive nature and unfamiliarity. This study was conducted at the Urology Clinic of Izmir Katip Celebi University Ataturk Training and Research Hospital, and included 180 adult patients scheduled for their first cystoscopy between May 15 and June 14, 2025.
Participants were randomized using an odd-even allocation method into two groups: (1) the Video Education Group, which received the standard written informed consent document along with a Turkish-dubbed educational animation video explaining the cystoscopy procedure in a clear and patient-friendly manner, and (2) the Control Group, which received only the standard written informed consent document without the video intervention. The educational animation video used in the study was developed by the European Association of Urology (EAU) and adapted with Turkish narration to improve patient comprehension. The video, approximately three minutes in duration, covered the anatomy of the lower urinary tract, the steps of the cystoscopy procedure, the sensations patients may experience during the procedure, and post-procedure expectations such as transient hematuria and mild discomfort. Patients in the video group watched the animation via their personal mobile devices using a QR code approximately 15-20 minutes prior to the procedure while waiting for cystoscopy.
The primary aim of the study was to determine whether the video-based educational intervention could reduce the short-term psychological distress associated with cystoscopy, with a focus on anxiety reduction as the primary outcome. Secondary aims included evaluating the effects of the intervention on stress and depressive symptoms measured using validated psychological assessment tools. These included the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) and Depression Subscale (HADS-D), the State-Trait Anxiety Inventory - State Form (STAI TX-I), and the Beck Depression Inventory (BDI), all of which have validated Turkish versions used to ensure consistency and accuracy in the patient population. Pain perception following the procedure was assessed using the Visual Analog Scale (VAS) as an additional secondary outcome. All measurements were taken immediately before the cystoscopy and within 30 minutes after the procedure to capture the acute psychological response to the intervention and the procedure itself.
Patients were included if they were over 18 years of age, scheduled for their first cystoscopy, and provided written informed consent. Exclusion criteria included a history of previous cystoscopy, active urinary tract infections, cognitive impairment, and the use of psychotropic medications, which could confound the psychological assessments. The cystoscopy procedure was performed using a 22Fr rigid cystoscope with a 30-degree optic, following the administration of 10 mL of 2% lidocaine gel intraurethrally for local anesthesia, ensuring standardization across all procedures. All procedures were conducted by the same experienced urology team in a controlled outpatient clinic environment to maintain procedural consistency and reduce operator-related variability.
Statistical analyses were conducted using Jamovi (version 2.6) and R (version 4.4.0). The normality of continuous data was evaluated using the Shapiro-Wilk test. Depending on the distribution, independent samples t-tests or Mann-Whitney U tests were used to compare differences between groups. A 2x2 repeated measures ANOVA was performed to analyze the effects of time (pre- and post-procedure), group (video vs. control), and the interaction between time and group on psychological outcomes. Subgroup analyses based on patients' education and employment status were conducted using multivariate repeated measures ANOVA with Bonferroni-adjusted post-hoc tests to assess the potential moderating effects of these variables on the intervention's effectiveness. Effect sizes were reported using partial eta squared (η²p) to indicate the magnitude of the observed effects.
A priori power analysis was conducted using G*Power version 3.1, with a medium effect size (Cohen's d = 0.50), an alpha level of 0.05, and a desired power of 0.90, indicating a minimum required sample size of 86 participants per group, which was met by the final enrollment of 180 patients, ensuring the study was sufficiently powered to detect statistically significant differences.
The study adhered to ethical principles in accordance with the Declaration of Helsinki and was approved by the Izmir Katip Celebi University Health Research Ethics Committee (IRB#0242, Date: May 15, 2025). Written informed consent was obtained from all participants prior to enrollment in the study. No external funding influenced the study design, data collection, analysis, or reporting, ensuring the objectivity and independence of the research findings.
- Being tested
- Video-Based Educational Animation, Standard Written Informed Consent
- Keywords
- Video-based education, Cystoscopy, Anxiety, Psychological stress, Depression
- Medical subject headings
- Anxiety Disorders, Stress, Psychological, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Based Educational AnimationBehavioural
A short, Turkish-dubbed educational animation video explaining the cystoscopy procedure, including steps of the procedure, expected sensations, and post-procedure care. The video is viewed by patients via QR code on their mobile devices before the cystoscopy to enhance patient understanding and reduce anxiety, stress, and depression.
Standard Written Informed ConsentOther
A standard written informed consent form describing the cystoscopy procedure, including the purpose, steps, possible sensations, and post-procedure care, provided to all participants before the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Video-Based Education + Standard Written Information | Experimental | Participants in this arm received the standard written informed consent form for cystoscopy along with a Turkish-dubbed educational animation video explaining the cystoscopy procedure. The video was provided via a QR code to allow patients to watch it on their mobile devices while waiting for the procedure. The video covered the procedure steps, sensations to expect, and post-procedure care. Receives: Behavioral: Video-Based Educational Animation; Other: Standard Written Informed Consent |
| Standard Written Information Only | Active comparator | Participants in this arm received only the standard written informed consent form describing the cystoscopy procedure. No video-based educational intervention was provided before the procedure. Receives: Other: Standard Written Informed Consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Levels Assessed by HADS-A Before and After Cystoscopy
The Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) assesses anxiety symptoms in patients while minimizing the influence of physical illness.
It includes 7 items scored from 0 to 3, with a total score range of 0-21. Scores are interpreted as: 0-7 normal, 8-10 borderline, 11-21 abnormal.
It avoids somatic symptoms and is widely validated across medical settings. The Turkish version used in this study was validated by Aydemir (1997).
Due to its brevity and focus on emotional symptoms, HADS-A is suitable for measuring procedural anxiety before and after interventions such as cystoscopy.
Turkish Validation: Aydemir O. Validity and Reliability of Turkish Version of Hospital Anxiety and Depression Scale. Turkish Journal of Psychiatry. 1997 Apr;8:280-7.
Measured: Immediately before cystoscopy and within 30 minutes post-procedure
Change in Anxiety Levels Assessed by STAI Form TX-I Before and After Cystoscopy
The State-Trait Anxiety Inventory - State Form (STAI Form TX-I) is a 20-item self-report scale measuring temporary, situation-specific anxiety.
Each item is rated on a 4-point Likert scale, with scores ranging from 20 to 80. Higher scores indicate more severe state anxiety. Some items are reverse scored.
Typical interpretations: 20-37 (low), 38-44 (moderate), ≥45 (high anxiety).
The Turkish version was validated by Öner \& LeCompte (1983). It is widely used in procedural settings to assess acute stress responses and emotional tension before and after interventions such as cystoscopy.
Turkish Validation: Öner, Necla, William Ayhan LeCompte. Durumluk Surekli Kaygi Envanteri El Kitabi, Bogazici Universitesi Yayinlari, Istanbul, 1-26. (In Turkish). 1983.
Measured: Immediately before cystoscopy and within 30 minutes post-procedure
Secondary outcomes (2)
Change in Depression Levels Assessed by HADS-D Before and After Cystoscopy
The Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D) is a 7-item scale assessing depressive symptoms in medical patients, minimizing confounding from somatic complaints.
Each item is scored 0-3, for a total score between 0 and 21. Higher scores indicate more severe depression: 0-7 normal, 8-10 borderline, 11-21 abnormal. The scale excludes physical symptoms like fatigue or appetite loss, making it ideal for use in hospital and outpatient settings.
The Turkish version used in this study was validated by Aydemir (1997) and is widely applied in clinical research.
Turkish Validation: Aydemir O. Validity and Reliability of Turkish Version of Hospital Anxiety and Depression Scale. Turkish Journal of Psychiatry. 1997 Apr;8:280-7.
Measured: Immediately before cystoscopy and within 30 minutes post-procedure
Change in Depression Levels Assessed by Beck Depression Inventory (BDI) Before and After Cystoscopy
The Beck Depression Inventory (BDI) is a 21-item self-report scale assessing emotional, cognitive, and somatic symptoms of depression.
Each item includes four response options scored from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate more severe depression: 0-13 minimal, 14-19 mild, 20-28 moderate, ≥29 severe.
The Turkish version used in this study was validated by Tekindal et al. (2021).
BDI is widely used in clinical research to measure depressive symptom severity and to assess changes in mood before and after medical interventions.
Turkish Validation: Tekindal M, Tekindal MA. Validity and Reliability of Basic Depression Scale For Turkey. Batı Karadeniz Tıp Dergisi. 2021 Dec 25;5(3):452-63.
Measured: Immediately before cystoscopy and within 30 minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start15 May 2025
- Primary completion14 Jun 2025
- Study completion14 Jun 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 AnxietyStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a parallel design to one of two groups: a control group receiving standard written information about cystoscopy, and an intervention group receiving the same written information plus an educational animation video prior to the procedure. Outcomes were assessed pre- and post-procedure in both groups to compare the effects of video-based education on anxiety, stress, and depression levels.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enis Mert Yorulmaz
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Katip Celebi University
- Responsible party
- Sponsor-investigator, Enis Mert Yorulmaz, Izmir Katip Celebi University
- Investigators
- Enis M Yorulmaz, Assist Prof, Principal investigator, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101211
- Sponsor's protocol ID
- IRB0242IKCU
- Acronym
- VIDEOCYS
- Status last verified
- Jul 2025
- First submitted
- 29 Jun 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data (IPD) from this study. However, IPD may be considered for sharing upon reasonable request from journal editors or qualified researchers, in compliance with institutional policies and data protection regulations.
Publications
McClintock G, Wong E, Mancuso P, Lalak N, Gassner P, Haghighi K, Rathore P, McAulay L, Jeffery N. Music during flexible cystoscopy for pain and anxiety - a patient-blinded randomised control trial. BJU Int. 2021 Oct;128 Suppl 1:27-32. doi: 10.1111/bju.15527. Epub 2021 Jul 30.
PubMed 34174137Zhang ZS, Wang XL, Xu CL, Zhang C, Cao Z, Xu WD, Wei RC, Sun YH. Music reduces panic: an initial study of listening to preferred music improves male patient discomfort and anxiety during flexible cystoscopy. J Endourol. 2014 Jun;28(6):739-44. doi: 10.1089/end.2013.0705. Epub 2014 Mar 31.
PubMed 24548148Gauba A, Ramachandra MN, Saraogi M, Geraghty R, Hameed BMZ, Abumarzouk O, Somani BK. Music reduces patient-reported pain and anxiety and should be routinely offered during flexible cystoscopy: Outcomes of a systematic review. Arab J Urol. 2021 Mar 3;19(4):480-487. doi: 10.1080/2090598X.2021.1894814. eCollection 2021.
PubMed 34881066Kwon OS, Kwon B, Kim J, Kim BH. Effects of Heating Therapy on Pain, Anxiety, Physiologic Measures, and Satisfaction in Patients Undergoing Cystoscopy. Asian Nurs Res (Korean Soc Nurs Sci). 2022 May;16(2):73-79. doi: 10.1016/j.anr.2022.02.002. Epub 2022 Feb 20.
PubMed 35196580
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Video-Based Information on Anxiety, Depression, and Stress Before Cystoscopy: A Prospective Randomized Controlled Tria
- ClinicalTrials.gov ID
- NCT07101211
- Acronym / sponsor ID
- VIDEOCYS / IRB0242IKCU
- Keywords
- Video-based education, Cystoscopy, Anxiety, Psychological stress, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Enis Mert YorulmazUniversity, hospital or other
- Collaborators
- Izmir Katip Celebi University
- Study start
- 15 May 2025 (actual)
- Primary completion
- 14 Jun 2025 (actual)
- Study completion
- 14 Jun 2025 (actual)
- First posted
- 3 Aug 2025 (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 looks at whether watching a short educational video before a cystoscopy can help reduce feelings of anxiety, stress, and depression in patients having the procedure for the first time. Cystoscopy is a test that helps doctors see inside the bladder and urinary tract. It can cause worry or fear, especially for patients who have never had it before. In this study, 180 adult patients were divided into two groups. One group received standard written information about the procedure, and the other group received the same written information plus a short, easy-to-understand animation video that explains what will happen during cystoscopy. The video shows what patients might feel, what the procedure looks like, and what to expect afterward. The study measured how patients felt before and after the procedure to see if the video helped them feel calmer and more prepared. The goal is to find out if using videos before medical procedures can improve the patient experience and reduce stress and anxiety.
Detailed description
This prospective, randomized, controlled clinical trial was designed to evaluate the impact of video-based educational interventions on reducing anxiety, depression, and stress levels in patients undergoing cystoscopy for the first time. Cystoscopy is a diagnostic and therapeutic procedure used to examine the bladder and lower urinary tract and may cause significant anxiety and emotional distress, particularly among patients undergoing the procedure for the first time due to its invasive nature and unfamiliarity. This study was conducted at the Urology Clinic of Izmir Katip Celebi University Ataturk Training and Research Hospital, and included 180 adult patients scheduled for their first cystoscopy between May 15 and June 14, 2025.
Participants were randomized using an odd-even allocation method into two groups: (1) the Video Education Group, which received the standard written informed consent document along with a Turkish-dubbed educational animation video explaining the cystoscopy procedure in a clear and patient-friendly manner, and (2) the Control Group, which received only the standard written informed consent document without the video intervention. The educational animation video used in the study was developed by the European Association of Urology (EAU) and adapted with Turkish narration to improve patient comprehension. The video, approximately three minutes in duration, covered the anatomy of the lower urinary tract, the steps of the cystoscopy procedure, the sensations patients may experience during the procedure, and post-procedure expectations such as transient hematuria and mild discomfort. Patients in the video group watched the animation via their personal mobile devices using a QR code approximately 15-20 minutes prior to the procedure while waiting for cystoscopy.
The primary aim of the study was to determine whether the video-based educational intervention could reduce the short-term psychological distress associated with cystoscopy, with a focus on anxiety reduction as the primary outcome. Secondary aims included evaluating the effects of the intervention on stress and depressive symptoms measured using validated psychological assessment tools. These included the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) and Depression Subscale (HADS-D), the State-Trait Anxiety Inventory - State Form (STAI TX-I), and the Beck Depression Inventory (BDI), all of which have validated Turkish versions used to ensure consistency and accuracy in the patient population. Pain perception following the procedure was assessed using the Visual Analog Scale (VAS) as an additional secondary outcome. All measurements were taken immediately before the cystoscopy and within 30 minutes after the procedure to capture the acute psychological response to the intervention and the procedure itself.
Patients were included if they were over 18 years of age, scheduled for their first cystoscopy, and provided written informed consent. Exclusion criteria included a history of previous cystoscopy, active urinary tract infections, cognitive impairment, and the use of psychotropic medications, which could confound the psychological assessments. The cystoscopy procedure was performed using a 22Fr rigid cystoscope with a 30-degree optic, following the administration of 10 mL of 2% lidocaine gel intraurethrally for local anesthesia, ensuring standardization across all procedures. All procedures were conducted by the same experienced urology team in a controlled outpatient clinic environment to maintain procedural consistency and reduce operator-related variability.
Statistical analyses were conducted using Jamovi (version 2.6) and R (version 4.4.0). The normality of continuous data was evaluated using the Shapiro-Wilk test. Depending on the distribution, independent samples t-tests or Mann-Whitney U tests were used to compare differences between groups. A 2x2 repeated measures ANOVA was performed to analyze the effects of time (pre- and post-procedure), group (video vs. control), and the interaction between time and group on psychological outcomes. Subgroup analyses based on patients' education and employment status were conducted using multivariate repeated measures ANOVA with Bonferroni-adjusted post-hoc tests to assess the potential moderating effects of these variables on the intervention's effectiveness. Effect sizes were reported using partial eta squared (η²p) to indicate the magnitude of the observed effects.
A priori power analysis was conducted using G*Power version 3.1, with a medium effect size (Cohen's d = 0.50), an alpha level of 0.05, and a desired power of 0.90, indicating a minimum required sample size of 86 participants per group, which was met by the final enrollment of 180 patients, ensuring the study was sufficiently powered to detect statistically significant differences.
The study adhered to ethical principles in accordance with the Declaration of Helsinki and was approved by the Izmir Katip Celebi University Health Research Ethics Committee (IRB#0242, Date: May 15, 2025). Written informed consent was obtained from all participants prior to enrollment in the study. No external funding influenced the study design, data collection, analysis, or reporting, ensuring the objectivity and independence of the research findings.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a parallel design to one of two groups: a control group receiving standard written information about cystoscopy, and an intervention group receiving the same written information plus an educational animation video prior to the procedure. Outcomes were assessed pre- and post-procedure in both groups to compare the effects of video-based education on anxiety, stress, and depression levels.
| Arm | Type | Receives |
|---|---|---|
| Video-Based Education + Standard Written Information | Experimental | Behavioral: Video-Based Educational Animation, Other: Standard Written Informed ConsentParticipants in this arm received the standard written informed consent form for cystoscopy along with a Turkish-dubbed educational animation video explaining the cystoscopy procedure. The video was provided via a QR code to allow patients to watch it on their mobile devices while waiting for the procedure. The video covered the procedure steps, sensations to expect, and post-procedure care. |
| Standard Written Information Only | Active comparator | Other: Standard Written Informed ConsentParticipants in this arm received only the standard written informed consent form describing the cystoscopy procedure. No video-based educational intervention was provided before the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Undergoing first-time cystoscopy
- Provided written informed consent
Key exclusion criteria (4 listed)
- History of previous cystoscopy
- Active urinary tract infection
- Cognitive impairment
- Current use of psychotropic medications
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 |
|---|---|---|
| Video-Based Educational AnimationA short, Turkish-dubbed educational animation video explaining the cystoscopy procedure, including steps of the procedure, expected sensations, and post-procedure care. The video is viewed by patients via QR code on their mobile devices before the cystoscopy to enhance patient understanding and reduce anxiety, stress, and depression. | Behavioural | Video-Based Education + Standard Written Information |
| Standard Written Informed ConsentA standard written informed consent form describing the cystoscopy procedure, including the purpose, steps, possible sensations, and post-procedure care, provided to all participants before the procedure. | Other | Standard Written Information Only, Video-Based Education + Standard Written Information |
Primary outcome
Change in Anxiety Levels Assessed by HADS-A Before and After Cystoscopy
Time frame: Immediately before cystoscopy and within 30 minutes post-procedure
The Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) assesses anxiety symptoms in patients while minimizing the influence of physical illness. It includes 7 items scored from 0 to 3, with a total score range of 0-21. Scores are interpreted as: 0-7 normal, 8-10 borderline, 11-21 abnormal. It avoids somatic symptoms and is widely validated across medical settings. The Turkish version used in this study was validated by Aydemir (1997). Due to its brevity and focus on emotional symptoms, HADS-A is suitable for measuring procedural anxiety before and after interventions such as cystoscopy. Turkish Validation: Aydemir O. Validity and Reliability of Turkish Version of Hospital Anxiety and Depression Scale. Turkish Journal of Psychiatry. 1997 Apr;8:280-7.
Change in Anxiety Levels Assessed by STAI Form TX-I Before and After Cystoscopy
Time frame: Immediately before cystoscopy and within 30 minutes post-procedure
The State-Trait Anxiety Inventory - State Form (STAI Form TX-I) is a 20-item self-report scale measuring temporary, situation-specific anxiety. Each item is rated on a 4-point Likert scale, with scores ranging from 20 to 80. Higher scores indicate more severe state anxiety. Some items are reverse scored. Typical interpretations: 20-37 (low), 38-44 (moderate), ≥45 (high anxiety). The Turkish version was validated by Öner \& LeCompte (1983). It is widely used in procedural settings to assess acute stress responses and emotional tension before and after interventions such as cystoscopy. Turkish Validation: Öner, Necla, William Ayhan LeCompte. Durumluk Surekli Kaygi Envanteri El Kitabi, Bogazici Universitesi Yayinlari, Istanbul, 1-26. (In Turkish). 1983.
2 secondary outcomes
Change in Depression Levels Assessed by HADS-D Before and After Cystoscopy
Time frame: Immediately before cystoscopy and within 30 minutes post-procedure
Change in Depression Levels Assessed by Beck Depression Inventory (BDI) Before and After Cystoscopy
Time frame: Immediately before cystoscopy and within 30 minutes post-procedure
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 3 Aug 2025.
- Results publication: PubMed 34174137McClintock G, Wong E, Mancuso P, Lalak N, Gassner P, Haghighi K, Rathore P, McAulay L, Jeffery N. Music during flexible cystoscopy for pain and anxiety - a patient-blinded randomised control trial. BJU Int. 2021 Oct;128 Suppl 1:27-32. doi: 10.1111/bju.15527. Epub 2021 Jul 30.
- Results publication: PubMed 24548148Zhang ZS, Wang XL, Xu CL, Zhang C, Cao Z, Xu WD, Wei RC, Sun YH. Music reduces panic: an initial study of listening to preferred music improves male patient discomfort and anxiety during flexible cystoscopy. J Endourol. 2014 Jun;28(6):739-44. doi: 10.1089/end.2013.0705. Epub 2014 Mar 31.
- Results publication: PubMed 34881066Gauba A, Ramachandra MN, Saraogi M, Geraghty R, Hameed BMZ, Abumarzouk O, Somani BK. Music reduces patient-reported pain and anxiety and should be routinely offered during flexible cystoscopy: Outcomes of a systematic review. Arab J Urol. 2021 Mar 3;19(4):480-487. doi: 10.1080/2090598X.2021.1894814. eCollection 2021.
- Results publication: PubMed 35196580Kwon OS, Kwon B, Kim J, Kim BH. Effects of Heating Therapy on Pain, Anxiety, Physiologic Measures, and Satisfaction in Patients Undergoing Cystoscopy. Asian Nurs Res (Korean Soc Nurs Sci). 2022 May;16(2):73-79. doi: 10.1016/j.anr.2022.02.002. Epub 2022 Feb 20.
- Video animation of the cystoscopy procedure (prepared by EAU). This video was shown to the patients in the intervention group with Turkish dubbing.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data (IPD) from this study. However, IPD may be considered for sharing upon reasonable request from journal editors or qualified researchers, in compliance with institutional policies and data protection regulations.
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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.
Enis M Yorulmaz, Assist Prof principal investigator
Izmir Katip Celebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Based Educational Animation and Standard Written Informed Consent in people with Anxiety and Depression Anxiety Disorder, run by Enis Mert Yorulmaz 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 3 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 3 Aug 2025. 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?
Change in Anxiety Levels Assessed by HADS-A Before and After Cystoscopy (time frame: Immediately before cystoscopy and within 30 minutes post-procedure). The study lists 2 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 NCT07101211, 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 3 Aug 2025.