Benign Prostate Hypertrophy(BPH)NCT07778355
Orientation Video Training Administered at Different Times to Patients Undergoing Prostate Surgery on Postoperative Pain and Anxiety (Video Training)
A study testing Operating Room Orientation Video Education and Routine Preoperative Information in people with Benign Prostate Hypertrophy(BPH), run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of operating room orientation video education delivered at different time points on postoperative pain and state anxiety in patients undergoing surgery for benign prostatic hyperplasia. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH)
- What is being tested?
- Operating Room Orientation Video Education and Routine Preoperative Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being conscious and able to communicate. Being able to read and understand Turkish. Voluntarily agreeing to participate in the study and providing informed consent.
- Having no visual or hearing impairment that would interfere with viewing the educational video or completing the study assessments.
- Undergoing prostate surgery for the first time. Being 18 years of age or older.
Who cannot join
- Having a diagnosed psychiatric disorder. Having a chronic pain syndrome. Being scheduled for emergency surgery. Having previously received similar operating room orientation education.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ondokuz Mayıs University Health Practice and Research Center
Samsun, Atakum, 55500
Beyza Çakır, +905372600955, beyzacakir7856@gmail.com
Beyza Çakır
About this study
Official title: The Effect of Operating Room Orientation Video Education Applied at Different Times on Postoperative Pain and Anxiety in Patients Undergoing Prostate Surgery
This study aims to evaluate the effect of operating room orientation video education delivered at different time points on postoperative pain and state anxiety in patients undergoing surgery for benign prostatic hyperplasia. Patients undergoing transurethral resection of the prostate or holmium laser enucleation of the prostate will be randomly assigned to one of three groups: video education one day before surgery in the surgical ward, video education approximately 30 minutes before surgery in the operating room waiting unit, or routine preoperative information. Pain and state anxiety will be assessed at predefined preoperative and postoperative time points.
Read the detailed description
The study will evaluate whether the timing of operating room orientation video education influences postoperative pain and state anxiety in patients undergoing surgery for benign prostatic hyperplasia. The intervention consists of a 5-minute video designed to familiarize patients with the perioperative environment and expected procedures. The video includes information about the operating room environment, the operating table, patient positioning, information related to the surgical process, the post-anesthesia care unit, and patient transfer.
Participants will be randomly allocated in a 1:1:1 ratio to one of three parallel groups. Participants in the first intervention group will receive the video approximately one day before surgery in the surgical ward. Participants in the second intervention group will receive the same video approximately 30 minutes before surgery in the operating room waiting unit. Participants in the control group will receive routine preoperative information according to standard clinical practice.
Pain intensity will be assessed using the Visual Analog Scale, and state anxiety will be assessed using the State-Trait Anxiety Inventory-State Anxiety Scale. Assessments will be performed one day before surgery, before the intervention in the operating room waiting unit, and six hours after surgery in the surgical ward.
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Being tested
- Operating Room Orientation Video Education, Routine Preoperative Information
- Keywords
- Benign prostatic hyperplasia, TUR-P, HoLEP, operating room orientation, video education, postoperative pain, anxiety, patient education
- Medical subject headings
- Prostatic Hyperplasia, Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operating Room Orientation Video EducationBehavioural
A 5-minute video-based educational intervention designed to familiarize patients with the operating room environment and the perioperative process. The video includes information about the operating room environment, operating table, patient positioning, information related to the surgical process, the post-anesthesia care unit, and patient transfer.
Routine Preoperative InformationBehavioural
Participants will receive routine preoperative information according to standard clinical practice without the study-specific operating room orientation video.
| Study group | Role | What they receive |
|---|---|---|
| Ward Video Education Group | Experimental | Participants will receive a 5-minute operating room orientation video approximately one day before surgery in the surgical ward. Receives: Behavioral: Operating Room Orientation Video Education |
| Operating Room Waiting Unit Video Education Group | Experimental | Participants will receive the same 5-minute operating room orientation video approximately 30 minutes before surgery in the operating room waiting unit. Receives: Behavioral: Operating Room Orientation Video Education |
| Routine Information Control Group | Active comparator | Participants will receive routine preoperative information according to standard clinical practice without the study-specific operating room orientation video. Receives: Behavioral: Routine Preoperative Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative state anxiety
State anxiety will be assessed using the State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S), based on the Turkish adaptation by Necla Öner and Ayhan Le Compte. The scale consists of 20 items and yields a total score ranging from 20 to 80, with higher scores indicating greater state anxiety and therefore a worse outcome. State anxiety will be assessed one day before surgery in the surgical ward, before video education in the operating room waiting unit, and 6 hours after surgery in the surgical ward. The primary postoperative outcome will be the State-Trait Anxiety Inventory-State Anxiety Scale score measured 6 hours after surgery.
Measured: From baseline to 6 hours after surgery
Postoperative pain intensity
Pain intensity will be assessed using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome. Pain intensity will be assessed one day before surgery in the surgical ward, before video education in the operating room waiting unit, and 6 hours after surgery in the surgical ward. The primary postoperative outcome will be the Visual Analog Scale score measured 6 hours after surgery.
Measured: From baseline to 6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to one of three parallel groups in a 1:1:1 allocation ratio using block randomization with a block size of three.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Çakır, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778355
- Sponsor's protocol ID
- 2025/1127
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared to protect participant confidentiality and privacy. Aggregated study results will be reported in the master's thesis and subsequent scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Operating Room Orientation Video Education Applied at Different Times on Postoperative Pain and Anxiety in Patients Undergoing Prostate Surgery
- ClinicalTrials.gov ID
- NCT07778355
- Acronym / sponsor ID
- 2025/1127
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Keywords
- Benign prostatic hyperplasia, TUR-P, HoLEP, operating room orientation, video education, postoperative pain, anxiety, patient education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 21 Aug 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 study aims to evaluate the effect of operating room orientation video education delivered at different time points on postoperative pain and state anxiety in patients undergoing surgery for benign prostatic hyperplasia. Patients undergoing transurethral resection of the prostate or holmium laser enucleation of the prostate will be randomly assigned to one of three groups: video education one day before surgery in the surgical ward, video education approximately 30 minutes before surgery in the operating room waiting unit, or routine preoperative information. Pain and state anxiety will be assessed at predefined preoperative and postoperative time points.
Detailed description
The study will evaluate whether the timing of operating room orientation video education influences postoperative pain and state anxiety in patients undergoing surgery for benign prostatic hyperplasia. The intervention consists of a 5-minute video designed to familiarize patients with the perioperative environment and expected procedures. The video includes information about the operating room environment, the operating table, patient positioning, information related to the surgical process, the post-anesthesia care unit, and patient transfer.
Participants will be randomly allocated in a 1:1:1 ratio to one of three parallel groups. Participants in the first intervention group will receive the video approximately one day before surgery in the surgical ward. Participants in the second intervention group will receive the same video approximately 30 minutes before surgery in the operating room waiting unit. Participants in the control group will receive routine preoperative information according to standard clinical practice.
Pain intensity will be assessed using the Visual Analog Scale, and state anxiety will be assessed using the State-Trait Anxiety Inventory-State Anxiety Scale. Assessments will be performed one day before surgery, before the intervention in the operating room waiting unit, and six hours after surgery in the surgical ward.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly allocated to one of three parallel groups in a 1:1:1 allocation ratio using block randomization with a block size of three.
| Arm | Type | Receives |
|---|---|---|
| Ward Video Education Group | Experimental | Behavioral: Operating Room Orientation Video EducationParticipants will receive a 5-minute operating room orientation video approximately one day before surgery in the surgical ward. |
| Operating Room Waiting Unit Video Education Group | Experimental | Behavioral: Operating Room Orientation Video EducationParticipants will receive the same 5-minute operating room orientation video approximately 30 minutes before surgery in the operating room waiting unit. |
| Routine Information Control Group | Active comparator | Behavioral: Routine Preoperative InformationParticipants will receive routine preoperative information according to standard clinical practice without the study-specific operating room orientation video. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being conscious and able to communicate. Being able to read and understand Turkish. Voluntarily agreeing to participate in the study and providing informed consent.
- Having no visual or hearing impairment that would interfere with viewing the educational video or completing the study assessments.
- Undergoing prostate surgery for the first time. Being 18 years of age or older.
Key exclusion criteria (1 listed)
- Having a diagnosed psychiatric disorder. Having a chronic pain syndrome. Being scheduled for emergency surgery. Having previously received similar operating room orientation education.
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 |
|---|---|---|
| Operating Room Orientation Video EducationA 5-minute video-based educational intervention designed to familiarize patients with the operating room environment and the perioperative process. The video includes information about the operating room environment, operating table, patient positioning, information related to the surgical process, the post-anesthesia care unit, and patient transfer. | Behavioural | Operating Room Waiting Unit Video Education Group, Ward Video Education Group |
| Routine Preoperative InformationParticipants will receive routine preoperative information according to standard clinical practice without the study-specific operating room orientation video. | Behavioural | Routine Information Control Group |
Primary outcome
Postoperative state anxiety
Time frame: From baseline to 6 hours after surgery
State anxiety will be assessed using the State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S), based on the Turkish adaptation by Necla Öner and Ayhan Le Compte. The scale consists of 20 items and yields a total score ranging from 20 to 80, with higher scores indicating greater state anxiety and therefore a worse outcome. State anxiety will be assessed one day before surgery in the surgical ward, before video education in the operating room waiting unit, and 6 hours after surgery in the surgical ward. The primary postoperative outcome will be the State-Trait Anxiety Inventory-State Anxiety Scale score measured 6 hours after surgery.
Postoperative pain intensity
Time frame: From baseline to 6 hours after surgery
Pain intensity will be assessed using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome. Pain intensity will be assessed one day before surgery in the surgical ward, before video education in the operating room waiting unit, and 6 hours after surgery in the surgical ward. The primary postoperative outcome will be the Visual Analog Scale score measured 6 hours after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared to protect participant confidentiality and privacy. Aggregated study results will be reported in the master's thesis and subsequent scientific publications.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operating Room Orientation Video Education and Routine Preoperative Information in people with Benign Prostate Hypertrophy(BPH), run by Ondokuz Mayıs University 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 1 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: opening soon, as of the sponsor's last update on 16 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beyza Çakır (+905372600955, beyzacakir7856@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative state anxiety (time frame: From baseline to 6 hours after surgery). 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?
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 16 Oct 2026.