Bladder Tumor (TURBT)NCT07203989
The Effect of Video Calls With Family Members During Operating Room Waiting on Stress, Anxiety, and Surgical Fear in Patients Undergoing Transurethral Resection of Bladder Tumor
A study testing family-supported care in people with Bladder Tumor (TURBT) and Bladder (Urothelial, Transitional Cell) Cancer, run by Bitlis Eren University at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to investigate the effect of video calls with family members during the preoperative waiting period in the operating room on stress, anxiety, and surgical fear in patients undergoing transurethral resection of bladder tumor (TURBT). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bladder Tumor (TURBT), Bladder (Urothelial, Transitional Cell) Cancer
- What is being tested?
- family-supported care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 15 Sep 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Able to read and write in Turkish
- Scheduled for transurethral resection of bladder tumor (TURBT)
- Has a family member, friend, or relative able to participate in video calls
- The accompanying family member or relative has a device suitable for video calls (smartphone, tablet, etc.)
- Has waited at least 20 minutes in the operating room before surgery
Show all 11Show fewer
- No hearing, speech, or language-related communication barriers
- No psychological disorders that could affect fear or anxiety
- Not using medications that could alter fear or anxiety levels
- Scheduled for surgery between 08:00 and 12:00
- Willing to voluntarily participate in the study
Who cannot join
- Surgery is canceled after the patient has been enrolled in the study
- Patient chooses to withdraw from the study after enrollment
- Individuals with any diagnosed chronic disease
- Experiencing connection problems during the video call
- Patients who receive premedication during the waiting period to relieve anxiety
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Tatvan State Hospital, Bitlis, Turkey
Bitlis, Tatvan
Bitlis State Hospital, Bitlis, Turkey
Bitlis
About this study
Official title: The Effect of Video Calls With Family Members During Operating Room Waiting on Stress, Anxiety, and Surgical Fear in Patients Undergoing Transurethral Resection of Bladder Tumor: A Multicenter Randomized Controlled Trial
This study aims to investigate the effect of video calls with family members during the preoperative waiting period in the operating room on stress, anxiety, and surgical fear in patients undergoing transurethral resection of bladder tumor (TURBT). Bladder cancer is a common urological malignancy, and psychological problems are frequently observed in the preoperative period. The absence of family support in the operating room may increase anxiety and fear, triggering physiological stress responses and raising the risk of complications.
This multicenter randomized controlled trial will be conducted between September 2025 and March 2027 at Bitlis State Hospital and Tatvan State Hospital. The study sample will include 128 eligible patients, randomly assigned to intervention and control groups. Patients in the intervention group will have a video call with a designated family member in the operating room, while control group patients will receive routine care.
Read more
Data will be collected using the Descriptive Information Form, the Surgical Fear Questionnaire, and the Visual Analogue Scale; stress levels will be assessed through serum cortisol and glucose values. Measurements will be taken at three time points: preoperatively (T0), immediately before anesthesia (T1), and on the first postoperative day (T2).
The study is expected to demonstrate that maintaining family support through video calls in the preoperative period reduces anxiety, fear, and stress, thereby improving surgical outcomes and contributing to the development of family-centered care practices.
Read the detailed description
This study investigates the effect of family-supported video calls on patients with bladder tumor scheduled for transurethral resection (TURBT) during the preoperative waiting period in the operating room. Preoperative anxiety, surgical fear, and stress are common among surgical patients and may negatively influence physiological responses and postoperative outcomes. Allowing real-time communication with a family member through a secure digital platform may provide psychological support, reduce anxiety and fear, and mitigate stress-related physiological changes.
The study is designed as a multicenter randomized controlled trial conducted at Bitlis State Hospital and Tatvan State Hospital between September 2025 and March 2027. Eligible patients will be randomly assigned to either the intervention group, who will have a structured video call with a designated family member before anesthesia induction, or the control group, who will receive standard preoperative care without family contact in the operating room. Outcomes will include anxiety, surgical fear, and stress levels, measured using validated scales and physiological parameters. Findings from this study are expected to contribute to the development of family-centered care strategies aimed at improving perioperative psychological well-being and surgical outcomes.
- Being tested
- family-supported care
- Keywords
- Transurethral resection of bladder tumor (TURBT), Preoperative anxiety, Surgical fear, Family-centered care, Video call intervention
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family-supported careBehavioural
Also called Family video calling in the operating room
Family video calling in the operating room
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Intervention Group | Experimental | Family Meeting:Patients will have a real-time video call with one designated family member while waiting in the operating room before anesthesia induction. The call will last until anesthesia preparation begins. Receives: Behavioral: family-supported care |
| Control Group | No intervention | Standard Maintenance: Patients will undergo the standard surgical preparation and waiting process in the operating room without any contact with family members. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Level (Visual Analogue Scale)
Anxiety levels will be assessed using the Visual Analogue Scale (VAS), scored from 0 (no anxiety) to 10 (worst possible anxiety). Higher scores indicate greater anxiety.
Measured: Anxiety levels will be measured at three different time points: T0: On the morning of the surgery, at 08:00 in the ward T1: In the operating room, immediately before anesthesia induction T2: The morning after the surgery, at 08:00
stress
Serum cortisol and serum glucose levels will be measured to determine patients' stress levels. Increases in cortisol and glucose levels indicate increased stress levels.
Measured: Blood samples will be collected from patients at three different times. • T0: On the morning of surgery, in the ward at 8:00 a.m. • T1: In the operating room, just before anesthesia induction • T2: The day after surgery, at 8:00 a.m.
Surgical Fear Level
The Surgical Fear Scale (SFS) will be used to determine the level of fear in patients.
Surgical Fear Scale: The Surgical Fear Scale was first developed by Theunissen et al. in 2014 to determine the level of surgical fear in patients undergoing surgery.
The Surgical Fear Scale consists of eight items and two subscales, scored from 0 to 10. The first four items measure fear of short-term surgical outcomes, and the last four items measure fear of long-term outcomes. Each subscale is aggregated, and the sum of the two subscale scores constitutes the total scale score. The total score for the scale ranges from 0 to 80. Low scores indicate low levels of surgical fear, while high scores indicate high levels of surgical fear.
Measured: Patients' surgical fear levels will be measured at two different times. • T0: On the morning of surgery, in the ward at 8:00 a.m. • T1: In the operating room, just before anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Tumor (TURBT)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdogan Yakit, Bitlis Eren University
- Investigators
- Erdoğan YAKIT, Study chair, BİTLİS EREN UNİVERSTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203989
- Sponsor's protocol ID
- HKU-2025-TURBT-FV-RCT01
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared due to patient confidentiality and privacy concerns, as well as institutional regulations regarding clinical data handling.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video Calls With Family Members During Operating Room Waiting on Stress, Anxiety, and Surgical Fear in Patients Undergoing Transurethral Resection of Bladder Tumor: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07203989
- Acronym / sponsor ID
- HKU-2025-TURBT-FV-RCT01
- Keywords
- Transurethral resection of bladder tumor (TURBT), Preoperative anxiety, Surgical fear, Family-centered care, Video call intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 2 Oct 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 aims to investigate the effect of video calls with family members during the preoperative waiting period in the operating room on stress, anxiety, and surgical fear in patients undergoing transurethral resection of bladder tumor (TURBT). Bladder cancer is a common urological malignancy, and psychological problems are frequently observed in the preoperative period. The absence of family support in the operating room may increase anxiety and fear, triggering physiological stress responses and raising the risk of complications.
This multicenter randomized controlled trial will be conducted between September 2025 and March 2027 at Bitlis State Hospital and Tatvan State Hospital. The study sample will include 128 eligible patients, randomly assigned to intervention and control groups. Patients in the intervention group will have a video call with a designated family member in the operating room, while control group patients will receive routine care.
Data will be collected using the Descriptive Information Form, the Surgical Fear Questionnaire, and the Visual Analogue Scale; stress levels will be assessed through serum cortisol and glucose values. Measurements will be taken at three time points: preoperatively (T0), immediately before anesthesia (T1), and on the first postoperative day (T2).
The study is expected to demonstrate that maintaining family support through video calls in the preoperative period reduces anxiety, fear, and stress, thereby improving surgical outcomes and contributing to the development of family-centered care practices.
Detailed description
This study investigates the effect of family-supported video calls on patients with bladder tumor scheduled for transurethral resection (TURBT) during the preoperative waiting period in the operating room. Preoperative anxiety, surgical fear, and stress are common among surgical patients and may negatively influence physiological responses and postoperative outcomes. Allowing real-time communication with a family member through a secure digital platform may provide psychological support, reduce anxiety and fear, and mitigate stress-related physiological changes.
The study is designed as a multicenter randomized controlled trial conducted at Bitlis State Hospital and Tatvan State Hospital between September 2025 and March 2027. Eligible patients will be randomly assigned to either the intervention group, who will have a structured video call with a designated family member before anesthesia induction, or the control group, who will receive standard preoperative care without family contact in the operating room. Outcomes will include anxiety, surgical fear, and stress levels, measured using validated scales and physiological parameters. Findings from this study are expected to contribute to the development of family-centered care strategies aimed at improving perioperative psychological well-being and surgical outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - Intervention Group | Experimental | Behavioral: family-supported careFamily Meeting:Patients will have a real-time video call with one designated family member while waiting in the operating room before anesthesia induction. The call will last until anesthesia preparation begins. |
| Control Group | No intervention | –Standard Maintenance: Patients will undergo the standard surgical preparation and waiting process in the operating room without any contact with family members. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years or older
- Able to read and write in Turkish
- Scheduled for transurethral resection of bladder tumor (TURBT)
- Has a family member, friend, or relative able to participate in video calls
- The accompanying family member or relative has a device suitable for video calls (smartphone, tablet, etc.)
Key exclusion criteria (5 listed)
- Surgery is canceled after the patient has been enrolled in the study
- Patient chooses to withdraw from the study after enrollment
- Individuals with any diagnosed chronic disease
- Experiencing connection problems during the video call
- Patients who receive premedication during the waiting period to relieve anxiety
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 |
|---|---|---|
| family-supported careAlso: Family video calling in the operating roomFamily video calling in the operating room | Behavioural | Experimental - Intervention Group |
Primary outcome
Change in Anxiety Level (Visual Analogue Scale)
Time frame: Anxiety levels will be measured at three different time points: T0: On the morning of the surgery, at 08:00 in the ward T1: In the operating room, immediately before anesthesia induction T2: The morning after the surgery, at 08:00
Anxiety levels will be assessed using the Visual Analogue Scale (VAS), scored from 0 (no anxiety) to 10 (worst possible anxiety). Higher scores indicate greater anxiety.
stress
Time frame: Blood samples will be collected from patients at three different times. • T0: On the morning of surgery, in the ward at 8:00 a.m. • T1: In the operating room, just before anesthesia induction • T2: The day after surgery, at 8:00 a.m.
Serum cortisol and serum glucose levels will be measured to determine patients' stress levels. Increases in cortisol and glucose levels indicate increased stress levels.
Surgical Fear Level
Time frame: Patients' surgical fear levels will be measured at two different times. • T0: On the morning of surgery, in the ward at 8:00 a.m. • T1: In the operating room, just before anesthesia induction
The Surgical Fear Scale (SFS) will be used to determine the level of fear in patients. Surgical Fear Scale: The Surgical Fear Scale was first developed by Theunissen et al. in 2014 to determine the level of surgical fear in patients undergoing surgery. The Surgical Fear Scale consists of eight items and two subscales, scored from 0 to 10. The first four items measure fear of short-term surgical outcomes, and the last four items measure fear of long-term outcomes. Each subscale is aggregated, and the sum of the two subscale scores constitutes the total scale score. The total score for the scale ranges from 0 to 80. Low scores indicate low levels of surgical fear, while high scores indicate high levels of surgical fear.
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 2 Oct 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared due to patient confidentiality and privacy concerns, as well as institutional regulations regarding clinical data handling.
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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.
Erdoğan YAKIT study chair
BİTLİS EREN UNİVERSTY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing family-supported care in people with Bladder Tumor (TURBT) and Bladder (Urothelial, Transitional Cell) Cancer, run by Bitlis Eren University at 2 sites 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 11 inclusion and 5 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Erdoğan YAKIT (+905533601707, erdgnykt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Level (Visual Analogue Scale) (time frame: Anxiety levels will be measured at three different time points: T0: On the morning of the surgery, at 08:00 in the ward T1: In the operating room, immediately before anesthesia induction T2: The morning after the surgery, at 08:00). The study lists 3 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 2 Oct 2025.