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Not yet recruiting 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

No phase Interventional Bladder Tumor (TURBT) Bladder (Urothelial, Transitional Cell) Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: family-supported care.
Who it may be relevant to
Registry conditions: Bladder Tumor (TURBT), Bladder (Urothelial, Transitional Cell) Cancer. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Behavioral family-supported care
    Family video calling in the operating room

Primary outcome measures

  • 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]
  • 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.]
  • 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]

Eligibility criteria

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Turkey (Türkiye) · 2 centers
  • Tatvan State Hospital, Bitlis, Turkey — Bitlis
  • Bitlis State Hospital, Bitlis, Turkey — Bitlis

Identifiers

NCT: NCT07203989 · HKU-2025-TURBT-FV-RCT01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗