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

NCT07203989 | Not Yet Recruiting

• 1 other identifier: HKU-2025-TURBT-FV-RCT01
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Bladder Tumor (TURBT); Bladder (Urothelial, Transitional Cell) Cancer

Keywords

Transurethral resection of bladder tumor (TURBT); Preoperative anxiety; Surgical fear; Family-centered care; Video call intervention

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

Study Arms (2)

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.

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.

Interventions

family-supported care BEHAVIORAL

Family video calling in the operating room

Also known as: Family video calling in the operating room

Experimental - Intervention Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (2)

Tatvan State Hospital, Bitlis, Turkey

Bitlis, Tatvan, Turkey (Türkiye)

Location

Bitlis State Hospital, Bitlis, Turkey

Bitlis, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Erdoğan YAKIT

  BİTLİS EREN UNİVERSTY

  STUDY CHAIR

Central Study Contacts

Erdoğan YAKIT

CONTACT

+905533601707; erdgnykt@gmail.com

Aynur KOYUNCU

CONTACT

0539 855 50 92; aynur.koyuncu@hku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)