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

NCT ID: NCT07203989

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-09-15

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental - Intervention Group

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.

Group Type EXPERIMENTAL

family-supported care

Intervention Type BEHAVIORAL

Family video calling in the operating room

Control Group

Standard Maintenance: Patients will undergo the standard surgical preparation and waiting process in the operating room without any contact with family members.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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family-supported care

Family video calling in the operating room

Intervention Type BEHAVIORAL

Other Intervention Names

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Family video calling in the operating room

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitlis Eren University

OTHER

Sponsor Role lead

Responsible Party

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Erdogan Yakit

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erdoğan YAKIT

Role: STUDY_CHAIR

BİTLİS EREN UNİVERSTY

Locations

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Tatvan State Hospital, Bitlis, Turkey

Bitlis, Tatvan, Turkey (Türkiye)

Site Status

Bitlis State Hospital, Bitlis, Turkey

Bitlis, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Erdoğan YAKIT

Role: CONTACT

+905533601707

Aynur KOYUNCU

Role: CONTACT

0539 855 50 92

Other Identifiers

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HKU-2025-TURBT-FV-RCT01

Identifier Type: -

Identifier Source: org_study_id

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