Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06634615

The Effect of Patient Education and Family Interview Practices Using Virtual Reality on Patient Outcomes in Cholecystectomy Patients: A Randomized Controlled Trial

Led by Marmara University · Updated on 2025-05-09

60

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how patient education and family interview practices using virtual reality (VR) affect stress, anxiety, information needs, sleep quality, and satisfaction with surgery preparation in patients undergoing laparoscopic cholecystectomy. This randomized controlled experimental study aims to answer specific questions about differences in these outcomes among patients who receive VR education, VR family interviews, or routine care. The study includes 60 patients divided into three groups: control, education, and education plus interview. Participants will be assigned to one of three groups: control with routine care, education group shown a 2-3 minute animated VR video about laparoscopic cholecystectomy, or education plus interview group who receive the VR education plus a 5-minute VR family video call in the operating room waiting area. VR glasses (Oculus Quest 2) are used for the video and family interviews. The study includes a pilot phase and thorough disinfection procedures for VR equipment between uses. Patients will complete several assessments including stress levels, anxiety and information needs, sleep quality, and satisfaction at multiple time points: on the day of hospitalization, before surgery in the waiting area, and on the first postoperative day before discharge. Data will be collected via standardized forms and scales. Researchers will monitor participants’ experiences and responses to VR interventions throughout the hospital stay, focusing on changes in psychological and sleep-related outcomes tied to surgery preparation.

CONDITIONS

Brief Title

The Effect of Patient Education and in the Operating Room Family Interview Practices on Patient Outcomes Using Virtual Reality in Cholecystectomy Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who volunteer to participate in the study
  • Patients aged 18 years or older
  • Patients scheduled for elective laparoscopic cholecystectomy surgery
  • Patients without vision, hearing, or communication problems
  • Patients whose relatives have a smartphone and internet connection
  • Patients with stress intensity higher than 3 on a 1 to 10 scale
Not Eligible

You will not qualify if you...

  • Patients experiencing dizziness
  • Patients with psychiatric disorders
  • Patients with persistent sleep problems
  • Patients who voluntarily leave the study
  • Patients who interrupt the family video call with VR
  • Patients who feel discomfort during VR application
  • Patients developing allergy to VR goggle materials
  • Patients who fill out data collection forms incompletely or incorrectly

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) on the day of hospitalization

Education and Preoperative Preparation

Duration - From day of hospitalization until surgery day

Participants are introduced to the study and given education using a virtual reality patient education video about laparoscopic cholecystectomy. Participants in the education+interview group also have a 5-minute virtual reality family interview in the operating room waiting area.

Visits on the day of hospitalization and in the preoperative waiting area of the operating room

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Participants undergo laparoscopic cholecystectomy surgery followed by immediate post-operative care as part of routine hospital procedures.

1 visit on the surgery day (in-person)

Post-operative Assessment and Follow-up

Duration - 1 day post-surgery

On the morning of the first post-operative day before discharge, participants complete assessments regarding stress, anxiety, sleep quality, satisfaction with preparation, and virtual reality experience.

1 visit (in-person) on the first post-operative day before discharge

Trial Site Locations

Total: 1 location

1

Marmara University Pendik Training and Research Hospital Prof. Dr. Asaf Ataseven Additional Service Building

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

Ç

Çağla Islattı Mutlu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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