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

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 9, 2025 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Nov 2024 to Jan 5, 2025v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2024 to Jan 5, 2025
  3. Minor Eligibility criteria shortened, about 3 words Study title shortened, about 4 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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This study was planned to be a randomized controlled experimental study to determine the effect of patient education and family interview practices using virtual reality on stress intensity, anxiety and information need levels, sleep quality and satisfaction with the preparation process for surgery in cholecystectomy patients. The main questions it aims to answer are: * Is there a significant difference in stress intensity, anxiety, and information need levels between patients who received and did not receive patient education with VR glasses in the ward before cholecystectomy surgery? * Is there a significant difference in stress intensity and anxiety levels between patients who received and did not receive video family interviews with VR glasses in the operative waiting area before cholecystectomy surgery? * Is there a significant difference in stress intensity, anxiety, and sleep quality levels at discharge of groups that received different VR interventions? * What is the postoperative sleep quality of patients with low preoperative anxiety levels? * What is the satisfaction of patients who received VR with the surgery preparation process? The patients participating in the study will be numbered according to the order of hospitalization and assigned to one of the control, education, education+interview groups in accordance with the randomization list. Face-to-face communication will be established with each patient in the ward on the day of hospitalization, in the preoperative waiting area when they come to the operating room and in the ward on the day of discharge. Depending on the groups in which the patients are included, they will be shown an educational video using virtual reality goggles and/or will be allowed to meet with their families. No application will be made to the control group and the ward routine will continue.
Trial Details
NCT Number NCT06634615
Lead Sponsor Marmara University
Conditions Cholecystectomy, Laparoscopic, Virtual Reality, Patient Education, Family Interviews, Operating Room, Anxiety, Stress, Sleep Quality +2 more
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov