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Impact of Video-Based Patient Education on Physician Trust, Pain, and Anxiety in Laparoscopic Cholecystectomy

Study acronym: VITAP
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed
    • Enrollment target: estimated 62 to confirmed 61
    • Site details revised
  2. Minor Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description revised
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Notable Recruitment opened
    • Site details revised
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This prospective, randomized, single-center, single-blind study aims to evaluate the effects of video-based preoperative education on physician trust, postoperative pain, anxiety, and opioid consumption in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Sixty-two ASA I-II patients aged 18-65 years will be randomized into two groups: standard verbal information alone or verbal information plus a standardized educational video regarding ultrasound-guided transversus abdominis plane (TAP) block. All patients will receive standardized general anesthesia, multimodal analgesia, and bilateral TAP block. The primary outcome will be physician trust assessed at postoperative 24 hours using the Trust in Physician Scale. Secondary outcomes include preoperative anxiety measured with the Amsterdam Preoperative Anxiety and Information Scale (APAIS), postoperative pain scores, opioid consumption, rescue analgesic requirement, and postoperative nausea and vomiting incidence. The study hypothesizes that video-based education will improve physician trust and perioperative patient-centered outcomes.
Trial Details
NCT Number NCT07767344
Lead Sponsor Sanliurfa Education and Research Hospital
Conditions
(from sponsor)
Postoperative Pain, Laparoscopic Cholecystectomy Surgery, Preoperative Anxiety, Trust in Healthcare System, Regional Anesthesia, Transversus Abdominis Plane Block (TAP Block)
Related terms Postoperative Pain
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov