Sanliurfa Education and Research Hospital
Sanliurfa, Eyyübiye, 63040, Turkey (Türkiye)
Location contact
Melike Bostancı Erkmen, M.D.
SUB_INVESTIGATOR
Servet Sürmeli, M.D.
SUB_INVESTIGATOR
Tolga Karaçay
CONTACT
NCT Number: NCT07767344
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 opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Sanliurfa, Eyyübiye, 63040, Turkey (Türkiye)
Melike Bostancı Erkmen, M.D.
SUB_INVESTIGATOR
Servet Sürmeli, M.D.
SUB_INVESTIGATOR
Tolga Karaçay
CONTACT
Laparoscopic cholecystectomy (LC) is associated with less postoperative pain compared with open cholecystectomy; however, postoperative pain of varying severity may still occur due to pneumoperitoneum, surgical manipulation, and patient-related factors. Multimodal analgesia strategies including systemic non-opioid analgesics, opioids, local anesthetic infiltration, and interfascial plane blocks are widely recommended for postoperative pain management after LC. Inadequate pain control may prolong hospital stay, increase morbidity, and elevate healthcare costs.
Ultrasound-guided transversus abdominis plane (TAP) block has become an important component of perioperative analgesia in abdominal surgery by reducing opioid consumption and improving recovery quality. Current PROSPECT recommendations support the use of TAP block as an effective regional analgesia technique following laparoscopic cholecystectomy.
Beyond pharmacological and regional analgesic techniques, patient-related psychosocial factors may significantly influence perioperative outcomes. Physician trust has been shown to affect treatment adherence, perceived quality of care, pain perception, and functional recovery. Similarly, preoperative anxiety may influence postoperative pain intensity and patient satisfaction. The Trust in Physician Scale and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) are validated instruments commonly used to assess physician trust and preoperative anxiety, respectively.
Video-based preoperative education has emerged as a standardized and visually supported educational tool that may reduce anxiety, improve patient satisfaction, optimize patient expectations, and strengthen physician-patient relationships. Digital multimedia platforms are increasingly utilized in medical education, including procedural education for regional anesthesia techniques. However, there is limited evidence evaluating the impact of video-based education on patient-centered outcomes in the context of regional anesthesia.
The primary objective of this study is to determine whether video-based preoperative education regarding TAP block improves physician trust compared with standard verbal information alone in patients undergoing laparoscopic cholecystectomy. Secondary objectives are to evaluate the effects of video-based education on postoperative pain scores, opioid consumption, rescue analgesic requirement, postoperative nausea and vomiting (PONV), and preoperative anxiety levels.
This study is designed as a prospective, randomized, single-center, single-blind controlled trial. A total of 62 patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II scheduled for elective laparoscopic cholecystectomy will be enrolled. Exclusion criteria include psychiatric disease, anticoagulant use or coagulopathy, allergy to local anesthetics, infection at the block site, thoracic deformity, and inability to comprehend pain or anxiety assessment scales.
Participants will be randomized into two groups using a sealed-envelope method:
Control group: standard verbal preoperative information about TAP block Video group: standard verbal information plus a standardized educational video demonstrating ultrasound anatomy and probe positioning for TAP block without showing invasive procedural steps
Approximately one hour before surgery, preoperative anxiety will be evaluated using the APAIS questionnaire. All patients will undergo standardized general anesthesia and receive multimodal analgesia including dexketoprofen and tramadol before the end of surgery. Ultrasound-guided bilateral TAP block will be performed in all patients.
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) at 0, 4, 12, and 24 hours postoperatively. Rescue analgesic requirements and total opioid consumption converted to intravenous morphine equivalents will be recorded. Physician trust will be assessed at postoperative 24 hours using the Trust in Physician Scale and will serve as the primary endpoint. Secondary endpoints include postoperative NRS pain scores, opioid consumption, preoperative anxiety scores, rescue analgesic requirement, and incidence of postoperative nausea and vomiting.
Sample size calculation will be performed using G*Power software based on pilot data, and 31 patients will be included in each group considering possible dropouts. Statistical analyses will be conducted using SPSS software. Normality of data distribution will be assessed with the Shapiro-Wilk test. Appropriate parametric or non-parametric statistical tests will be used accordingly, and a p-value <0.05 will be considered statistically significant.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive standard preoperative verbal information plus a standardized educational video. The video demonstrates ultrasound anatomy and probe positioning for the transversus abdominis plane (TAP) block without showing invasive needle insertion or procedural performance. The content is designed to improve patient understanding of the regional anesthesia technique while maintaining procedural safety and standardization.
Participants randomized to this group will receive standardized preoperative verbal education regarding the ultrasound-guided transversus abdominis plane (TAP) block. The explanation will be delivered by an anesthesiologist using a consistent script and will include the purpose of the block, expected analgesic benefits, and general procedural overview without the use of any visual, video, or multimedia materials. After preoperative education, all patients will undergo standardized general anesthesia, multimodal analgesia, and bilateral ultrasound-guided TAP block as part of routine perioperative care.
Time frame: Twenty-four hours after surgery
Physician trust will be assessed using the Trust in Physician Scale. The scale evaluates patients' trust in their treating physician regarding communication, competence, and reliability. Higher scores indicate greater trust in the physician.
Time frame: Immediately after surgery, four hours after surgery, twelve hours after surgery, and twenty-four hours after surgery
Postoperative pain will be assessed using the Numeric Rating Scale ranging from zero to ten, where zero indicates no pain and ten indicates the worst imaginable pain. Pain scores will be recorded at predefined postoperative time points.
Time frame: After completion of preoperative education intervention and approximately one hour before surgery
Preoperative anxiety will be measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). This validated questionnaire assesses anxiety levels and information requirement related to surgery and anesthesia. The scale will be used to evaluate the effect of preoperative educational intervention (standard verbal information or video-based education) on patient anxiety levels.
Time frame: First twenty-four hours after surgery
Total postoperative opioid consumption will be recorded and converted to intravenous morphine equivalent doses for standardization across patients.
Time frame: First twenty-four hours after surgery
Incidence of postoperative nausea and vomiting will be recorded based on patient reports and clinical observation, including any need for antiemetic treatment.
Contact information is provided by the study sponsor or research team.
Sanliurfa Education and Research Hospital
Other Gov
The Effect of Video-Based Preoperative Patient Education on Physician Trust, Postoperative Pain, and Anxiety Levels in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Acronym: VITAP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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