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Postoperative PainVITAPNCT07767344

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

A study testing Video-Based Preoperative Block Education and Standard Verbal Preoperative Block Education in people with Postoperative Pain and Laparoscopic Cholecystectomy Surgery, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Video-Based Preoperative Block Education and Standard Verbal Preoperative Block Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 Aug 2026to 13 Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Elective laparoscopic cholecystectomy

Who cannot join

  • Psychiatric disease
  • Anticoagulant use or coagulopathy
  • Allergy to local anesthetic
  • Infection at the block site
  • Thoracic deformity
  • Inability to comprehend pain or anxiety assessment scales.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sanliurfa Education and Research Hospital

    Sanliurfa, Eyyübiye, 63040

Other trials in Turkey (Türkiye)

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
Video-Based Preoperative Block Education, Standard Verbal Preoperative Block Education
Keywords
Laparoscopic cholecystectomy, TAP block, Video-based education, Preoperative education, Trust in Physician Scale, APAIS, Preoperative anxiety, Postoperative pain, Multimodal analgesia, Patient-centered outcomes, Randomized controlled trial
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video-Based Preoperative Block EducationBehavioural

    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.

  • Standard Verbal Preoperative Block EducationBehavioural

    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.

Study groups in NCT07767344
Study groupRoleWhat they receive
Standard Verbal Information GroupActive comparatorParticipants in this group will receive standard preoperative verbal information regarding the ultrasound-guided transversus abdominis plane (TAP) block. No additional video-based educational material will be provided. All patients will subsequently undergo standardized general anesthesia, multimodal analgesia, and bilateral ultrasound-guided TAP block.
Receives: Behavioral: Standard Verbal Preoperative Block Education
Video-Based Education GroupExperimentalParticipants in this group will receive standard preoperative verbal information plus a standardized educational video demonstrating ultrasound anatomy and probe positioning for the transversus abdominis plane (TAP) block. The video does not include invasive procedural steps. All patients will subsequently undergo standardized general anesthesia, multimodal analgesia, and bilateral ultrasound-guided TAP block.
Receives: Behavioral: Video-Based Preoperative Block Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trust in Physician

    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.

    Measured: Twenty-four hours after surgery

Secondary outcomes (4)
  1. Postoperative Pain

    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.

    Measured: Immediately after surgery, four hours after surgery, twelve hours after surgery, and twenty-four hours after surgery

  2. Preoperative Anxiety

    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.

    Measured: After completion of preoperative education intervention and approximately one hour before surgery

  3. Total Opioid Consumption

    Total postoperative opioid consumption will be recorded and converted to intravenous morphine equivalent doses for standardization across patients.

    Measured: First twenty-four hours after surgery

  4. Postoperative Nausea and Vomiting Incidence

    Incidence of postoperative nausea and vomiting will be recorded based on patient reports and clinical observation, including any need for antiemetic treatment.

    Measured: First twenty-four hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2026
  2. Study start12 Aug 2026
  3. Primary completion12 Oct 2026
  4. Study completion13 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07767344
Sponsor's protocol ID
HRÜ/26.05.01
Acronym
VITAP
Status last verified
Oct 2026
First submitted
11 Aug 2026
Last updated
14 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Video-Based Preoperative Block Education and Standard Verbal Preoperative Block Education in people with Postoperative Pain and Laparoscopic Cholecystectomy Surgery, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trust in Physician (time frame: Twenty-four hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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