Video-Assisted Education After Laparoscopic Cholecystectomy (VAE-LC)

November 28, 2025 updated by: Berna Dizer, Izmir Tinaztepe University

The Effect of Video-Assisted Education on Postoperative Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Brief Summary:

This randomized controlled trial aims to evaluate the effects of video-assisted preoperative education on postoperative physiological parameters and recovery outcomes in patients undergoing laparoscopic cholecystectomy. The study compares a video-based education program with brochure-based education covering pain and nausea-vomiting management, nutrition, early mobilization, fluid intake, wound care, bathing, and follow-up instructions in adults scheduled for elective laparoscopic cholecystectomy in a public state hospital in Türkiye.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Laparoscopic cholecystectomy is a widely used minimally invasive surgical method to treat gallstones. Effective preoperative education is critical to enhance postoperative recovery and reduce complications. This randomized controlled trial was conducted between October 1, 2023, and January 17, 2024, in the General Surgery Department of a public state hospital in Türkiye. The primary aim of the study is to determine the effects of video-assisted education on postoperative physiological parameters and recovery outcomes of patients undergoing laparoscopic cholecystectomy. A total of 92 adult patients scheduled for elective laparoscopic cholecystectomy are randomly assigned to an intervention group (n = 46) and a control group (n = 46) using a randomized allocation procedure. The intervention group receives structured video-assisted education, whereas the control group receives the same educational content through a printed brochure. The educational content includes information on postoperative pain and nausea-vomiting management, nutrition, early mobilization, adequate fluid intake, wound care, bathing, and follow-up instructions. Education is delivered preoperatively by a trained nurse.

Data are collected using a sociodemographic data form, the Visual Analog Scale (VAS) for pain, a pre-/postoperative patient assessment form, and a dietary habits questionnaire. Physiological parameters (vital signs, SpO₂, blood glucose), functional recovery indicators (defecation, mobilization, bathing), and selected self-care behaviors are assessed at predefined time points (preoperative baseline, discharge day, and postoperative follow-up day).

The primary outcomes are postoperative bowel recovery (e.g., presence and timing of defecation) and selected self-care-related recovery indicators (e.g., bathing status, need for family assistance). Secondary outcomes include postoperative nausea-vomiting, pain intensity, vital signs, and dietary habits. The study is designed to inform nursing practice regarding the use of video-assisted education compared with brochure-based education in patients undergoing laparoscopic cholecystectomy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Buca
      • Izmir, Buca, Turkey (Türkiye), 35400
        • Izmir Tinaztepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (≥18 years) undergoing elective laparoscopic cholecystectomy at the study hospital.
  • Able to provide written informed consent and to receive/understand the education materials.
  • Willing to complete postoperative assessments at discharge and on postoperative day 5-7

Exclusion Criteria:

  • Impaired consciousness, speech difficulties, hearing impairment, or diagnosed psychiatric conditions that would preclude receiving the educational intervention or valid assessment.

(Operational exclusions after enrollment): cancellation of surgery, refusal to continue participation, or incomplete data collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Video-Assisted Education
Single-session video-assisted patient education in addition to routine postoperative instructions
Behavioral: Video-Assisted Patient Education
Single-session video-assisted patient education delivered before hospital discharge after laparoscopic cholecystectomy. A standardized 10-15-minute video (shown on a tablet/TV by a nurse) covers postoperative care: pain control/analgesic use, early mobilization, wound care, diet/fluids, warning signs, and follow-up. Participants also receive routine discharge instructions; the video is an adjunct unique to this arm and is not provided to the control group.
No Intervention: Usual Care
Routine postoperative discharge education without the video component.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Defecation Occurrence
Time Frame: Postoperative day 5-7 (follow-up)
Proportion of participants who report at least one bowel movement by the follow-up day, recorded via the standardized patient assessment form. Higher proportions indicate faster gastrointestinal recovery. Groups compared: Video-Assisted Education vs. Usual Care
Postoperative day 5-7 (follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative Nausea and Vomiting (Yes/No)
Time Frame: At hospital discharge (postoperative day 0-1).
Any nausea or ≥1 vomiting episode on the day of discharge; proportions compared between groups.
At hospital discharge (postoperative day 0-1).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bathing With Family Assistance (Yes/No)
Time Frame: Postoperative day 5-7 (follow-up)
Need for family assistance during bathing at follow-up; proportions compared between groups.
Postoperative day 5-7 (follow-up)
Pain Intensity
Time Frame: At hospital discharge (postoperative day 0-1).
Mean VAS pain score (0=no pain, 10=worst pain); higher scores indicate worse pain
At hospital discharge (postoperative day 0-1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir Tinaztepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • İzmirTınaztepeÜ-B.Dizer-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The informed consent/IRB approval did not include permission for public deposition of individual participant-level data. In accordance with local privacy regulations (e.g., Türkiye's KVKK), IPD will not be shared. A de-identified minimal dataset supporting the main findings is available as Supplementary File S1; additional de-identified/aggregated data may be provided by the corresponding author upon reasonable request under a data-use agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings