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

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

Interventional

Enrollment (Actual)

92

Phase

  • 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

    • 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

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
Intervention / Treatment
Experimental: Video-Assisted Education
Single-session video-assisted patient education in addition to routine postoperative instructions
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

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

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

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.

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)

October 1, 2023

Primary Completion (Actual)

January 10, 2024

Study Completion (Actual)

January 17, 2024

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID 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.

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