- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07277036
Video-Assisted Education After Laparoscopic Cholecystectomy (VAE-LC)
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Buca
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Izmir, Buca, Turkey (Türkiye), 35400
- Izmir Tinaztepe University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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