NCT07277036

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 19, 2025

Last Update Submit

November 28, 2025

Conditions

Keywords

Video-assisted educationpatient educationdefecationself-carepostoperative recovery

Outcome Measures

Primary Outcomes (1)

  • Defecation Occurrence

    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 Outcomes (1)

  • Postoperative Nausea and Vomiting (Yes/No)

    At hospital discharge (postoperative day 0-1).

Other Outcomes (2)

  • Bathing With Family Assistance (Yes/No)

    Postoperative day 5-7 (follow-up)

  • Pain Intensity

    At hospital discharge (postoperative day 0-1).

Study Arms (2)

Video-Assisted Education

EXPERIMENTAL

Single-session video-assisted patient education in addition to routine postoperative instructions

Behavioral: Video-Assisted Patient Education

Usual Care

NO INTERVENTION

Routine postoperative discharge education without the video component.

Interventions

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.

Video-Assisted Education

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Tinaztepe University

Izmir, Buca, 35400, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 11, 2025

Study Start

October 1, 2023

Primary Completion

January 10, 2024

Study Completion

January 17, 2024

Last Updated

December 11, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Locations