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临床试验/NCT07277036
NCT07277036
已完成
不适用

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

Izmir Tinaztepe University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2023年10月1日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Izmir Tinaztepe University
入组人数
92
试验地点
1
主要终点
Defecation Occurrence

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Defecation Occurrence

时间窗: 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

次要结局

  • Postoperative Nausea and Vomiting (Yes/No)(At hospital discharge (postoperative day 0-1).)

研究者

发起方
Izmir Tinaztepe University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Berna Dizer

Assistant professor

Izmir Tinaztepe University

研究点 (1)

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