Multidimensional Impact Analysis of Interactive Video Health Intervention on Quality of Life and Clinical Rehabilitation Indicators in Patients With Early Postoperative Bowel Obstruction: A Randomized Controlled Tria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 462
- 试验地点
- 1
- 主要终点
- Quality of Life (QoL) Score
研究概览
简要总结
Objective: To investigate the multidimensional effects of an interactive video health intervention on the quality of life and clinical rehabilitation indicators of patients with early postoperative bowel obstruction.
Methods: The study consists of two phases. Phase 1 (January 2019-December 2020) involves the development and psychometric validation of a Postoperative Quality of Life Assessment Scale for Early Intestinal Obstruction, with approximately 150 patients. Phase 2 (January 2021-January 2025) is a randomized controlled trial enrolling about 310 eligible patients (aged 18-75 years, with basic cognitive ability, diagnosed with early postoperative bowel obstruction after abdominal surgery). Participants are randomly assigned to either a control group (conventional care, including condition monitoring, basic treatment, and non-structured health education) or a study group (conventional care plus an interactive video health intervention consisting of five modular videos covering disease knowledge, rehabilitation, and diet, initiated 24 hours post-surgery).
Primary and secondary outcomes will include quality of life (assessed with the validated scale), clinical rehabilitation indicators (such as obstruction relief time and hospitalization duration), electrogastrogram parameters, and gut microbiota diversity (16S rRNA sequencing).
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with early postoperative intestinal obstruction after abdominal surgery based on clinical symptoms, physical examination and imaging
- •Aged between 18 and 75 years
- •With basic cognitive ability and comprehension
- •Informed consent obtained directly from patients; family members provided supplementary consent
排除标准
- •Serious underlying diseases
- •Serious mental diseases
- •Audio-visual impairment that prevents normal reception of interactive video information
- •Poor compliance
结局指标
主要结局
Quality of Life (QoL) Score
时间窗: Baseline (pre-intervention, within 24 hours after surgery) and at hospital discharge (average 8-10 days after randomization).
Scale consists of multiple domains assessing physical, psychological, and social functioning. Scores range from 0 to 100, with higher scores indicating better quality of life.
次要结局
- Time to Relief of Intestinal Obstruction(From randomization to hospital discharge (daily assessment, average 8-10 days))
- Duration of Hospitalization(From the day of surgery through hospital discharge (an average of 7-10 days))
- Electrogastrogram (EGG) Parameters - Gastric Antrum Slow-Wave Amplitude(24 hours post-intervention initiati)
- Electrogastrogram (EGG) Parameters - Gastric Slow-Wave Frequency(24 hours post-intervention initiation and)
- Title: Gut Microbiota Diversity (Shannon Index)(First postoperative defecation (typically 3-5 days post-surgery))
研究者
Li Zhang
Principal Investigator
Changsha Fourth Hospital