Effectiveness of a Video-Based Educational Intervention Compared With In-Person Education on Psychosocial and Functional Outcomes in Patients Undergoing Arthroscopic Partial Meniscectomy: A Noninferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Pain Self-Efficacy Questionnaire (PSEQ)
研究概览
简要总结
The primary aim of the study is to investigate whether video-based education and exercise-program is non-inferior to in-person instructions in improving pain-related self-efficacy in patients undergoing arthroscopic partial meniscectomy in a day-hospital setting. Secondary aims are to explore the potential superiority of the video-based program compared to in-person instructions in reducing disability and kinesiophobia in the same patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for arthroscopic partial meniscectomy (medial or lateral meniscus) performed in a day-hospital setting.
- •Traumatic or degenerative meniscal tears.
- •Treatment at the Hip and Knee Orthopedic Unit of the Humanitas Clinical Institute.
- •Age ≥ 18 years.
- •Access to adequate video support.
- •Sufficient proficiency in the Italian language.
排除标准
- •Previous surgery on either knee within the past 5 years.
- •Significant postoperative hematoma requiring aspiration.
- •Neurological conditions potentially affecting functional or motor recovery.
- •Musculoskeletal conditions potentially affecting functional or motor recovery.
- •Rheumatologic conditions potentially affecting functional or motor recovery.
- •Internal medicine conditions potentially affecting functional or motor recovery.
- •Oncological conditions potentially affecting functional or motor recovery.
- •Cognitive or psychiatric disorders (Mini-Mental State Examination ≤ 21).
研究组 & 干预措施
Video-based group
Subjects assigned to this group will be asked to watch educational video within 5 days before surgery and to performe exercises shown in the video during the 2 weeks after surgery.
干预措施: Video-based education (Behavioral)
Control group
Subjects assigned to this group will be instructed in-person by a physiotherapist on educational advice and exercises to perform during the 2 weeks after surgery.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Pain Self-Efficacy Questionnaire (PSEQ)
时间窗: From enrolment to the 6 weeks after surgery
The PSEQ assesses patients' confidence in performing daily activities despite pain, with score ranging from 0 to 60 and higher scores indicating greater pain-related self-efficacy.
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(From enrolment to the 3 weeks after surgery)
- Tampa Scale of Kinesiophobia (TSK)(From enrolment to the 3 weeks after surgery)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(From enrolment to the 6 weeks after surgery)
- Tampa Scale of Kinesiophobia (TSK)(From enrolment to the 6 weeks after surgery)
- Pain Self-Efficacy Questionnaire (PSEQ)(From enrolment to the 3 weeks after surgery)