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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Istituto Clinico Humanitas
- Enrollment
- 166
- Locations
- 1
- Primary Endpoint
- Pain Self-Efficacy Questionnaire (PSEQ)
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Arms & Interventions
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.
Intervention: 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.
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: 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.
Secondary Outcomes
- 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)