Effect of Intraoperative Live Video Viewing on Kinesiophobia After ACL Reconstruction (NCT07540715) | Clinical Trial Compass
CompletedNot Applicable
Effect of Intraoperative Live Video Viewing on Kinesiophobia After ACL Reconstruction
Turkey (Türkiye)65 participantsStarted 2023-01-01
Plain-language summary
The purpose of this randomized controlled trial is to investigate whether intraoperative live arthroscopic video viewing improves postoperative psychological and functional outcomes in patients undergoing primary anterior cruciate ligament (ACL) reconstruction under spinal anesthesia Participants are randomly assigned to either a video-viewing group, where they watch their surgery in real-time, or a control group receiving standard care without visual feedback The primary objective is to determine whether this patient-specific visual biofeedback reduces postoperative kinesiophobia at 24 weeks.
Secondary objectives aim to evaluate the intervention's effects on state anxiety, illness perception, postoperative pain, and patient-reported functional recovery, including IKDC, Lysholm, and SF-36 scores
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Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 years and older.
* Diagnosis of isolated anterior cruciate ligament (ACL) rupture.
* Scheduled to undergo primary arthroscopic ACL reconstruction under spinal anesthesia.
Exclusion Criteria:
* Concomitant knee injuries requiring additional surgical procedures that substantially alter early postoperative weight-bearing and rehabilitation (e.g., meniscal repair or microfracture)
* Multiligament injury or posterior cruciate ligament (PCL) injury.
* Advanced chondral damage, rheumatologic disease, bleeding diathesis, or active local/systemic infection
* Psychiatric disorders requiring active treatment
* Inability to remain conscious, cooperative, and communicative throughout the procedure (e.g., developing deep sedation with a Ramsay score \>2 or requiring conversion to general anesthesia)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tampa Scale of Kinesiophobia (TSK-11) Score
Timeframe: Preoperative (baseline), 4 weeks postoperatively, and 24 weeks postoperatively