Comparing Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes

Comparison of Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes: A Randomized Controlled Trial

The purpose of this research is to find out whether the way information about surgery is presented to patients affects patient satisfaction, knowledge retention, and surgical outcomes such as anxiety

Study Overview

• Status: Active, not recruiting
• Conditions: Anterior Cruciate Ligament Injuries; ACL Injury
• Intervention / Treatment: Behavioral: Video-Based Intervention; Behavioral: Classroom-Based Intervention

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients of Senior Attending orthopedic sports medicine surgeons at Mayo Clinic Arizona
• Patients with a proficiency in English in order to participate without need for translator.
• Patients with a diagnosis of a primary ACL injury in need of surgical reconstruction utilizing any surgical technique for ACL reconstruction.

Exclusion Criteria:

• Patients with a diagnosis of ACL injury in need of a surgical revision.
• Patients who have any multi-ligamentous injuries to the knee requiring modified postoperative unloading.
• Patients who have history of previous anterior cruciate ligament reconstructions in either leg.
• Patients who have either auditory or visual impairments.
• Patients who are medical professionals with work-related knowledge of ACL reconstruction.
• Patients with an inability or unwillingness of individual or legal guardian to give written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video-Based Education Group; Approximately 4 weeks before scheduled surgery, participants will receive the video-based intervention regarding pre-and postoperative care for ACL reconstruction.	Behavioral: Video-Based Intervention; 15-minute video about what to expect before, during, and after your surgery
Experimental: Virtual Classroom Course Group; Approximately 4 weeks before scheduled surgery, participants will receive the classroom-based intervention regarding pre-and postoperative care for ACL reconstruction.	Behavioral: Classroom-Based Intervention; Virtual 30-minute course with an Orthopedic nurse about what to expect before, during, and after your surgery
No Intervention: Standard of Care Group; Participants will receive verbal and written pre-and postoperative instruction as typically received by all ACL reconstruction patients treated by the attending physicians before and after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Measured using the Leiden Perioperative Patient Satisfaction Questionnaire. Self-reported questionnaire that rates the subjects satisfaction with information provision, discomfort and needs during perioperative care.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Measured using the PROMIS Emotional Distress - Anxiety Short Form 8a. Self-reported 8-item questionnaire that rates the subjects emotional distress in the past 7 days on a scale of 1=Never to 5=Always. Higher total scores indicate higher anxiety severity.	24 months
Self-Efficacy	Measured using the PROMIS Self-Efficacy - Manage Symptoms Short Form 8a. Self-reported 8-item questionnaire that rates the subjects current level of confidence to statements about managing symptoms using a scale of 1="I am not at all confident to 5="I am very confident". Higher total score indicate higher confidence in managing symptoms.	24 months
Kinesiophobia	Measured using the Tampa Scale for Kinesiophobia. Self-reported 17-item questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance using a scale of 1=Strongly Disagree to 4=Strongly Agree. Total score range from 17-68 and higher scores indicate severe kinesiophobia.	24 months
Physical Function	Measured using the PROMIS Physical Function Short Form 10b. Self-reported 10-item questionnaire that rates the subjects ability to perform an activity using a scale of 5="Without any difficulty" to 1="Unable to do". Higher total scores indicate higher physical function.	24 months
Knowledge Retention	Measured using the ACL Reconstruction Perioperative Education Quiz	24 months
Pain Interference	Measured using the PROMIS Pain Interference Short Form 6a. Self-reported 6-item questionnaire that rates the subjects pain interference with activities in the past 7 days using a scale of 1="Not at all" to 5="Very much". Higher total scores indicate higher pain interference with activities experienced.	24 months
History of Falls	Measured using the History of Falls Questionnaire. Self-reported 5-item questionnaire asking subjects about falls experienced in the past month and seriousness.	24 months
Lysholm Knee Score	Measured using the Lysholm Knee Scoring Scale. Self-reported questionnaire that asks subjects to indicate which statement best describes their condition in regards to common complaints frequently experience with knee problems. Total scoring out of 100 and higher score less knee-specific symptoms.	24 months
Activity Level	Measured using the Tegner Activity Scale. Self-reported level of activity prior to injury and post injury. Total of 10 levels and higher levels indicate greater activity level.	24 months
Confidence in Returning to Sport	Measured using the ACL Return to Sport Index. Self-reported 6-item questionnaire to measure the readiness to return to sports after ACL injury or reconstruction. Using a scale from 0 points (extremely negative psychological responses) to 100 points (no negative psychological responses).	24 months
Resilience	Measured using the Brief Resilience Scale. Self-reported 6-item questionnaire to measure perceived ability to recover from stress. Total score range 1-5 with higher scores indicating higher resilience.	24 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Hayley Powell, MSN, RN, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Actual): December 2, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ACL Reconstruction
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 21-002443

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No