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NCT Number: NCT05273463

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video-Based Intervention

Behavioral

15-minute video about what to expect before, during, and after your surgery

Classroom-Based Intervention

Behavioral

Virtual 30-minute course with an Orthopedic nurse about what to expect before, during, and after your surgery

Primary outcomes

  1. Patient Satisfaction

    Time frame: 24 months

    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.

Secondary outcomes

  1. Anxiety

    Time frame: 24 months

    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.

  2. Self-Efficacy

    Time frame: 24 months

    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.

  3. Kinesiophobia

    Time frame: 24 months

    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.

  4. Physical Function

    Time frame: 24 months

    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.

  5. Knowledge Retention

    Time frame: 24 months

    Measured using the ACL Reconstruction Perioperative Education Quiz

  6. Pain Interference

    Time frame: 24 months

    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.

  7. History of Falls

    Time frame: 24 months

    Measured using the History of Falls Questionnaire. Self-reported 5-item questionnaire asking subjects about falls experienced in the past month and seriousness.

  8. Lysholm Knee Score

    Time frame: 24 months

    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.

  9. Activity Level

    Time frame: 24 months

    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.

  10. Confidence in Returning to Sport

    Time frame: 24 months

    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).

  11. Resilience

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 10, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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