ACL InjuryNCT05273463
Comparing Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes
A study testing Video-Based Intervention and Classroom-Based Intervention in people with ACL Injury and Anterior Cruciate Ligament Injuries, run by Mayo Clinic at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- ACL Injury, Anterior Cruciate Ligament Injuries
- What is being tested?
- Video-Based Intervention and Classroom-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- ACL Injury, Anterior Cruciate Ligament Injuries
- Being tested
- Video-Based Intervention, Classroom-Based Intervention
- Keywords
- ACL Reconstruction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Based InterventionBehavioural
15-minute video about what to expect before, during, and after your surgery
Classroom-Based InterventionBehavioural
Virtual 30-minute course with an Orthopedic nurse about what to expect before, during, and after your surgery
| Study group | Role | What they receive |
|---|---|---|
| Video-Based Education Group | Experimental | Approximately 4 weeks before scheduled surgery, participants will receive the video-based intervention regarding pre-and postoperative care for ACL reconstruction. Receives: Behavioral: Video-Based Intervention |
| Virtual Classroom Course Group | Experimental | Approximately 4 weeks before scheduled surgery, participants will receive the classroom-based intervention regarding pre-and postoperative care for ACL reconstruction. Receives: Behavioral: Classroom-Based Intervention |
| Standard of Care Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Knowledge Retention
Measured using the ACL Reconstruction Perioperative Education Quiz
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start23 Aug 2022
- Primary completion2 Dec 2025
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayley R. Powell, Mayo Clinic
- Investigators
- Hayley Powell, MSN, RN, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273463
- Sponsor's protocol ID
- 21-002443
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2022
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05273463
- Acronym / sponsor ID
- 21-002443
- Conditions
- ACL Injury, Anterior Cruciate Ligament Injuries
- Keywords
- ACL Reconstruction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Video-Based Education Group | Experimental | Behavioral: Video-Based InterventionApproximately 4 weeks before scheduled surgery, participants will receive the video-based intervention regarding pre-and postoperative care for ACL reconstruction. |
| Virtual Classroom Course Group | Experimental | Behavioral: Classroom-Based InterventionApproximately 4 weeks before scheduled surgery, participants will receive the classroom-based intervention regarding pre-and postoperative care for ACL reconstruction. |
| Standard of Care Group | No intervention | –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. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-Based Intervention15-minute video about what to expect before, during, and after your surgery | Behavioural | Video-Based Education Group |
| Classroom-Based InterventionVirtual 30-minute course with an Orthopedic nurse about what to expect before, during, and after your surgery | Behavioural | Virtual Classroom Course Group |
Primary outcome
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.
11 secondary outcomes
Anxiety
Time frame: 24 months
Self-Efficacy
Time frame: 24 months
Kinesiophobia
Time frame: 24 months
Physical Function
Time frame: 24 months
Knowledge Retention
Time frame: 24 months
Pain Interference
Time frame: 24 months
History of Falls
Time frame: 24 months
Lysholm Knee Score
Time frame: 24 months
Activity Level
Time frame: 24 months
Confidence in Returning to Sport
Time frame: 24 months
Resilience
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for ACL Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayley Powell, MSN, RN principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Based Intervention and Classroom-Based Intervention in people with ACL Injury and Anterior Cruciate Ligament Injuries, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.