Menu
Recruiting NCT06382324

The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction

No phase Interventional Anterior Cruciate Ligament (Acl) Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mindfulness practice of body scan, listening to light music.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament (Acl) Reconstruction. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Anterior cruciate ligament (ACL) reconstruction surgery is a common procedure performed by orthopedic surgeons. Postoperatively, patients often experience pain, muscle tension, and concerns about their ability to return to sports. These factors influence the recovery and return to sports capabilities of ACL patients. According to research, only 64% of patients are able to recover to their pre-injury level after surgery, and the success rate for returning to competitive sports is only 56%. Psychological factors during the recovery process may explain this disparity. ACL injury is associated with anxiety, pain reaction, and emotional disorders, with fear of re-injury being the most common obstacle to returning to sports, accounting for 19%. A study by Lentz et al. (2015) also found no significant differences in pain assessments between individuals who were afraid of re-injury and those who were able to return to sports at six months and one year after surgery. This suggests that fear of pain may limit activity and increase the risk of unsuccessful return to sports. Mindfulness intervention is a psychological approach that involves non-judgmental awareness and focus on moment to moment. Mindfulness practice is known to reduce stress in athletes, promote recovery, enhance athletic performance, and improve sleep quality. Good sleep quality contributes to emotional stability and physical recovery. Even short daytime naps can be beneficial for athletes. A review of 37 studies of moderate quality found that daytime napping can improve physical and cognitive performance, psychological state, and nighttime sleep. Therefore, investigators hypothesize that integrating mindfulness practice into daytime napping may lead to improved spirit upon waking, reduce sleep inertia, and over time, potentially increase the rate of return to sports after ACL reconstruction.

Interventions

  • Behavioral mindfulness practice of body scan
    Mindfulness intervention is one kind of psychological intervention. The founder of Mindfulness-Based Stress Reduction (MBSR), Jon Kabat-Zinn, described mindfulness as \"awareness that arises through paying attention, on purpose, in the present moment, non-judgmentally\" (Kabat-Zinn, 2003). Moreover, these attitudes can be nurtured through various practices such as body scan, meditation, yoga, mindful eating, and mindful walking. Mindfulness practices are recognized for their ability to a
  • Behavioral listening to light music
    listening to light music asa control

Primary outcome measures

  • Electroencephalogram (EEG) [Time frame: 5 times in one month after ACL reconstruction]
  • Electrooculography (EOG) [Time frame: 5 times in one month after ACL reconstruction]
  • Electromyography (EMG) [Time frame: 5 times in one month after ACL reconstruction]
  • ECG (Electrocardiography) [Time frame: 5 times in one month after ACL reconstruction]
  • Nasal/Oral airflow [Time frame: 5 times in one month after ACL reconstruction]
  • Thermistor [Time frame: 5 times in one month after ACL reconstruction]
  • Chest and abdominal belt [Time frame: 5 times in one month after ACL reconstruction]
  • Oximetry [Time frame: 5 times in one month after ACL reconstruction]
  • Snoring [Time frame: 5 times in one month after ACL reconstruction]
Secondary outcome measures (4)
  • Karolinska Sleepiness Scale (KSS) [Time frame: 5 times in one month after ACL reconstruction]
  • Five Facet Mindfulness Questionnaire (FFMQ) [Time frame: before and after five times in one month after ACL reconstruction, 6-month, 12-month follow-up]
  • State-Trait Anxiety Inventory (STAIS) [Time frame: before and after five times in one month after ACL reconstruction, 6-month, 12-month follow-up]
  • Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI) (Short Version) [Time frame: before and after five times in one month after ACL reconstruction, 6-month, 12-month follow-up]

Eligibility criteria

Inclusion criteria

  • Within the first month after ACL reconstruction without mindfulness practice experience

Exclusion criteria

  • below 18 years old, previous exposure to mindfulness intervention

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • ChangGungMH — Keelung

Identifiers

NCT: NCT06382324 · 202301280B0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗