Clinical trial NCT06382324: The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction
Official title: The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament (Acl) Reconstruction
Keywords: Mindfulness
Napping
ACL injury
Return-to-sport
Polysomnography
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention method:

* Mindfulness napping group: listening to a record of mindfulness meditation practice for 40 minutes.
* Control group: listening to light music for 40 minutes.
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Electroencephalogram (EEG)
timeFrame: 5 times in one month after ACL reconstruction
measure: Electrooculography (EOG)
timeFrame: 5 times in one month after ACL reconstruction
measure: Electromyography (EMG)
timeFrame: 5 times in one month after ACL reconstruction
measure: ECG (Electrocardiography)
timeFrame: 5 times in one month after ACL reconstruction
measure: Nasal/Oral airflow
timeFrame: 5 times in one month after ACL reconstruction
measure: Thermistor
timeFrame: 5 times in one month after ACL reconstruction
measure: Chest and abdominal belt
timeFrame: 5 times in one month after ACL reconstruction
measure: Oximetry
timeFrame: 5 times in one month after ACL reconstruction
measure: Snoring
timeFrame: 5 times in one month after ACL reconstruction
Secondary outcomes:
measure: Karolinska Sleepiness Scale (KSS)
timeFrame: 5 times in one month after ACL reconstruction
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: before and after five times in one month after ACL reconstruction, 6-month, 12-month follow-up
measure: State-Trait Anxiety Inventory (STAIS)
timeFrame: before and after five times in one month after ACL reconstruction, 6-month, 12-month follow-up
measure: Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI) (Short Version)
timeFrame: before and after five times in one month after ACL reconstruction, 6-month, 12-month follow-up
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: ChangGungMH
Study officials:
References: