The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament (Acl) Reconstruction Clinical Trial

Official title:

The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06382324
• Other study ID #: 202301280B0
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Chang Gung Memorial Hospital
• Contact: Jain-Hong Chen
• Phone: 096-130-7506
• Email: psydr.jc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• below 18 years old, previous exposure to mindfulness intervention

Related Conditions & MeSH terms

• Anterior Cruciate Ligament (Acl) Reconstruction

Intervention

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 alleviate stress among athletes and enhance their recovery capabilities (Li et al., 2019). Mindfulness practice has been shown to enhance athletes' performance (Chen et al., 2018)? improve sleep quality (Rusch et al., 2019),which in turn promotes emotional stability and physical recovery.
• listening to light music
listening to light music asa control

Locations

Country	Name	City	State
Taiwan	ChangGungMH	Keelung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroencephalogram (EEG)	Electroencephalogram (EEG) is used to monitors patient's brain activities	5 times in one month after ACL reconstruction
Primary	Electrooculography (EOG)	Electrooculography (EOG) is a technique for measuring the movements of the human eyes. This helps to determine when REM sleep occurs, of which rapid eye movements are characteristic, and also essentially aids in determining when sleep occurs.	5 times in one month after ACL reconstruction
Primary	Electromyography (EMG)	Electromyography (EMG) is for evaluating and recording the electrical activity produced by skeletal muscles, uses four electrodes to measure muscle tension in the body as well as to monitor for an excessive amount of leg movements during sleep. Which are placed on patient's chim, R.anterior tibialis and L.anterior tibialis.	5 times in one month after ACL reconstruction
Primary	ECG (Electrocardiography)	ECG (Electrocardiography) measure the electrical activity of the heart.	5 times in one month after ACL reconstruction
Primary	Nasal/Oral airflow	Nasal/Oral airflow measured using pressure transducers, and/or a thermocouple, fitted in or near the nostrils	5 times in one month after ACL reconstruction
Primary	Thermistor	Thermistors are composed of a material that changes electrical resistance when exposed to temperature changes. As with the thermocouple, the temperature changes are sampled under a patient's nose or in front of the mouth.	5 times in one month after ACL reconstruction
Primary	Chest and abdominal belt	Chest and abdominal belt measured in concert with nasal/oral airflow by the use of belts. These belts expand and contract upon breathing effort.	5 times in one month after ACL reconstruction
Primary	Oximetry	Oximetry determines changes in blood oxygen levels which fits over a fingertip.	5 times in one month after ACL reconstruction
Primary	Snoring	Snoring and other noises. recorded with a sound probe over the neck.	5 times in one month after ACL reconstruction
Secondary	Karolinska Sleepiness Scale (KSS)	The Karolinska Sleepiness Scale (KSS) was developed by Akerstedt and Gillberg in 1990. This scale uses a 1 to 9 scoring system where participants rate their current level of sleepiness. A lower score indicates higher alertness, while a higher score signifies increased somnolence.; The Karolinska Sleepiness Scale (KSS) was developed by Akerstedt and Gillberg in 1990. This scale uses a 1 to 9 scoring system where participants rate their current level of sleepiness. A lower score indicates higher alertness, while a higher score signifies increased somnolence.	5 times in one month after ACL reconstruction
Secondary	Five Facet Mindfulness Questionnaire (FFMQ)	The FFMQ is a widely used self-report measure designed to assess an individual's mindfulness abilities and practices. It evaluates mindfulness across five specific facets, each representing a distinct aspect of mindfulness. n Observing: This facet involves paying attention to both external stimuli and internal experiences, such as thoughts and sensations, without judgment. n Describing: Participants describe their experiences, emotions, and thoughts with words and labels. It reflects the ability to put experiences into words. n Acting with Awareness: This facet measures the degree to which individuals engage in their daily activities with full presence and attention, avoiding automatic or mindless behaviors. n Non-Judging of Inner Experience: Participants evaluate their thoughts and feelings with an open and non-judgmental attitude, without labeling them as good or bad. n Non-reactivity to Inner Experience: This facet assesses an individual's ability to let thoughts and emotions arise	before and after five times in one month after ACL reconstruction, 6-month, 12-month follow-up
Secondary	State-Trait Anxiety Inventory (STAIS)	The STAI refers to a psychological assessment tool used to measure anxiety in adults. It consists of two separate subscales: the State Anxiety (S-Anxiety) subscale and the Trait Anxiety (T-Anxiety) subscale. Here's an overview of each subscale's content. S-Anxiety Subscale evaluates a person's current, temporary feelings of anxiety, which can vary based on situational factors. It consists of 20 items that describe how individuals feel at the present moment. Respondents rate their agreement with statements like "I am tense" or "I am worried" on a 4-point scale, ranging from "Not at all" to "Very much so." Higher scores indicate higher levels of current anxiety.	before and after five times in one month after ACL reconstruction, 6-month, 12-month follow-up
Secondary	Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI) (Short Version)	The ACL-RSI is presently utilized for predicting the likelihood of athletes not returning to sport. It includes a series of questions that inquire about an individual's emotions, thoughts, and concerns related to their return to sports. It assesses aspects such as fear of reinjury, confidence in the injured knee's stability, perceived psychological readiness, and perceived risk of returning to sports. Participants rate their responses with higher scores indicating greater confidence and readiness to return to sports. Webster and Feller validated the short form of ACL-RSI, demonstrating its strong internal consistency and reliability in predicting return-to-sport outcomes, which was comparable to the full version. They also confirmed the validity of the abbreviated ACL-RSI version, proposing that athletes achieving scores exceeding 60% at 6 months post-surgery were significantly inclined to return to sport within 12 months. Conversely, individuals scoring below 39 points were less like	before and after five times in one month after ACL reconstruction, 6-month, 12-month follow-up