Anterior Cruciate Ligament (Acl) ReconstructionNCT06382324
The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction
A study testing mindfulness practice of body scan and listening to light music in people with Anterior Cruciate Ligament (Acl) Reconstruction, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anterior Cruciate Ligament (Acl) Reconstruction
- What is being tested?
- mindfulness practice of body scan and listening to light music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Apr 2024to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Within the first month after ACL reconstruction without mindfulness practice experience
Who cannot join
- below 18 years old, previous exposure to mindfulness intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
ChangGungMH
Keelung, Taiwan, 204004
Jian-Hong Chen, 096-130-7506, psydr.jc@gmail.com
Chang Gung Memorial Hospital
About this study
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.
- Being tested
- mindfulness practice of body scan, listening to light music
- Keywords
- Mindfulness, Napping, ACL injury, Return-to-sport, Polysomnography
- 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.
mindfulness practice of body scanBehavioural
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 musicBehavioural
listening to light music asa control
| Study group | Role | What they receive |
|---|---|---|
| intervention arem | Experimental | The patient randomized in the intervention arm will listen to the records of body scan for 40 minutes with polysomnography evaluation Receives: Behavioral: mindfulness practice of body scan |
| control arm | Placebo comparator | listening to light music for 40 minutes with polysomnography evaluation Receives: Behavioral: listening to light music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalogram (EEG)
Electroencephalogram (EEG) is used to monitors patient's brain activities
Measured: 5 times in one month after ACL reconstruction
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.
Measured: 5 times in one month after ACL reconstruction
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.
Measured: 5 times in one month after ACL reconstruction
ECG (Electrocardiography)
ECG (Electrocardiography) measure the electrical activity of the heart.
Measured: 5 times in one month after ACL reconstruction
Nasal/Oral airflow
Nasal/Oral airflow measured using pressure transducers, and/or a thermocouple, fitted in or near the nostrils
Measured: 5 times in one month after ACL reconstruction
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.
Measured: 5 times in one month after ACL reconstruction
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.
Measured: 5 times in one month after ACL reconstruction
Oximetry
Oximetry determines changes in blood oxygen levels which fits over a fingertip.
Measured: 5 times in one month after ACL reconstruction
Snoring
Snoring and other noises. recorded with a sound probe over the neck.
Measured: 5 times in one month after ACL reconstruction
Secondary outcomes (4)
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.
Measured: 5 times in one month after ACL reconstruction
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
Measured: before and after five times in one month after ACL reconstruction, 6-month, 12-month follow-up
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.
Measured: 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)
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
Measured: before and after five times in one month after ACL reconstruction, 6-month, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start23 Apr 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament (Acl) ReconstructionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382324
- Sponsor's protocol ID
- 202301280B0
- Status last verified
- Mar 2026
- First submitted
- 1 Apr 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06382324
- Acronym / sponsor ID
- 202301280B0
- Keywords
- Mindfulness, Napping, ACL injury, Return-to-sport, Polysomnography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Apr 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention arem | Experimental | Behavioral: mindfulness practice of body scanThe patient randomized in the intervention arm will listen to the records of body scan for 40 minutes with polysomnography evaluation |
| control arm | Placebo comparator | Behavioral: listening to light musiclistening to light music for 40 minutes with polysomnography evaluation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Within the first month after ACL reconstruction without mindfulness practice experience
Key exclusion criteria (1 listed)
- below 18 years old, previous exposure to mindfulness intervention
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 |
|---|---|---|
| mindfulness practice of body scanMindfulness 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. | Behavioural | intervention arem |
| listening to light musiclistening to light music asa control | Behavioural | control arm |
Primary outcome
Electroencephalogram (EEG)
Time frame: 5 times in one month after ACL reconstruction
Electroencephalogram (EEG) is used to monitors patient's brain activities
Electrooculography (EOG)
Time frame: 5 times in one month after ACL reconstruction
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.
Electromyography (EMG)
Time frame: 5 times in one month after ACL reconstruction
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.
ECG (Electrocardiography)
Time frame: 5 times in one month after ACL reconstruction
ECG (Electrocardiography) measure the electrical activity of the heart.
Nasal/Oral airflow
Time frame: 5 times in one month after ACL reconstruction
Nasal/Oral airflow measured using pressure transducers, and/or a thermocouple, fitted in or near the nostrils
Thermistor
Time frame: 5 times in one month after ACL reconstruction
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.
Chest and abdominal belt
Time frame: 5 times in one month after ACL reconstruction
Chest and abdominal belt measured in concert with nasal/oral airflow by the use of belts. These belts expand and contract upon breathing effort.
Oximetry
Time frame: 5 times in one month after ACL reconstruction
Oximetry determines changes in blood oxygen levels which fits over a fingertip.
Snoring
Time frame: 5 times in one month after ACL reconstruction
Snoring and other noises. recorded with a sound probe over the neck.
4 secondary outcomes
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
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 31 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness practice of body scan and listening to light music in people with Anterior Cruciate Ligament (Acl) Reconstruction, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 31 Jul 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Contact Jain-Hong Chen (096-130-7506, psydr.jc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalogram (EEG) (time frame: 5 times in one month after ACL reconstruction). The study lists 9 primary outcomes in all. 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 31 Jul 2026.