The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction

NCT ID: NCT06382324

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-23

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Cruciate Ligament (Acl) Reconstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessor of polysomnography did not know the data belongs which group

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention arem

The patient randomized in the intervention arm will listen to the records of body scan for 40 minutes with polysomnography evaluation

Group Type EXPERIMENTAL

mindfulness practice of body scan

Intervention Type BEHAVIORAL

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.

control arm

listening to light music for 40 minutes with polysomnography evaluation

Group Type PLACEBO_COMPARATOR

listening to light music

Intervention Type BEHAVIORAL

listening to light music asa control

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

listening to light music

listening to light music asa control

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* below 18 years old, previous exposure to mindfulness intervention
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ChangGungMH

Keelung, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jain-Hong Chen

Role: CONTACT

096-130-7506

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jian-Hong Chen

Role: primary

096-130-7506

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202301280B0

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.