Binaural Beats Stimulation on the Autonomic Nervous System (ANS), Kinesiophobia and Fitness Level… (NCT07370636) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Binaural Beats Stimulation on the Autonomic Nervous System (ANS), Kinesiophobia and Fitness Levels in Professional Athletes With Musculoskeletal (MSK) Injuries
66 participantsStarted 2026-02
Plain-language summary
The purpose of the current study is to investigate the effectiveness of binaural beat stimulation on the autonomic nervous system (ANS), taking into account kinesiophobia related to reinjury and fitness levels in professional athletes with musculoskeletal injuries. The study hypothesis is that binaural beats will have beneficial effects by reducing ANS activity, primarily through modulation of parasympathetic nervous system (PNS) activity, as well as by reducing kinesiophobia related to reinjury and enhancing fitness levels in this population.
Researchers will compare binaural beat stimulation to a placebo condition and to a condition without binaural beats in order to evaluate and compare the effects of those three conditions on psychological and physiological parameters in professional athletes with musculoskeletal injuries.
Participants will:
* Receive receive music intervention either with binaural beat stimulation or placebo or music without binaural beats before their training sessions and competitions for a period of four weeks.
* Maintain a diary to document each session of the music-based intervention.
Who can participate
Age range
18 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Professional athletes in open-skill sports
* Age 18-25 years old
* Participation in national and/or international professional championships for ≥ 5 years
* Athletes with previous lower limb musculoskeletal injuries within the past three months or longer
* Athletes with previous lower limb musculoskeletal injuries who have been fully rehabilitated.
* Injuries sustained during any training period or competitive event
* Provoke injuries during any training period or competitive event
* Athletes with Kinesiophobia who have presented Tampa of Scale Kinesiophobia (TSK) questionnaire scores ranging from 17 to 37
* Athletes with Anxiety who have presented Sport Competition Anxiety Test (SCAT) questionnaire scores more than 17
* Frequency of engaging in sports 3-5 times per week (training, competitions)
* Duration of each training session not exceeding 90 minutes
* Athletes with adequate proficiency in the English language
Exclusion Criteria:
* Amateur and recreational athletes in open-skill activities
* Athletes ≤ 17 and ≥ 26 years old
* Athletes in close-skill sports
* Athletes with current musculoskeletal injuries (\< 3 months)
* Athletes with poor rehabilitation of sport injuries
* Athletes with musculoskeletal injuries of upper limbs and trunk
* Athletes with musculoskeletal injuries during off-season periods
* Athletes with recent surgery
* Athletes with a concussion that occurred during training or competition
* Athletes with psychological and neurolog…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sympathetic Skin Response
Timeframe: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks
2
Tampa Scale of Kinesiophobia (TSK-17)
Timeframe: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks
3
Aerobic capacity
Timeframe: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.
4
Heart Rate Variability (HRV)
Timeframe: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.