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NCT Number: NCT07370636

Binaural Beats Stimulation on the Autonomic Nervous System (ANS), Kinesiophobia and Fitness Levels in Professional Athletes With Musculoskeletal (MSK) Injuries

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 neurological problems
  • Athletes with hearing impairment
  • Athletes with inadequate proficiency in the English language

Treatment and study plan

Auditory stimulation with binaural beats and guidance

Device

The music track will provide auditory stimulation using binaural beats at low beta frequencies (12-15 Hz) accompanied by guided instructions over a low-tempo musical background with a gradual increase in rhythm toward the end of the track.

Auditory stimulation without binaural beats

Device

The music track will provide auditory stimulation without the use binaural beats (12-15 Hz). It will consist solely of guided instructions delivered over a low-tempo musical background with a gradual increase in rhythm toward the end of the track.

Auditory stimulation with background music

Device

Auditory stimulation will be delivered exclusively via background music, without the incorporation of binaural beats or guided verbal instructions.

Auditory stimulation general characteristics

Other
  • Each participant will receive the music track during the pre-training/ pre- competition as a part of the warmup using audible manner
  • All music tracks will employ the same background music, standardized across sessions with identical characteristics, including tempo, frequency, and other acoustic parameters, to ensure consistency throughout the intervention.
  • Questionnaires are going to be used to evaluate kinesiophobia, sport anxiety, competitions and pain beliefs and perceptions pre and post the music intervention for all participants.

Primary outcomes

  1. Sympathetic Skin Response

    Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks

    Sympathetic Skin Response (SSR) test will be used to assess the changes of the Autonomic Nervous System (ANS). SSR will be assessed by calculating the latency and the amplitude. The Latency was measured from the onset of the stimulus artefact to the first deflection from baseline (in seconds) and amplitude was measured peak-to-peak (from negative to positive peak, in millivolts). The Sympathetic Skin Response will be carried out using Electromyography (EMG). Electrical stimuli were delivered to the right wrist at an intensity of 75 mA and a duration of 0.1 ms. The band-pass filter was set between 0.5 and 2000 Hz. Five stimuli were administered unpredictably at random intervals of at least 30 seconds. The shortest latency and the highest amplitude response values among the five responses were used for statistical analysis. Parameters included in the analysis were: SSR upper limb latency, SSR upper limb amplitude, SSR lower limb latency, and SSR lower limb amplitude.

  2. Tampa Scale of Kinesiophobia (TSK-17)

    Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks

    Tampa Scale of Kinesiophobia questionnaire (TSK-17) will be used translated to Greek. It has been tested for its reliability and validity. Scale from 17 to 68. 17 means the person experiences low level of kinesiophobia and 68 means the person experiences high level of kinesiophobia.

  3. Aerobic capacity

    Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.

    An incremental exercise test will be used to assess the aerobic capacity. This method is commonly used to evaluate maximal oxygen uptake (VO₂max) and involves a protocol of progressively increasing exercise intensity until volitional exhaustion. Participants will run on a motorized treadmill set at a constant incline of 0%. Running speed will begin at approximately 8-9 km/h and will increase by 1 km/h at the end of each 1-minute stage. Respiratory variables will be continuously measured on a breath-by-breath basis using a gas analysis system. The test will be terminated when participants reach volitional exhaustion, when oxygen uptake values plateau or decrease despite further increases in workload and ventilation or when the respiratory exchange ratio exceeds 1.10. Total test duration is expected to be approximately 8-12 minutes.

  4. Heart Rate Variability (HRV)

    Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.

    Heart Rate Variability (HRV) is a tool to assess the Autonomic Nervous System function. HRV will be recorded using a telemetric heart rate monitor (Polar H10). Recordings will be conducted in a quiet, calm room, with participants in the supine position. Participants will be instructed not to move, talk, and to breathe normally while remaining supine during the recording. All participants will perform an incremental exercise test on a treadmill at a constant 0% incline, with intensity gradually increasing every minute. Prior to the test, participants will lie supine for 5 minutes while resting HRV is recorded. Participants will then follow the exercise protocol and at the end of the exercise, they will be asked to remain supine for 15 minutes. The time required for HRV to return to each participant's resting level will be recorded. The test will be automatically terminated once participants reach 85% of their maximum heart rate (HRmax) or voluntarily.

Secondary outcomes

  1. Sport competition anxiety

    Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.

    Sport competition anxiety questionnaire (SCAT) will be used translated to Greek. It has been tested for its reliability and validity. Scale from 10 to 30. Scores under 17 show low level of competition anxiety. Scores over 24 show high level of competition anxiety.

  2. Pain Beliefs and Perceptions Inventory

    Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.

    Pain Beliefs and Perceptions Inventory questionnaire (PBPI-16) will be used translated to Greek. It has been tested for its reliability and validity. Scale from -32 to 32. -32 means the person does not express negative beliefs, 32 means the person expresses negative beliefs.

  3. Hand Grip Strength Test

    Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.

    The Hand Grip Strength Test will be used to assess grip strength through the performance of a maximal voluntary contraction. A portable Kinvent hand dynamometer will be used for the assessment. The test will be performed in a seated position with the shoulder in a neutral position, the elbow flexed at 90° without support, the forearm in a neutral position, and the wrist positioned between 0° and 30° of dorsiflexion and 0°-15° of ulnar deviation. Participants will perform three maximal efforts, each lasting 30 seconds, with a 1-minute rest period between attempts. The test will be conducted in the same manner for both upper limbs. For statistical analysis, the mean value of the three trials will be calculated separately for each upper limb.

  4. Blood lactate concentration

    Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.

    Blood lactate concentration will be measured before the incremental exercise test and at the end of the test.

Study contacts

Contact information is provided by the study sponsor or research team.

Evangelos Kontogiannis, PhD candidate

CONTACT

[email protected]

+306938180936

Maria Papandreou, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of West Attica

Other

Collaborators

  • Attikon Hospital

Registry information

Official study title

The Effect of Binaural Beats Stimulation on the Autonomic Nervous System, Considering Kinesiophobia of Reinjuries and Fitness Levels in Professional Athletes With Musculoskeletal Injuries

Acronym: ANS MSK HRV

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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