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Not yet recruiting NCT07370636

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

No phase Interventional Kinesiophobia (Fear of Movement) Musculoskeletal Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Auditory stimulation with binaural beats and guidance, Auditory stimulation without binaural beats, Auditory stimulation with background music, Auditory stimulation general characteristics.
Who it may be relevant to
Registry conditions: Kinesiophobia (Fear of Movement), Musculoskeletal Injuries. Basic parameters: 18 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Device Auditory stimulation with binaural beats and guidance
    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.
  • Device Auditory stimulation without binaural beats
    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.
  • Device Auditory stimulation with background music
    Auditory stimulation will be delivered exclusively via background music, without the incorporation of binaural beats or guided verbal instructions.
  • Other Auditory stimulation general characteristics
    * 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 po

Primary outcome measures

  • Sympathetic Skin Response [Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks]
  • Tampa Scale of Kinesiophobia (TSK-17) [Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks]
  • Aerobic capacity [Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.]
  • Heart Rate Variability (HRV) [Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.]
Secondary outcome measures (4)
  • Sport competition anxiety [Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.]
  • Pain Beliefs and Perceptions Inventory [Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.]
  • Hand Grip Strength Test [Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.]
  • Blood lactate concentration [Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Ingendoh RM, Posny ES, Heine A. Binaural beats to entrain the brain? A systematic review of the effects of binaural beat stimulation on brain oscillatory activity, and the implications for psychological research and intervention. PLoS One. 2023 May 19;18(5):e0286023. doi: 10.1371/journal.pone.0286023. eCollection 2023. PMID 37205669
  • Delleli S, Ouergui I, Ballmann CG, Messaoudi H, Trabelsi K, Ardigo LP, Chtourou H. The effects of pre-task music on exercise performance and associated psycho-physiological responses: a systematic review with multilevel meta-analysis of controlled studies. Front Psychol. 2023 Nov 23;14:1293783. doi: 10.3389/fpsyg.2023.1293783. eCollection 2023. PMID 38078229
  • Cici R, Bulbuloglu S, Kapikiran G. Effect of meditation music and comedy movie interventions on postoperative kinesiophobia and pain in patients undergoing total knee arthroplasty. ANZ J Surg. 2023 Jan;93(1-2):302-309. doi: 10.1111/ans.18209. Epub 2022 Dec 14. PMID 36515211
  • Chee ZJ, Chang CYM, Cheong JY, Malek FHBA, Hussain S, de Vries M, Bellato A. The effects of music and auditory stimulation on autonomic arousal, cognition and attention: A systematic review. Int J Psychophysiol. 2024 May;199:112328. doi: 10.1016/j.ijpsycho.2024.112328. Epub 2024 Mar 6. PMID 38458383
  • Ballmann CG. The Influence of Music Preference on Exercise Responses and Performance: A Review. J Funct Morphol Kinesiol. 2021 Apr 8;6(2):33. doi: 10.3390/jfmk6020033. PMID 33917781
  • Bordeleau M, Vincenot M, Lefevre S, Duport A, Seggio L, Breton T, Lelard T, Serra E, Roussel N, Neves JFD, Leonard G. Treatments for kinesiophobia in people with chronic pain: A scoping review. Front Behav Neurosci. 2022 Sep 20;16:933483. doi: 10.3389/fnbeh.2022.933483. eCollection 2022. PMID 36204486
  • Wahbeh H, Calabrese C, Zwickey H. Binaural beat technology in humans: a pilot study to assess psychologic and physiologic effects. J Altern Complement Med. 2007 Jan-Feb;13(1):25-32. doi: 10.1089/acm.2006.6196. PMID 17309374
  • Ambegaonkar JP, Jordan M, Wiese KR, Caswell SV. Kinesiophobia in Injured Athletes: A Systematic Review. J Funct Morphol Kinesiol. 2024 Apr 19;9(2):78. doi: 10.3390/jfmk9020078. PMID 38651436

Identifiers

NCT: NCT07370636 · 62664/07-07-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗