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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Sympathetic Skin Response [Срок оценки: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks]
• Tampa Scale of Kinesiophobia (TSK-17) [Срок оценки: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks]
• Aerobic capacity [Срок оценки: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.]
• Heart Rate Variability (HRV) [Срок оценки: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.]

Вторичные конечные точки (4)

• Sport competition anxiety [Срок оценки: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.]
• Pain Beliefs and Perceptions Inventory [Срок оценки: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.]
• Hand Grip Strength Test [Срок оценки: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.]
• Blood lactate concentration [Срок оценки: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT07370636 · 62664/07-07-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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