The Effect of Binaural Beats Stimulation on the Autonomic Nervous System, Considering Kinesiophobia of Reinjuries and Fitness Levels in Professional Athletes With Musculoskeletal Injuries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of West Attica
- Enrollment
- 66
- Primary Endpoint
- Sympathetic Skin Response
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Binaural beats and guidance
The experimental group will participate in a music-based program designed to improve attention, mental alertness, readiness for action and to reduce kinesiophobia. The music track that will be used for this group of participants will include binaural beats and guidance. Participants will receive the music program for 4 weeks / 5 sessions per week, for a total of 20 sessions of 15 minutes each
Intervention: Auditory stimulation with binaural beats and guidance (Device)
Binaural beats and guidance
The experimental group will participate in a music-based program designed to improve attention, mental alertness, readiness for action and to reduce kinesiophobia. The music track that will be used for this group of participants will include binaural beats and guidance. Participants will receive the music program for 4 weeks / 5 sessions per week, for a total of 20 sessions of 15 minutes each
Intervention: Auditory stimulation general characteristics (Other)
No binaural beat but guidance
The Placebo group will participate in a music-based program designed to improve attention, mental alertness, readiness for action and to reduce kinesiophobia. The music track provided to this group will be the same as in the other two groups but it will only include guidance and not binaural beats. Participants will receive the music program for 4 weeks / 5 sessions per week, for a total of 20 sessions of 15 minutes each.
Intervention: Auditory stimulation without binaural beats (Device)
No binaural beat but guidance
The Placebo group will participate in a music-based program designed to improve attention, mental alertness, readiness for action and to reduce kinesiophobia. The music track provided to this group will be the same as in the other two groups but it will only include guidance and not binaural beats. Participants will receive the music program for 4 weeks / 5 sessions per week, for a total of 20 sessions of 15 minutes each.
Intervention: Auditory stimulation general characteristics (Other)
No binaural beat, no guidance
Participants allocated to the control group will undergo a structured music-based intervention designed to enhance attentional focus, mental alertness, and action readiness, while concurrently aiming to reduce kinesiophobia. The music track used for this group will be the same as in the other two groups but it will include neither binaural beats nor guidance. The intervention will be administered for 4 weeks / 5 sessions per week, for a total of 20 sessions of 15 minutes each.
Intervention: Auditory stimulation with background music (Device)
No binaural beat, no guidance
Participants allocated to the control group will undergo a structured music-based intervention designed to enhance attentional focus, mental alertness, and action readiness, while concurrently aiming to reduce kinesiophobia. The music track used for this group will be the same as in the other two groups but it will include neither binaural beats nor guidance. The intervention will be administered for 4 weeks / 5 sessions per week, for a total of 20 sessions of 15 minutes each.
Intervention: Auditory stimulation general characteristics (Other)
Outcomes
Primary Outcomes
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.
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.
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.
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
- Sport competition anxiety(Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.)
- Pain Beliefs and Perceptions Inventory(Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.)
- Hand Grip Strength Test(Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.)
- Blood lactate concentration(Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.)
Investigators
Evangelos Kontogiannis
Physiotherapist, PhD candidate
University of West Attica