An interventional study of Auditory stimulation with binaural beats and guidance and Auditory stimulation without binaural beats in Kinesiophobia (Fear of Movement) and Musculoskeletal Injuries, sponsored by University of West Attica. Not yet recruiting. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by University of West Attica · Not applicable, Interventional, and Treatment
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:
285 studies on the registry are indexed under Kinesiophobia; 91 are open to participants now.
This study's planned enrollment of 66 is above the median of 52 across 174 interventional studies indexed under Kinesiophobia.
Browse Kinesiophobia studies →University of West Attica is the lead sponsor of 31 studies on the registry; 13 are open to participants now.
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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
Device: Auditory stimulation with binaural beats and guidance · Other: Auditory stimulation general characteristics
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.
Device: Auditory stimulation without binaural beats · Other: Auditory stimulation general characteristics
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.
Device: Auditory stimulation with background music · Other: Auditory stimulation general characteristics
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.
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 will be delivered exclusively via background music, without the incorporation of binaural beats or guided verbal instructions.
* 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.
Sympathetic Skin Response
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.
Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks
Tampa Scale of Kinesiophobia (TSK-17)
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.
Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks
Aerobic capacity
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.
Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.
Heart Rate Variability (HRV)
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.
Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.
Sport competition anxiety
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.
Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.
Pain Beliefs and Perceptions Inventory
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.
Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.
Hand Grip Strength Test
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.
Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.
Blood lactate concentration
Blood lactate concentration will be measured before the incremental exercise test and at the end of the test.
Time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.
No study locations are listed for this record.
Start is estimated for Feb 2026; primary completion for Jun 2027, 16 months later.
Of 132 non-industry interventional studies with no phase under Kinesiophobia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's planned 16 months is above that.
Counting every sponsor, half of 132 studies reached it within 8 months; a quarter within 4 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
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University of West Attica