Kinesiophobia (Fear of Movement)ANS MSK HRVNCT07370636
Binaural Beats Stimulation on the Autonomic Nervous System (ANS), Kinesiophobia and Fitness Levels in Professional Athletes With Musculoskeletal (MSK) Injuries
A study testing Auditory stimulation with binaural beats and guidance, Auditory stimulation without binaural beats and Auditory stimulation with background music in people with Kinesiophobia (Fear of Movement) and Musculoskeletal Injuries, run by University of West Attica.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Kinesiophobia (Fear of Movement), Musculoskeletal Injuries
- What is being tested?
- Auditory stimulation with binaural beats and guidance, Auditory stimulation without binaural beats and Auditory stimulation with background music
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Maria Papandreou, Professor contact
About this study
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
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.
Read more
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.
- Being tested
- Auditory stimulation with binaural beats and guidance, Auditory stimulation without binaural beats, Auditory stimulation with background music, Auditory stimulation general characteristics
- Keywords
- Binaural beats, kinesiophobia, Autonomic nervous system, sympathetic skin response, VO2max, Heart rate variability, grip strength test, pain, anxiety
- Medical subject headings
- Kinesiophobia, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory stimulation with binaural beats and guidanceDevice
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 beatsDevice
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 musicDevice
Auditory stimulation will be delivered exclusively via background music, without the incorporation of binaural beats or guided verbal instructions.
Auditory stimulation general characteristicsOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Binaural beats and guidance | Experimental | 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 Receives: Device: Auditory stimulation with binaural beats and guidance; Other: Auditory stimulation general characteristics |
| No binaural beat but guidance | Placebo comparator | 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. Receives: Device: Auditory stimulation without binaural beats; Other: Auditory stimulation general characteristics |
| No binaural beat, no guidance | Other | 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. Receives: Device: Auditory stimulation with background music; Other: Auditory stimulation general characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Kinesiophobia (Fear of Movement)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Collaborators
- Attikon Hospital
- Responsible party
- Principal investigator, Evangelos Kontogiannis, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370636
- Sponsor's protocol ID
- 62664/07-07-2025
- Acronym
- ANS MSK HRV
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 37205669Delleli 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.
PubMed 38078229Cici 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.
PubMed 36515211Chee 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.
PubMed 38458383Ballmann 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.
PubMed 33917781Bordeleau 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.
PubMed 36204486Wahbeh 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.
PubMed 17309374Ambegaonkar 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.
PubMed 38651436Franco-Alvarenga, P., Brietzke, C., Canestri, R., & Pires, F. (2019). Psychological responses of music on physical performance: A critical review. Revista Brasileira de Ciência e Movimento, 2019;27(2):218-224.
Fukumoto Y, Tsuji Y, Kakuda A, Hori R, Kitano M, Sakamoto K, Kudo S. Evaluation of autonomic nervous system responses during isometric handgrip exercise using nonlinear analysis of heart rate variability. J Phys Ther Sci. 2022 Oct;34(10):689-693. doi: 10.1589/jpts.34.689. Epub 2022 Oct 1.
PubMed 36213191
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07370636
- Acronym / sponsor ID
- ANS MSK HRV / 62664/07-07-2025
- Keywords
- Binaural beats, kinesiophobia, Autonomic nervous system, sympathetic skin response, VO2max, Heart rate variability, grip strength test, pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Collaborators
- Attikon Hospital
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Binaural beats and guidance | Experimental | Device: Auditory stimulation with binaural beats and guidance, Other: Auditory stimulation general characteristicsThe 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 |
| No binaural beat but guidance | Placebo comparator | Device: Auditory stimulation without binaural beats, Other: Auditory stimulation general characteristicsThe 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. |
| No binaural beat, no guidance | Other | Device: Auditory stimulation with background music, Other: Auditory stimulation general characteristicsParticipants 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory stimulation with binaural beats and guidanceThe 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 | Binaural beats and guidance |
| Auditory stimulation without binaural beatsThe 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 | No binaural beat but guidance |
| Auditory stimulation with background musicAuditory stimulation will be delivered exclusively via background music, without the incorporation of binaural beats or guided verbal instructions. | Device | No binaural beat, no guidance |
| 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 post the music intervention for all participants. | Other | Binaural beats and guidance, No binaural beat but guidance, No binaural beat, no guidance |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 37205669Ingendoh 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.
- Background: PubMed 38078229Delleli 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.
- Background: PubMed 36515211Cici 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.
- Background: PubMed 38458383Chee 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.
- Background: PubMed 33917781Ballmann 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.
- Background: PubMed 36204486Bordeleau 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.
- Background: PubMed 17309374Wahbeh 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.
- Background: PubMed 38651436Ambegaonkar 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.
- BackgroundFranco-Alvarenga, P., Brietzke, C., Canestri, R., & Pires, F. (2019). Psychological responses of music on physical performance: A critical review. Revista Brasileira de Ciência e Movimento, 2019;27(2):218-224.
- Background: PubMed 36213191Fukumoto Y, Tsuji Y, Kakuda A, Hori R, Kitano M, Sakamoto K, Kudo S. Evaluation of autonomic nervous system responses during isometric handgrip exercise using nonlinear analysis of heart rate variability. J Phys Ther Sci. 2022 Oct;34(10):689-693. doi: 10.1589/jpts.34.689. Epub 2022 Oct 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Papandreou, Professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Auditory stimulation with binaural beats and guidance, Auditory stimulation without binaural beats and Auditory stimulation with background music in people with Kinesiophobia (Fear of Movement) and Musculoskeletal Injuries, run by University of West Attica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evangelos Kontogiannis, PhD candidate (+306938180936, ekontogiannis@uniwa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sympathetic Skin Response (time frame: Changes from baseline up to 4 weeks; changes from baseline up to 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07370636, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.