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Healthy Volunteers - Male and FemaleBBAT-EEGNCT07736365

Acute Effects of a Single-Session Body Awareness Intervention on Cortical Activity and Interoceptive Accuracy

A study testing Basic Body Awareness Therapy Intervention in people with Healthy Volunteers - Male and Female, run by Ertugrul Deniz Kose.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial summary

This study will examine the immediate (acute) effects of a single, 30-minute body awareness session on brain activity and interoceptive accuracy in healthy young adults aged 18-25. Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers - Male and Female
What is being tested?
Basic Body Awareness Therapy Intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 31 Mar 2028
Phase
Interventional

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

  • Age 18-25 years
  • Self-reported healthy status
  • Literate in Turkish
  • Willing and able to provide written informed consent

Who cannot join

  • Active epilepsy or seizure history
  • Diagnosed psychiatric disorder
  • Neurological disorder
  • Cardiac arrhythmia, pacemaker, heart disease
  • Active use of psychotropic, beta-blocker, anticholinergic, or antihistamine medication
  • Prior participation in Basic Body Awareness Therapy
Show all 12Show fewer
  • Pregnancy
  • Active scalp lesion or dermatological pathology
  • Neurological/psychiatric medication affecting alertness or attention
  • Alcohol consumption in the last 24 hours
  • Excessive caffeine intake on the day of measurement
  • Acute pain, fever, infection, or other condition that could affect measurement

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ertuğrul Deniz Köse, Ph.D contact

+905056740998

ertugrul.kose@amasya.edu.tr

Eylem KÜÇÜK, Ph.D contact

+905067025859

eylem.kucuk@amasya.edu.tr

About this study

Official title: Investigation of the Acute Effects of a Body Awareness Application on Cortical Activity and Interoceptive Accuracy in Healthy Young Adults

This study will examine the immediate (acute) effects of a single, 30-minute body awareness session on brain activity and interoceptive accuracy in healthy young adults aged 18-25. Participants will be randomly assigned to one of two groups: an intervention group, which will complete a structured body awareness exercise based on Basic Body Awareness Therapy, or a control group, which will rest quietly for the same amount of time without any specific instructions.

Before and after the session, brain activity will be recorded using a portable, 8-channel EEG device, and interoceptive accuracy will be measured with a heartbeat perception task, in which participants try to count their own heartbeats without checking their pulse. The main goal is to determine whether a single body awareness session produces measurable changes in EEG brain wave patterns (theta, alpha, beta, and gamma bands) and in the accuracy of heartbeat perception, and whether these two types of change are related to each other.

Read the detailed description

Body awareness is a multidimensional construct that involves conscious perception of posture, breathing, muscle tone, movement, balance, contact, and internal bodily sensations. It is closely related to interoception - the perception and interpretation of physiological signals arising from within the body. Prior research suggests that body-awareness-based approaches, such as Basic Body Awareness Therapy, can positively influence body awareness, body attitude, and psychophysiological function in various clinical populations. However, few studies have examined the acute neurophysiological effects of a single body awareness session in healthy young adults using portable, low-channel EEG systems, and the relationship between EEG changes and interoceptive accuracy remains insufficiently explored.

This study is designed as a two-arm, parallel-group, randomized controlled trial. Participants will be randomly assigned in a 1:1 ratio to either an intervention group or a control group. Randomization will be generated by an independent researcher not involved in data collection or intervention delivery, using a computer-based random number method; group allocation will be concealed using sequentially numbered, opaque, sealed envelopes opened only after baseline measurements are completed. Due to the nature of the intervention, participants and the person delivering the session cannot be blinded; however, researchers involved in EEG signal processing and interoceptive accuracy scoring will be blinded to group assignment where possible.

The intervention group will receive a single, approximately 30-minute structured body awareness session based on Basic Body Awareness Therapy principles, consisting of preparatory orientation, supine body scanning and contact awareness, breath awareness, slow symmetrical movement awareness, seated midline/postural awareness, standing weight-shift awareness, and a closing integration period. The control group will undergo a quiet/neutral resting session of equal duration and in the same environment, without any body-awareness-related instructions, in order to control for effects attributable to time, environment, rest, or eye closure alone.

In both groups, resting-state EEG will be recorded before and after the session using an 8-channel wireless EEG device (Enobio 8) at a 500 Hz sampling rate, following the international 10-20 system, with electrode sites covering frontal, sensorimotor, and parietal regions (Fz, FCz, Cz, C3, C4, Pz, P3, P4). EEG data will be preprocessed using standard steps including band-pass filtering (1-45 Hz), 50 Hz notch filtering, independent component analysis (ICA), artifact rejection, and common average referencing. Absolute and relative power in the delta, theta, alpha, beta, and gamma frequency bands will be calculated, with particular attention to frontal theta, alpha, and gamma activity, given their proposed associations with attention, internal focus, and relaxation.

Interoceptive accuracy will be assessed before and after the session using a heartbeat perception task based on the Schandry method, in which participants silently count perceived heartbeats over defined time intervals without taking their pulse; actual heartbeats will be recorded physiologically over the same intervals, and a normalized interoceptive accuracy score will be derived from the agreement between perceived and actual counts.

The primary outcome is the pre-to-post change in EEG frequency band power. The secondary outcome is the pre-to-post change in interoceptive accuracy score, and the relationship between EEG-based changes and interoceptive accuracy changes will also be examined. Sample size was determined via power analysis (G*Power 3), based on effect sizes reported in prior heartbeat-evoked potential research, yielding a target of 42 participants per group (84 total) at α = 0.05 and 80% power, including an allowance for a 20% dropout rate. Statistical analysis will include mixed-design analyses (e.g., two-way mixed ANOVA or linear mixed models) to evaluate group × time interactions for EEG outcomes, and correlational analyses (Pearson or Spearman) to examine associations between EEG and interoceptive accuracy changes, with appropriate corrections for multiple comparisons across channels and frequency bands. The study will be conducted and reported in accordance with CONSORT guidelines for randomized controlled trials.

Being tested
Basic Body Awareness Therapy Intervention, No Intervention/Sham Comparator
Keywords
body awareness, basic body awareness therapy, interoception, EEG, cortical activity, heartbeat perception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Basic Body Awareness Therapy InterventionOther

    A single ~30-minute body awareness session delivered in a quiet, well-ventilated room with minimal distraction. The session follows a structured sequence of low-intensity, pain-free, non-strenuous body awareness exercises performed in supine, sitting, and standing positions, guided verbally by a trained physiotherapist or researcher. The session focuses on conscious awareness of posture, contact points, breathing, and movement quality rather than physical performance, strength, or flexibility. Participants are instructed to move without forcing and to report any pain, dizziness, or discomfort during the session.

  • No Intervention/Sham ComparatorOther

    A single ~30-minute quiet resting session delivered in the same room and under the same environmental conditions as the intervention session. Participants will be asked to remain in a comfortable seated or supine position, close their eyes or fix their gaze on a stationary point, and rest quietly for the full duration. No specific breathing, body awareness, or movement instructions will be given. Participants will be informed that they may notify the researcher if they experience any discomfort.

Study groups in NCT07736365
Study groupRoleWhat they receive
Basic Body Awareness Therapy Intervention GroupExperimentalParticipants in this arm will receive a single, approximately 30-minute structured session based on Basic Body Awareness Therapy principles, guided by a physiotherapist or researcher trained in body awareness applications. The session includes preparatory orientation, supine body scanning and contact awareness, breath awareness, slow symmetrical movement awareness, seated midline and postural awareness, standing weight-shift awareness, and a closing integration period.
Receives: Other: Basic Body Awareness Therapy Intervention
No Intervention/Sham Comparator: Control (Quiet Rest)Sham comparatorParticipants in this arm will undergo a quiet/neutral resting session of the same duration and in the same environment as the intervention group, without receiving any body-awareness-related instructions, guidance, breathing exercises, or movement tasks. This arm serves to control for effects attributable to time, environment, rest, or eye closure alone.
Receives: Other: No Intervention/Sham Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in EEG Theta Band Power

    Absolute power (µV²) in the theta frequency band (4-8 Hz), calculated from EEG recordings before and after the body awareness intervention.

    Measured: Immediately before vs. immediately after the ~30-minute session

  2. Change in EEG Alpha Band Power

    Absolute power (µV²) in the alpha frequency band (8-13 Hz), calculated from EEG recordings before and after the body awareness intervention.

    Measured: Immediately before vs. immediately after the ~30-minute session

  3. Change in EEG Beta Band Power

    Absolute power (µV²) in the beta frequency band (13-30 Hz), calculated from EEG recordings before and after the body awareness intervention.

    Measured: Immediately before vs. immediately after the ~30-minute session

  4. Change in EEG Gamma Band Power

    Absolute power (µV²) in the gamma frequency band (30-45 Hz), calculated from EEG recordings before and after the body awareness intervention.

    Measured: Immediately before vs. immediately after the ~30-minute session

Secondary outcomes (1)
  1. Change in interoceptive accuracy score

    Interoceptive accuracy will be measured using a normalized accuracy score derived from the Schandry heartbeat perception task, ranging from 0 to 1, where higher scores indicate greater accuracy in perceiving one's own heartbeat (i.e., better interoceptive accuracy).

    Measured: Immediately before vs. immediately after the ~30-minute session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: an intervention group receiving a single structured body awareness session, or a control group receiving a quiet/neutral resting session of equal duration. Both groups will undergo identical pre- and post-session EEG recordings and interoceptive accuracy assessments, allowing within-group (pre-post) and between-group comparisons of change.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07736365
Sponsor's protocol ID
Amasya Uni-BBAT
Acronym
BBAT-EEG
Status last verified
Jul 2026
First submitted
17 Jul 2026
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. In accordance with the study's ethical protocol, personal identifying information will be kept separate from the analysis dataset, and EEG recordings, interoceptive accuracy scores, and questionnaire responses will be stored in encrypted digital form accessible only to the research team. Study findings will be reported in aggregate form in scientific publications, without disclosing any individual participant's identity or raw data.

Publications

  • Bravo C, Skjaerven LH, Espart A, Guitard Sein-Echaluce L, Catalan-Matamoros D. Basic Body Awareness Therapy in patients suffering from fibromyalgia: A randomized clinical trial. Physiother Theory Pract. 2019 Oct;35(10):919-929. doi: 10.1080/09593985.2018.1467520. Epub 2018 May 3.

    PubMed 29723080
  • Lundvik Gyllensten, A., Hansson, L., & Ekdahl, C. (2003). Outcome of Basic Body Awareness Therapy. A randomized controlled study of patients in psychiatric outpatient care. Advances in Physiotherapy, 5(4), 179-190. https://doi.org/10.1080/14038109310012061

  • Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

    PubMed 20332509
  • Schandry R. Heart beat perception and emotional experience. Psychophysiology. 1981 Jul;18(4):483-8. doi: 10.1111/j.1469-8986.1981.tb02486.x. No abstract available.

    PubMed 7267933
  • Petzschner FH, Weber LA, Wellstein KV, Paolini G, Do CT, Stephan KE. Focus of attention modulates the heartbeat evoked potential. Neuroimage. 2019 Feb 1;186:595-606. doi: 10.1016/j.neuroimage.2018.11.037. Epub 2018 Nov 22.

    PubMed 30472370
  • Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.

    PubMed 23133619
  • Lutz A, Slagter HA, Dunne JD, Davidson RJ. Attention regulation and monitoring in meditation. Trends Cogn Sci. 2008 Apr;12(4):163-9. doi: 10.1016/j.tics.2008.01.005. Epub 2008 Mar 10.

    PubMed 18329323
  • Lomas T, Ivtzan I, Fu CH. A systematic review of the neurophysiology of mindfulness on EEG oscillations. Neurosci Biobehav Rev. 2015 Oct;57:401-10. doi: 10.1016/j.neubiorev.2015.09.018. Epub 2015 Oct 9.

    PubMed 26441373
  • Garfinkel SN, Seth AK, Barrett AB, Suzuki K, Critchley HD. Knowing your own heart: distinguishing interoceptive accuracy from interoceptive awareness. Biol Psychol. 2015 Jan;104:65-74. doi: 10.1016/j.biopsycho.2014.11.004. Epub 2014 Nov 20.

    PubMed 25451381
  • Farb N, Daubenmier J, Price CJ, Gard T, Kerr C, Dunn BD, Klein AC, Paulus MP, Mehling WE. Interoception, contemplative practice, and health. Front Psychol. 2015 Jun 9;6:763. doi: 10.3389/fpsyg.2015.00763. eCollection 2015.

    PubMed 26106345
  • Coll MP, Hobson H, Bird G, Murphy J. Systematic review and meta-analysis of the relationship between the heartbeat-evoked potential and interoception. Neurosci Biobehav Rev. 2021 Mar;122:190-200. doi: 10.1016/j.neubiorev.2020.12.012. Epub 2021 Jan 13.

    PubMed 33450331
  • Cahn BR, Polich J. Meditation states and traits: EEG, ERP, and neuroimaging studies. Psychol Bull. 2006 Mar;132(2):180-211. doi: 10.1037/0033-2909.132.2.180.

    PubMed 16536641

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