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.
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
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- 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.
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.
- Conditions
- Healthy Volunteers - Male and Female
- 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 group | Role | What they receive |
|---|---|---|
| Basic Body Awareness Therapy Intervention Group | Experimental | Participants 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 comparator | Participants 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.
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
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
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
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)
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.
- First posted30 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers - Male and FemaleStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Ertugrul Deniz Kose
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ertugrul Deniz Kose, Hitit University
- Investigators
- Ertuğrul Deniz Köse, Ph.D, Principal investigator, Amasya University
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 29723080Lundvik 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 20332509Schandry 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 7267933Petzschner 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 30472370Mehling 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 23133619Lutz 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 18329323Lomas 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 26441373Garfinkel 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 25451381Farb 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 26106345Coll 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 33450331Cahn 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