- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07736365
Acute Effects of a Single-Session Body Awareness Intervention on Cortical Activity and Interoceptive Accuracy (BBAT-EEG)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Eylem KÜÇÜK, Ph.D
- Telefonnummer: +905067025859
- E-mail: eylem.kucuk@amasya.edu.tr
Undersøgelse Kontakt Backup
- Navn: Ertuğrul Deniz Köse, Ph.D
- Telefonnummer: +905056740998
- E-mail: ertugrul.kose@amasya.edu.tr
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age 18-25 years
- Self-reported healthy status
- Literate in Turkish
- Willing and able to provide written informed consent
Exclusion Criteria:
- 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
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Basic Body Awareness Therapy Intervention Group
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.
|
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.
|
|
Sham-komparator: No Intervention/Sham Comparator: Control (Quiet Rest)
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.
|
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in EEG Theta Band Power
Tidsramme: Immediately before vs. immediately after the ~30-minute session
|
Absolute power (µV²) in the theta frequency band (4-8 Hz), calculated from EEG recordings before and after the body awareness intervention.
|
Immediately before vs. immediately after the ~30-minute session
|
|
Change in EEG Alpha Band Power
Tidsramme: Immediately before vs. immediately after the ~30-minute session
|
Absolute power (µV²) in the alpha frequency band (8-13 Hz), calculated from EEG recordings before and after the body awareness intervention.
|
Immediately before vs. immediately after the ~30-minute session
|
|
Change in EEG Beta Band Power
Tidsramme: Immediately before vs. immediately after the ~30-minute session
|
Absolute power (µV²) in the beta frequency band (13-30 Hz), calculated from EEG recordings before and after the body awareness intervention.
|
Immediately before vs. immediately after the ~30-minute session
|
|
Change in EEG Gamma Band Power
Tidsramme: Immediately before vs. immediately after the ~30-minute session
|
Absolute power (µV²) in the gamma frequency band (30-45 Hz), calculated from EEG recordings before and after the body awareness intervention.
|
Immediately before vs. immediately after the ~30-minute session
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in interoceptive accuracy score
Tidsramme: Immediately before vs. immediately after the ~30-minute session
|
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).
|
Immediately before vs. immediately after the ~30-minute session
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation Between Change in EEG Theta Band Power and Change in Interoceptive Accuracy Score
Tidsramme: Assessed using pre-post change scores from the same ~30-minute session
|
The relationship between the pre-post change in EEG theta band power (4-8 Hz, measured via 8-channel EEG) and the pre-post change in interoceptive accuracy score (measured via the Schandry heartbeat perception task) will be evaluated using Pearson or Spearman correlation coefficients, as appropriate to the data distribution.
|
Assessed using pre-post change scores from the same ~30-minute session
|
|
Correlation Between Change in EEG Alpha Band Power and Change in Interoceptive Accuracy Score
Tidsramme: Assessed using pre-post change scores from the same ~30-minute session
|
The relationship between the pre-post change in EEG alpha band power (8-13 Hz, measured via 8-channel EEG) and the pre-post change in interoceptive accuracy score (measured via the Schandry heartbeat perception task) will be evaluated using Pearson or Spearman correlation coefficients, as appropriate to the data distribution.
|
Assessed using pre-post change scores from the same ~30-minute session
|
|
Correlation Between Change in EEG Beta Band Power and Change in Interoceptive Accuracy Score
Tidsramme: Assessed using pre-post change scores from the same ~30-minute session
|
The relationship between the pre-post change in EEG beta band power (13-30 Hz, measured via 8-channel EEG) and the pre-post change in interoceptive accuracy score (measured via the Schandry heartbeat perception task) will be evaluated using Pearson or Spearman correlation coefficients, as appropriate to the data distribution.
|
Assessed using pre-post change scores from the same ~30-minute session
|
|
Correlation Between Change in EEG Gamma Band Power and Change in Interoceptive Accuracy Score
Tidsramme: Assessed using pre-post change scores from the same ~30-minute session
|
The relationship between the pre-post change in EEG gamma band power (30-45 Hz, measured via 8-channel EEG) and the pre-post change in interoceptive accuracy score (measured via the Schandry heartbeat perception task) will be evaluated using Pearson or Spearman correlation coefficients, as appropriate to the data distribution.
|
Assessed using pre-post change scores from the same ~30-minute session
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ertuğrul Deniz Köse, Ph.D, Amasya University
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Amasya Uni-BBAT
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