NCT07736365

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

July 17, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

body awarenessbasic body awareness therapyinteroceptionEEGcortical activityheartbeat perception

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

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

Secondary Outcomes (1)

  • Change in interoceptive accuracy score

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

Other Outcomes (4)

  • Correlation Between Change in EEG Theta Band Power and Change in Interoceptive Accuracy Score

    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

    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

    Assessed using pre-post change scores from the same ~30-minute session

  • +1 more other outcomes

Study Arms (2)

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.

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.

Other: No Intervention/Sham Comparator

Interventions

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.

Basic Body Awareness Therapy Intervention Group

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.

No Intervention/Sham Comparator: Control (Quiet Rest)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    PMID: 29723080BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 20332509BACKGROUND
  • 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.

    PMID: 7267933BACKGROUND
  • 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.

    PMID: 30472370BACKGROUND
  • 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.

    PMID: 23133619BACKGROUND
  • 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.

    PMID: 18329323BACKGROUND
  • 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.

    PMID: 26441373BACKGROUND
  • 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.

    PMID: 25451381BACKGROUND
  • 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.

    PMID: 26106345BACKGROUND
  • 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.

    PMID: 33450331BACKGROUND
  • 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.

    PMID: 16536641BACKGROUND

Study Officials

  • Ertuğrul Deniz Köse, Ph.D

    Amasya University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ertuğrul Deniz Köse, Ph.D

CONTACT

Eylem KÜÇÜK, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and the person delivering the intervention/control session cannot be blinded to group assignment due to the nature of the intervention. However, outcome assessors - specifically, the researchers responsible for EEG signal preprocessing, feature extraction, and interoceptive accuracy scoring - will be blinded to group allocation. Group codes will be masked during data analysis to minimize assessment and analytic bias.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 30, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.