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

29 de julho de 2026 atualizado por: Ertugrul Deniz Kose

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

84

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comparador Falso: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in EEG Theta Band Power
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in interoceptive accuracy score
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Correlation Between Change in EEG Theta Band Power and Change in Interoceptive Accuracy Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Ertuğrul Deniz Köse, Ph.D, Amasya University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

31 de agosto de 2027

Conclusão do estudo (Estimado)

31 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

17 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de julho de 2026

Primeira postagem (Real)

30 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • Amasya Uni-BBAT

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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