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

2026年7月29日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

84

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
假比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in EEG Theta Band Power
大体时间: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
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Change in interoceptive accuracy score
大体时间: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

其他结果措施

结果测量
措施说明
大体时间
Correlation Between Change in EEG Theta Band Power and Change in Interoceptive Accuracy Score
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ertuğrul Deniz Köse, Ph.D、Amasya University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年8月31日

研究完成 (估计的)

2028年3月31日

研究注册日期

首次提交

2026年7月17日

首先提交符合 QC 标准的

2026年7月29日

首次发布 (实际的)

2026年7月30日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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