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临床试验/NCT07437833
NCT07437833招募中不适用

Psychophysiological Responses to Six 15-Minute Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder: A Single-Case Study

Poznan University of Physical Education1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2026年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1
试验地点
1
主要终点
Mean EEG spectral power in theta, alpha, low beta, high beta, gamma frequency bands during resting-state (eyes-open and eyes-closed)

研究概览

简要总结

This study aims to explore how six short, 15-minute self-regulation techniques affect the body and brain in a female adult with ADHD and stabilized bipolar disorder. The techniques being tested include:

  • Aerobic exercise
  • Controlled breathing (cyclic sighing)
  • Aromatherapy with lavender essential oil
  • Listening to specific music (Solfeggio 528 Hz)
  • Virtual reality relaxation with forest imagery
  • Emotional Freedom Technique (EFT) tapping One session of quiet sitting with eyes open serves as a comparison.

The participant will attend one 15-minute session per week for each technique. Before and after each session, the researchers will measure:

  • Heart rate and heart rate variability
  • Stress levels using Subjective Units of Distress Scale
  • Mood using a questionnaire
  • Blood pressure
  • Brain activity using EEG
  • Memory performance with a simple test (N-back)
  • Pain sensitivity The goal is to understand how these short, non-invasive techniques influence both physiological and psychological responses. Sessions are safe, short, and designed to involve minimal risk. The findings may help guide future research on relaxation and exercise strategies for people with ADHD and bipolar disorder.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of ADHD and bipolar disorder (type I or II) in stable remission.
  • No active depressive, manic, or psychotic episodes for at least 2 years.
  • No use of psychotropic medications, including mood stabilizers, antidepressants, antipsychotics, or ADHD medications, for at least 2 years.
  • No chronic somatic diseases (including neurological, cardiovascular, or metabolic disorders).
  • Regular sleep-wake rhythm during the week preceding the study.
  • Non-smoker.
  • No night-shift work in the week preceding the study.

排除标准

  • Acute medical conditions that could affect study procedures.
  • Use of medications in the past 3 months that influence cardiovascular or neurological parameters.
  • Consumption of alcohol or psychoactive substances on the day before or day of the study.
  • Intense physical activity on the day before or day of the study.
  • Contraindications to moderate-intensity exercise on a cycle ergometer (e.g., recent injuries, chronic musculoskeletal conditions).
  • Contraindications to EEG measurement (e.g., scalp skin conditions preventing proper electrode placement, hypersensitivity to conductive gels or pastes).

结局指标

主要结局

Mean EEG spectral power in theta, alpha, low beta, high beta, gamma frequency bands during resting-state (eyes-open and eyes-closed)

时间窗: Baseline: immediately before intervention; Post-intervention: immediately after completion of the intervention period

Mean spectral power in theta, alpha, low beta, high beta, and gamma frequency bands derived from resting-state EEG recordings collected during eyes-open and eyes-closed conditions. Spectral power will be calculated separately for eyes-open and eyes-closed resting-state conditions.

Heart Rate Variability (HRV)

时间窗: Baseline (average over 5-minute resting-state immediately before intervention); During intervention (average over entire session, periprocedural); Post-intervention (average over 5-minute resting-state immediately after intervention).

HRV will be recorded at three time points. Baseline HRV will be calculated as the average over a 5-minute resting-state period immediately before intervention. HRV during the intervention will be calculated as the average over the entire intervention session (periprocedural). Post-intervention HRV will be calculated as the average over a 5-minute resting-state period immediately after intervention.

次要结局

  • Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during N-back task(Baseline (during N-back task immediately before each intervention session, periprocedural); Post-intervention (during N-back task immediately after each intervention session, periprocedural))
  • Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during intervention session(During intervention session (periprocedural, averaged over entire session).)
  • Perceived Stress measured with the Subjective Units of Distress Scale (SUDS)(Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session)
  • Cognitive Performance (N-back)(Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.)
  • Blood Pressure(Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session)
  • Pain Threshold(Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.)
  • Positive and Negative Affect measured with the Positive and Negative Affect Schedule - Short Form (PANAS-SF)(Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session)
  • Heart Rate(Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.)

研究者

发起方
Poznan University of Physical Education
申办方类型
Other
责任方
Sponsor

研究点 (1)

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