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临床试验/NCT07713407
NCT07713407尚未招募不适用

The Effect of the Modified Mitchell Relaxation Method on Acute Cardiac Autonomic Modulation

Balikesir University0 个研究点目标入组 122 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
122
主要终点
RMSSD - Root Mean Square of Succesive Differences of RR Peaks of EKG

研究概览

简要总结

The purpose of this multi-center, randomized controlled trial is to investigate the acute effects of the standard Laura Mitchell Physiological Relaxation Method versus a Modified Mitchell Relaxation Version on cardiac autonomic modulation (heart rate variability). The study will include 122 participants aged 18-65 who score 10 or higher on the Generalized Anxiety Disorder-7 (GAD-7) scale, indicating high anxiety and potentially reduced parasympathetic control. Participants will be randomly allocated into two equal groups (n=61 per group) using a block randomization system with a concealed envelope method. To control for expectation bias, an incomplete disclosure protocol will be utilized, ensuring participants remain blinded to their specific group allocation. Both interventions will last 35 minutes and will be delivered via audio recordings in a supine position (Mitchell's 'Position A') to prevent investigator bias. Cardiac autonomic responses will be assessed using a Polar H10 chest strap to analyze Heart Rate Variability (HRV) before, during, and after the sessions. Blood pressure and respiration rate will also be monitored as secondary outcomes

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being 18-65 years old.
  • Having stress and anxiety

排除标准

  • Taking cardioactive/psychotropic drugs.
  • Having a diagnosis of cardiovascular disease.

结局指标

主要结局

RMSSD - Root Mean Square of Succesive Differences of RR Peaks of EKG

时间窗: During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.

Root Mean Square of Succesive Differences of RR Peaks of EKG

次要结局

  • Time-Domain Heart Rate Variability Parameters (SDNN, RMSSD, Mean RR Interval)(During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.)
  • Absolute Spectral Power HRV Parameters (LF, HF)(During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.)
  • LF/HF Ratio(During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.)
  • Poincaré Plot HRV Parameters (SD1, SD2)(During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.)
  • Non-linear HRV Complexity Parameters (SD1/SD2 Ratio, Sample Entropy)(During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.)

研究者

发起方
Balikesir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Utku Berberoğlu

assistant professor

Balikesir University

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