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临床试验/CTRI/2024/01/061354
CTRI/2024/01/061354尚未招募1 期

Respiratory Sinus Arrhythmia, a Biofeedback technique as a Biobehavioral approach for anxiety symptoms.

Deeksha1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年1月18日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
For HRV,

研究概览

简要总结

Anxiety is a feeling of instability such as fright that can be mild or acute. Anxiety being shown have a strong relationship to emotional & behavioural problems, thereby lack of selfcare having unhealthy lifestyle are risk factors for anxiety among younger generation. Untreated anxiety can have a notable impact on cognitive performance and academic achievement. When individuals experience chronic anxiety, then often remain in a high alertness, which can lead to increased levels of stress hormone called cortisol. High levels of cortisol can affect the cognitive function. Heart Rate Variability (HRV) is a time interval between heart beats which is a maker of one’s wellbeing. Individuals who having anxiety are characterized by chronically low HRV status. HRV self-measurement is simple to use and practice tool which is guided by timed breathing that allows for an essential identification of resonance frequency to maximize personal HRV training. By using HRV biofeedback training, the HRV will increases in people with anxious symptoms, and it will also reduce cortisol levels. By correcting the feedback loop, we try to reduce the anxious symptoms and thereby also see whether there is improvement in the cognition function. Volunteers would be screened using Zung Anxiety scale self-assessment tool. The volunteers with anxiety scale scoring above 45 will be taken into the study and would be randomized into Intervention and Non-intervention groups. Here the Non-intervention group acts as a control group with anxious symptoms.  Both the groups to have baseline parameters for HRV and cognition test.  It will take approximately 1 h

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Individuals with anxious symptoms between 18 to 30 years of both gender who are able to read & write English and individuals without any psychiatric disorders can participate in this study.

排除标准

  • Individual without anxious symptoms Individual with any form of abnormal cardiac rhythm, Cognitive impairment, diagnosed anxiety disorder or any other psychiatric disorders are excluded and chronic illness on medication.

结局指标

主要结局

For HRV,

时间窗: At Baseline 6 weeks of intervention

1.Total Power

时间窗: At Baseline 6 weeks of intervention

2.High Frequency

时间窗: At Baseline 6 weeks of intervention

3.Low Frequency

时间窗: At Baseline 6 weeks of intervention

4.HF in Normalized Units

时间窗: At Baseline 6 weeks of intervention

5.LF in Normalized Units

时间窗: At Baseline 6 weeks of intervention

6.HF/LF Ratio

时间窗: At Baseline 6 weeks of intervention

7.Mean-RR

时间窗: At Baseline 6 weeks of intervention

8.SDNN

时间窗: At Baseline 6 weeks of intervention

9.RMSSD

时间窗: At Baseline 6 weeks of intervention

10.NN50

时间窗: At Baseline 6 weeks of intervention

11.pNN50

时间窗: At Baseline 6 weeks of intervention

For Cognition,

时间窗: At Baseline 6 weeks of intervention

1.Accuracy(%)

时间窗: At Baseline 6 weeks of intervention

2.Errors

时间窗: At Baseline 6 weeks of intervention

3.Duration

时间窗: At Baseline 6 weeks of intervention

4.Response Time

时间窗: At Baseline 6 weeks of intervention

次要结局

未报告次要终点

研究者

发起方
Deeksha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Deeksha

KMC Manipal

研究点 (1)

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