Effects of HRV Biofeedback on Autonomic Function and Nicotine Withdrawal Symptoms and Dependence in Smoking Cessation Adults

Study Overview
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Brief Summary
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This study is a randomized controlled trial. It is estimated that 80 quitters will be recruited, and they will be randomly included in the experimental group and 40 in the control group. The experimental group will be involved in heart rate variability biological feedback training for eight weeks, and the control group will receive conventional treatment. Use the scale to assess the symptoms of nicotine withdrawal-anxiety, depression and insomnia, as well as the degree of nicotine dependence before and after the intervention; the autonomic nervous function of the participants was measured by heart rhythm variation before and after the intervention; in addition, the cessation of smoking was tracked by telephone once a month for six Months. Discuss interventional biological feedback training and evaluate its effectiveness in improving heart rate variability, which represents autonomic nervous function, and alleviating nicotine withdrawal anxiety, insomnia, and depression symptoms, as well as nicotine dependence.

Detailed Description
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Smoking cessation has been one of the priorities in public health for many years, because the severity of the disease and the social and economic losses caused by smoking cannot be ignored. Among them, nicotine dependence is one of the important issues in quitting smoking. Nicotine withdrawal symptoms often make the quitters' actions fail, especially anxiety, insomnia, and depression, which further affect the lives of quitters. If an intervention can be provided to improve the nicotine withdrawal symptoms of quitters and reduce nicotine dependence, it should be able to improve the effectiveness of smoking cessation.This study is a randomized controlled trial to facilitate sampling. It is expected that 80 quitters will be recruited at the smoking cessation clinic of the medical center through the referral of the attending physician, and 40 will be randomly included in the experimental group and the control group. The experimental group will receive biofeedback training for heart rate variability for eight weeks, while the control group will receive conventional treatment. Use the scale to assess nicotine withdrawal symptoms before and after intervention-the degree of anxiety (Beck Anxiety Inventory), depression (Beck Depression Inventory) and insomnia (Pittsburgh Sleep Quality Index), And the degree of nicotine dependence (Nicotine Dependence Scale; Fagerstrom Test for Nicotine Dependence); the autonomic nerve function of the participants was measured by heart rhythm variability before and after the intervention; in addition, the cessation of smoking was tracked by telephone once a month for six months. This study is mainly to explore interventional biological feedback training to evaluate its effectiveness in improving the representative autonomic nervous function-heart rate variability and alleviating nicotine withdrawal anxiety, insomnia and depression symptoms and nicotine dependence.

Official Title
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Effects of Heart Rate Variability Biofeedback on Promoting Autonomic Function and Decreasing Nicotine Withdrawal Symptoms and Dependence in Smoking Cessation Adults

Conditions
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Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, Insomnia

Intervention / Treatment
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* Behavioral: heart rate variability biofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to quit smoking Clear consciousness Able to communicate in Mandarin or Taiwanese Exclusion Criteria: Diagnosed with asthma or chronic obstructive pulmonary disease Diagnosed with nervous system Diagnosis of mental illness Arrhythmia, use of cardiac pacemakers, and atrioventricular conduction disorders

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>receive biofeedback training for heart rate variability for eight weeks | Behavioral: heart rate variability biofeedback<br>* receive biofeedback training for heart rate variability for eight weeks<br>|
| No Intervention: Control group<br>receive conventional treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| autonomic nerve function | heart rate variability index | baseline | 
| autonomic nerve function | heart rate variability index | 1 month | 
| autonomic nerve function | heart rate variability index | 2 month | 
| autonomic nerve function | heart rate variability index | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom distress(Anxiety) | Beck Anxiety Inventory | baseline | 
| symptom distress(Anxiety) | Beck Anxiety Inventory | 1 month | 
| symptom distress(Anxiety) | Beck Anxiety Inventory | 2 month | 
| symptom distress(Anxiety) | Beck Anxiety Inventory | 6 month | 
| symptom distress(Depression) | Beck Depression Inventory-II | baseline | 
| symptom distress(Depression) | Beck Depression Inventory-II | 1 month | 
| symptom distress(Depression) | Beck Depression Inventory-II | 2 month | 
| symptom distress(Depression) | Beck Depression Inventory-II | 6 month | 
| symptom distress(Sleep) | Pittsburgh Sleep Quality Index | baseline | 
| symptom distress(Sleep) | Pittsburgh Sleep Quality Index | 1 month | 
| symptom distress(Sleep) | Pittsburgh Sleep Quality Index | 2 month | 
| symptom distress(Sleep) | Pittsburgh Sleep Quality Index | 6 month | 
| Cigarette Dependence | Short-Form Cigarette Dependence Questionnaire | baseline | 
| Cigarette Dependence | Short-Form Cigarette Dependence Questionnaire | 1 month | 
| Cigarette Dependence | Short-Form Cigarette Dependence Questionnaire | 2 month | 
| Cigarette Dependence | Short-Form Cigarette Dependence Questionnaire | 6 month |