An interventional study of heart rate variability biofeedback in Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, Insomnia, sponsored by National Defense Medical Center, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by National Defense Medical Center, Taiwan · Not applicable, Interventional, and Treatment
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.
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's planned enrollment of 80 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →National Defense Medical Center, Taiwan is the lead sponsor of 63 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
receive biofeedback training for heart rate variability for eight weeks
Behavioral: heart rate variability biofeedback
receive conventional treatment
receive biofeedback training for heart rate variability for eight weeks
autonomic nerve function
heart rate variability index
Time frame: baseline
autonomic nerve function
heart rate variability index
Time frame: 1 month
autonomic nerve function
heart rate variability index
Time frame: 2 month
autonomic nerve function
heart rate variability index
Time frame: 6 month
symptom distress(Anxiety)
Beck Anxiety Inventory
Time frame: baseline
symptom distress(Anxiety)
Beck Anxiety Inventory
Time frame: 1 month
symptom distress(Anxiety)
Beck Anxiety Inventory
Time frame: 2 month
symptom distress(Anxiety)
Beck Anxiety Inventory
Time frame: 6 month
symptom distress(Depression)
Beck Depression Inventory-II
Time frame: baseline
symptom distress(Depression)
Beck Depression Inventory-II
Time frame: 1 month
symptom distress(Depression)
Beck Depression Inventory-II
Time frame: 2 month
symptom distress(Depression)
Beck Depression Inventory-II
Time frame: 6 month
symptom distress(Sleep)
Pittsburgh Sleep Quality Index
Time frame: baseline
symptom distress(Sleep)
Pittsburgh Sleep Quality Index
Time frame: 1 month
symptom distress(Sleep)
Pittsburgh Sleep Quality Index
Time frame: 2 month
symptom distress(Sleep)
Pittsburgh Sleep Quality Index
Time frame: 6 month
Cigarette Dependence
Short-Form Cigarette Dependence Questionnaire
Time frame: baseline
Cigarette Dependence
Short-Form Cigarette Dependence Questionnaire
Time frame: 1 month
Cigarette Dependence
Short-Form Cigarette Dependence Questionnaire
Time frame: 2 month
Cigarette Dependence
Short-Form Cigarette Dependence Questionnaire
Time frame: 6 month
Plan to share: No
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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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National Defense Medical Center, Taiwan