Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, Insomnia Clinical Trial
Official title:
Effects of Heart Rate Variability Biofeedback on Promoting Autonomic Function and Decreasing Nicotine Withdrawal Symptoms and Dependence in Smoking Cessation Adults
| Verified date | March 2023 |
| Source | National Defense Medical Center, Taiwan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | March 31, 2024 |
| Est. primary completion date | December 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | Inclusion Criteria: 1. Willing to quit smoking 2. Clear consciousness 3. Able to communicate in Mandarin or Taiwanese Exclusion Criteria: 1. Diagnosed with asthma or chronic obstructive pulmonary disease 2. Diagnosed with nervous system 3. Diagnosis of mental illness 4. Arrhythmia, use of cardiac pacemakers, and atrioventricular conduction disorders |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Tri-Service Medical Center | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| National Defense Medical Center, Taiwan |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | autonomic nerve function | heart rate variability index | baseline | |
| Primary | autonomic nerve function | heart rate variability index | 1 month | |
| Primary | autonomic nerve function | heart rate variability index | 2 month | |
| Primary | autonomic nerve function | heart rate variability index | 6 month | |
| Secondary | symptom distress(Anxiety) | Beck Anxiety Inventory | baseline | |
| Secondary | symptom distress(Anxiety) | Beck Anxiety Inventory | 1 month | |
| Secondary | symptom distress(Anxiety) | Beck Anxiety Inventory | 2 month | |
| Secondary | symptom distress(Anxiety) | Beck Anxiety Inventory | 6 month | |
| Secondary | symptom distress(Depression) | Beck Depression Inventory-II | baseline | |
| Secondary | symptom distress(Depression) | Beck Depression Inventory-II | 1 month | |
| Secondary | symptom distress(Depression) | Beck Depression Inventory-II | 2 month | |
| Secondary | symptom distress(Depression) | Beck Depression Inventory-II | 6 month | |
| Secondary | symptom distress(Sleep) | Pittsburgh Sleep Quality Index | baseline | |
| Secondary | symptom distress(Sleep) | Pittsburgh Sleep Quality Index | 1 month | |
| Secondary | symptom distress(Sleep) | Pittsburgh Sleep Quality Index | 2 month | |
| Secondary | symptom distress(Sleep) | Pittsburgh Sleep Quality Index | 6 month | |
| Secondary | Cigarette Dependence | Short-Form Cigarette Dependence Questionnaire | baseline | |
| Secondary | Cigarette Dependence | Short-Form Cigarette Dependence Questionnaire | 1 month | |
| Secondary | Cigarette Dependence | Short-Form Cigarette Dependence Questionnaire | 2 month | |
| Secondary | Cigarette Dependence | Short-Form Cigarette Dependence Questionnaire | 6 month |