Clinical trial NCT04679636: Effects of HRV Biofeedback on Autonomic Function and Nicotine Withdrawal Symptoms and Dependence in Smoking Cessation Adults
Official title: Effects of Heart Rate Variability Biofeedback on Promoting Autonomic Function and Decreasing Nicotine Withdrawal Symptoms and Dependence in Smoking Cessation Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, Insomnia
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: autonomic nerve function
timeFrame: baseline
measure: autonomic nerve function
timeFrame: 1 month
measure: autonomic nerve function
timeFrame: 2 month
measure: autonomic nerve function
timeFrame: 6 month
Secondary outcomes:
measure: symptom distress(Anxiety)
timeFrame: baseline
measure: symptom distress(Anxiety)
timeFrame: 1 month
measure: symptom distress(Anxiety)
timeFrame: 2 month
measure: symptom distress(Anxiety)
timeFrame: 6 month
measure: symptom distress(Depression)
timeFrame: baseline
measure: symptom distress(Depression)
timeFrame: 1 month
measure: symptom distress(Depression)
timeFrame: 2 month
measure: symptom distress(Depression)
timeFrame: 6 month
measure: symptom distress(Sleep)
timeFrame: baseline
measure: symptom distress(Sleep)
timeFrame: 1 month
measure: symptom distress(Sleep)
timeFrame: 2 month
measure: symptom distress(Sleep)
timeFrame: 6 month
measure: Cigarette Dependence
timeFrame: baseline
measure: Cigarette Dependence
timeFrame: 1 month
measure: Cigarette Dependence
timeFrame: 2 month
measure: Cigarette Dependence
timeFrame: 6 month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service Medical Center
Study officials:
References: