Effects of HRV Biofeedback on Autonomic Function and Nicotine Withdrawal Symptoms and Dependence in Smoking Cessation Adults
Primary Purpose
Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, Insomnia
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
heart rate variability biofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, Insomnia
Eligibility Criteria
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
Sites / Locations
- Tri-Service Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
receive biofeedback training for heart rate variability for eight weeks
receive conventional treatment
Outcomes
Primary Outcome Measures
autonomic nerve function
heart rate variability index
autonomic nerve function
heart rate variability index
autonomic nerve function
heart rate variability index
autonomic nerve function
heart rate variability index
Secondary Outcome Measures
symptom distress(Anxiety)
Beck Anxiety Inventory
symptom distress(Anxiety)
Beck Anxiety Inventory
symptom distress(Anxiety)
Beck Anxiety Inventory
symptom distress(Anxiety)
Beck Anxiety Inventory
symptom distress(Depression)
Beck Depression Inventory-II
symptom distress(Depression)
Beck Depression Inventory-II
symptom distress(Depression)
Beck Depression Inventory-II
symptom distress(Depression)
Beck Depression Inventory-II
symptom distress(Sleep)
Pittsburgh Sleep Quality Index
symptom distress(Sleep)
Pittsburgh Sleep Quality Index
symptom distress(Sleep)
Pittsburgh Sleep Quality Index
symptom distress(Sleep)
Pittsburgh Sleep Quality Index
Cigarette Dependence
Short-Form Cigarette Dependence Questionnaire
Cigarette Dependence
Short-Form Cigarette Dependence Questionnaire
Cigarette Dependence
Short-Form Cigarette Dependence Questionnaire
Cigarette Dependence
Short-Form Cigarette Dependence Questionnaire
Full Information
NCT ID
NCT04679636
First Posted
December 18, 2020
Last Updated
March 21, 2023
Sponsor
National Defense Medical Center, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04679636
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 26, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
receive biofeedback training for heart rate variability for eight weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
receive conventional treatment
Intervention Type
Behavioral
Intervention Name(s)
heart rate variability biofeedback
Intervention Description
receive biofeedback training for heart rate variability for eight weeks
Primary Outcome Measure Information:
Title
autonomic nerve function
Description
heart rate variability index
Time Frame
baseline
Title
autonomic nerve function
Description
heart rate variability index
Time Frame
1 month
Title
autonomic nerve function
Description
heart rate variability index
Time Frame
2 month
Title
autonomic nerve function
Description
heart rate variability index
Time Frame
6 month
Secondary Outcome Measure Information:
Title
symptom distress(Anxiety)
Description
Beck Anxiety Inventory
Time Frame
baseline
Title
symptom distress(Anxiety)
Description
Beck Anxiety Inventory
Time Frame
1 month
Title
symptom distress(Anxiety)
Description
Beck Anxiety Inventory
Time Frame
2 month
Title
symptom distress(Anxiety)
Description
Beck Anxiety Inventory
Time Frame
6 month
Title
symptom distress(Depression)
Description
Beck Depression Inventory-II
Time Frame
baseline
Title
symptom distress(Depression)
Description
Beck Depression Inventory-II
Time Frame
1 month
Title
symptom distress(Depression)
Description
Beck Depression Inventory-II
Time Frame
2 month
Title
symptom distress(Depression)
Description
Beck Depression Inventory-II
Time Frame
6 month
Title
symptom distress(Sleep)
Description
Pittsburgh Sleep Quality Index
Time Frame
baseline
Title
symptom distress(Sleep)
Description
Pittsburgh Sleep Quality Index
Time Frame
1 month
Title
symptom distress(Sleep)
Description
Pittsburgh Sleep Quality Index
Time Frame
2 month
Title
symptom distress(Sleep)
Description
Pittsburgh Sleep Quality Index
Time Frame
6 month
Title
Cigarette Dependence
Description
Short-Form Cigarette Dependence Questionnaire
Time Frame
baseline
Title
Cigarette Dependence
Description
Short-Form Cigarette Dependence Questionnaire
Time Frame
1 month
Title
Cigarette Dependence
Description
Short-Form Cigarette Dependence Questionnaire
Time Frame
2 month
Title
Cigarette Dependence
Description
Short-Form Cigarette Dependence Questionnaire
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tri-Service Medical Center
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Ju Chen, Ph.D.
Phone
886-2-87923100
Ext
18762
Email
judychen37@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of HRV Biofeedback on Autonomic Function and Nicotine Withdrawal Symptoms and Dependence in Smoking Cessation Adults
We'll reach out to this number within 24 hrs