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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, Insomnia
• Intervention / Treatment: Behavioral: heart rate variability biofeedback

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Tri-Service Medical Center
    • Contact: Yu-Ju Chen, Ph.D.; Phone Number: 18762 886-2-87923100; Email: judychen37@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; receive biofeedback training for heart rate variability for eight weeks	Behavioral: heart rate variability biofeedback; receive biofeedback training for heart rate variability for eight weeks
No Intervention: Control group; receive conventional treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Substance Withdrawal Syndrome
• Other Study ID Numbers: 2-2020-1204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No