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

NCT ID: NCT04679636

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-26
• Study Completion Date: 2024-03-31

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.

Conditions

Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

receive biofeedback training for heart rate variability for eight weeks

Group Type: EXPERIMENTAL

heart rate variability biofeedback

Intervention Type: BEHAVIORAL

receive biofeedback training for heart rate variability for eight weeks

Control group

receive conventional treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

heart rate variability biofeedback

receive biofeedback training for heart rate variability for eight weeks

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Defense Medical Center, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Yu-Ju Chen

Dean of nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tri-Service Medical Center

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Yu-Ju Chen, Ph.D.

Role: primary

judychen37@gmail.com

886-2-87923100 ext. 18762

Other Identifiers

2-2020-1204

Identifier Type: -

Identifier Source: org_study_id