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

NCT04679636 | Unknown DMC

• 1 other identifier: 2-2020-1204
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• symptom distress(Anxiety)

  baseline

• symptom distress(Anxiety)

  1 month

• symptom distress(Anxiety)

  2 month

• symptom distress(Anxiety)

  6 month

• symptom distress(Depression)

  baseline

Study Arms (2)

Experimental group

EXPERIMENTAL

receive biofeedback training for heart rate variability for eight weeks

Behavioral: heart rate variability biofeedback

Control group

NO INTERVENTION

receive conventional treatment

Interventions

heart rate variability biofeedback BEHAVIORAL

receive biofeedback training for heart rate variability for eight weeks

Experimental group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to quit smoking
• Clear consciousness
• Able to communicate in Mandarin or Taiwanese

You may not qualify if:

• 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

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

Tri-Service Medical Center

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder; Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of nursing

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 22, 2020
• Study Start: November 26, 2020
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)