Effects of Auricular Acupressure and Group Counseling on Smoking Cessation Tobacco Withdrawal Symptoms

NCT02916628 | Terminated DMC

• 1 other identifier: 2013-03-058
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

Objective The purpose of this study is to examine the effects of auricular acupressure and group counseling with positive psychology and motivational interviewing on smoking cessation and tobacco withdrawal symptoms. Methods This study is a single blind randomized controlled trial. This study has been performed at a University in South Korea. 180 smokers and 60 non-smokers will be recruited. Smokers will be randomly assigned to three groups: group 1 (auricular acupressure + group counseling); group 2 (placebo acupressure + group counseling); and the control group (self-help smoking cessation). Group counseling is undertaken once per week for 6 weeks. Auricular acupressure using acupellets is performed for 6 weeks continuously.

Conditions

Smoking

Keywords

smoking cessation; group counseling; acupressure; serotonin; depressive symptoms; resilience

Outcome Measures

Primary Outcomes (5)

• smoking cessation: Change from Baseline Smoking status at 3,6 months, 1 year, 2 years

  self-report

  baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years

• Minnesota Tobacco Withdrawal Scale(MTWS):Change from Baseline tobacco withdrawal symptoms at 2,3,4,5,6 weeks

  The MTWS was developed to measure nicotine withdrawal symptoms \[22\]. The MTWS consists of nine items with a 4-point Likert scale. Higher scores indicate more severe withdrawal symptoms. Cronbach's alpha was .88 in 118 Korean Americans. Factor analysis showed two factors: mental difficulties and physical difficulties. These two factors explained 66% of the variance

  baseline,2,3,4,5,6 weeks

• multidimensional coping scale: Change from Baseline coping skills at 6 weeks, 6 months, 1 year, 2 years

  The multidimensional coping scale was developed by Jeon, KG(1994). It consists 50 items including personal, social, and religious coping. The multidimensional coping scale is composed of personal, social, and religious coping resources: (Personal Coping Resources), active coping, passive withdrawal, emotional expression, active forgetting, perseverance, positive interpretation, positive comparison, accommodation, fatalism, self-criticism, emotional pacification; (Social Coping Resources), problem-solving social support seeking, emotional social support seeking; (Religious Coping Resources), religious seeking.

  baseline, 6 weeks, 6 months, 1 year, 2 years

• urine cotinine test:Change from 6-week urine cotinine at 6 months, 1 year, 2 years

  Cotinine is the first-stage metabolite of nicotine. The urine cotinine test using a fresh urine specimen was used to check smoking cessation. There was neither any benefit for smoking cessation in this study nor any legal problem to smoking cigarettes in South Korea. Therefore, participants were allowed to provide urine specimens without close monitoring. The urine cotinine test is a rapid, one-step, immunochromatographic assay for the qualitative detection of cotinine in human urine at 200 ng/ml cut-off concentration. Three drops of urine were transferred to the urine cotinine test apparatus (Brand name: Lungene one step rapid test, Company: Hangzhou Clongene Biotech Co., Ltd, made in China). Two lines indicated a negative result, while one line indicated a positive result. For participants who did not smoke for at least one week, negative test results were expected. Urine cotinine was checked at the 6-week post-test and 6-month follow-up.

  6 weeks, 6 months, 1 year, 2 years

• serum cotinine levels:Change from 6-week serum cotinine levels at 6 months, 1 year, 2 years

  Serum cotinine levels reflect recent exposure to nicotine in tobacco smoke. Nonsmoking is usually defined as a serum cotinine level of less than or equal to 10 ng/mL (Pirkle et al., 1996).

  6 weeks, 6 months, 1 year, 2 years

Secondary Outcomes (4)

• Patient Health Questionnaire-9

  6 weeks, 6 months, 1 year, 2 years

• Resilience

  6 weeks, 6 months, 1 year, 2 years

• Serum serotonin

  6 weeks, 6 months, 1 year, 2 years

• Eysenck Personality Inventory

  baseline

Study Arms (4)

Group 1

EXPERIMENTAL

auricular acupressure + group counseling

Behavioral: group counseling; Device: Auricular acupressure

Group 2

PLACEBO COMPARATOR

placebo acupressure + group counseling

Behavioral: group counseling; Device: placebo acupressure

Group 3

NO INTERVENTION

self-help smoking cessation

Group 4

NO INTERVENTION

Non-smokers

Interventions

group counseling BEHAVIORAL

Group counseling with positive psychology and motivational interviewing was undertaken once per week for 6 weeks.

Group 1; Group 2

Auricular acupressure DEVICE

Auricular acupressure using acupellets was performed for 6 weeks continuously

Group 1

placebo acupressure DEVICE

Placebo acupellets were prepared without metal projections, and placed on both sides in the same areas of the ear as the active condition.

Group 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• smokers who:
• were more than 19 years
• could complete questionnaires
• have smoked longer than 6 months
• wanted to quit smoking cigarettes
• did not have an infection on the surface of the ears.

You may not qualify if:

• smokers who
• were using nicotine patches or medications for smoking cessation
• had allergies to copper or aluminum
• had used illegal drugs
• were pregnant.

Sponsors & Collaborators

• Inha University Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation; Depression

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 27, 2016
• Study Start: July 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: December 1, 2019
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

KR (1)