Ear-acupressure for smoking cessation: a randomised controlled trial (RCT)

Not Applicable

Completed

• Conditions: Smoking cessation; Respiratory - Other respiratory disorders / diseases; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12611000761965
• Lead Sponsor: RMIT University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-20
• Study Completion: 2012-01-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Smoke 10 or more cigarettes a day for at least one year; intend to stop smoking on the agreed quit date; agree to make themselves available for the period of the study; and
provide informed consent.

Exclusion Criteria

1. Current pathological condition of the ear (e.g. otitis externa);
2. Wearing a hearing aid;
3. History of allergy to adhesive dressing;
4. Current use of NRT;
5. Currently taking bupropion or varenicline;
6. Currently taking anti-depressant or anti-psychotic medications;
7. Currently undertaking a quit smoking program (e.g. counselling);
8. Current alcohol or substance abuse;
9. Currently enrolled into another clinical study;
10. Pregnancy;
11. Other persons from the same household are included in the study already;
12. Have used ear-acupuncture or ear-acupressure for a respiratory condition and/or smoking cessation within the last 12 months;
13. Are an acupuncture student or a practitioner; or
14. Do not read or understand English.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Smoking cessation assessed by case record form and exhaled CO[End of treatment (8 weeks after randomisation), end of follow up (20 weeks after intervention commencement)];Nicotine withdrawal symptoms assessed using the seven item Mood and Physical Symptoms Scale (MPSS)[End of treatment (8 weeks after randomisation), end of follow up (20 weeks after intervention commencement)]

Secondary Outcome Measures

Name	Time	Method
icotine Replacement Therapy consumption assessed by case record form[Baseline, treatment period (8 weeks) and follow up period (12 weeks)];Number of days of continuous abstinence of cigarette smoking assessed by case report form[Baseline, treatment period (8 weeks) and follow up period (12 weeks)];Frequency of relapses (number of cigarettes used) assessed by case report form[Baseline, treatment period (8 weeks) and follow up period (12 weeks)];Safety profile of ear-acupressure assessed by case report form[Treatment period (8 weeks) and follow up period (12 weeks)];Body weight assessed by measurement by the therapist[Baseline, treatment period (8 weeks) and follow up period (12 weeks)];Quality of life assessed using Short Form-36[End of treatment (8 weeks after randomisation), end of follow up (20 weeks after intervention commencement)]