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NCT04700306 Clinical Trial

Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal

Cigarette Smoking Clinical Trial

— SOPHCIG  

Official title:
Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04700306
Other study ID # SOPHCIG
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 23, 2021
Est. completion date December 23, 2025

Study information
Verified date March 2024
Source Centre Hospitalier Intercommunal Creteil
Contact Sylvie Ané
Phone 0145175035
Email sylvie.ane@chicreteil.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the added value of Sophrology on the intensity of craving during cigarette withdrawal.

Description:

Pilot study to evaluate the impact of sophrology on the intensity of craving and on certain determinants of cigarette consumption: number of cigarettes, anxiety, degree of dependence, motivation, confidence, fatigue, irritability, quality of sleep. This pilot study could serve as a basis for the development of research on a larger cohort.

Recruitment information / eligibility
Status Recruiting
Enrollment 36
Est. completion date December 23, 2025
Est. primary completion date December 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - First outpatient consultation in tobacco addiction department - Consumption greater than or equal to 35 cigarettes per week - Minimum age: 18 years old / Maximum age: 75 years old - Absence of co-addiction of alcohol, other products and behavioural addictions (except if withdrawal for more than 1 year) - Commitment by the patient not to practice hypnosis or mindfulness while participating in the study - Mastering reading and writing skills - Acceptance to participate in the protocol - Affiliated to a social security system Exclusion Criteria: - Patient-reported psychosis - Pregnant women - Participation in other intervention research - Patient under guardianship or curatorship - Refusal to participate in the study

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Sophrology
Patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology.

Locations
Country Name City State
France CHI Créteil Equipe de liaison et de soins en addictologie (ELSA) Créteil
France CHU Henri Mondor Service d'addictologie Créteil

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary FTCQ-12 questionnaire (French Tobacco Craving Questionnaire - 12 items) (0 to 84) Comparison of the inte craving between the sophrology group and the control group at nsity of 6 months after the end of consultations, using the FTCQ-12 questionnaire. 6 months after the end of consultations
Secondary Number of cigarettes smoked per day Number of cigarettes smoked per day 6 months after the end of consultations
Secondary Motivation to Quit Smoking by Numerical Scale (0 to 5) Assessment of Motivation to Quit Smoking 6 months after the end of consultations
Secondary Measuring Confidence in Withdrawal Success by numerical scale (0 to 5) Measuring Confidence in Withdrawal Success 6 months after the end of consultations
Secondary Evaluation of sleep by numerical scale (0 to 5) Evaluation of sleep quality 6 months after the end of consultations
Secondary Evaluation of irritability by numerical scale (0 to 5) Evaluation of irritability levels 6 months after the end of consultations
Secondary Fatigue levels by numerical scale (0 to 5) Evaluation of fatigue levels 6 months after the end of consultations
Secondary Fagerström test (0 to 11) Comparison of dependency 6 months after the end of consultations
Secondary CO (carbon monoxide) test Comparison of the evolution of the CO 6 months after the end of consultations
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