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

Study Overview
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Brief Summary
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To evaluate the added value of Sophrology on the intensity of craving during cigarette withdrawal.

Detailed Description
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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.

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

Conditions
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Craving, Cigarette Smoking

Intervention / Treatment
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* Behavioral: Sophrology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sophrology<br>the patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology | Behavioral: Sophrology<br>* Patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology.<br>|
| No Intervention: Control<br>the patient must make 7 visits with interviews and questionnaires | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cigarettes smoked per day | Number of cigarettes smoked per day | 6 months after the end of consultations | 
| Motivation to Quit Smoking by Numerical Scale (0 to 5) | Assessment of Motivation to Quit Smoking | 6 months after the end of consultations | 
| Measuring Confidence in Withdrawal Success by numerical scale (0 to 5) | Measuring Confidence in Withdrawal Success | 6 months after the end of consultations | 
| Evaluation of sleep by numerical scale (0 to 5) | Evaluation of sleep quality | 6 months after the end of consultations | 
| Evaluation of irritability by numerical scale (0 to 5) | Evaluation of irritability levels | 6 months after the end of consultations | 
| Fatigue levels by numerical scale (0 to 5) | Evaluation of fatigue levels | 6 months after the end of consultations | 
| Fagerström test (0 to 11) | Comparison of dependency | 6 months after the end of consultations | 
| CO (carbon monoxide) test | Comparison of the evolution of the CO | 6 months after the end of consultations | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sophrology