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

Not Applicable

Recruiting

• Conditions: Craving; Cigarette Smoking
• Interventions: Behavioral: Sophrology

• Registration Number: NCT04700306
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Study Start: 2021-06-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-12-23
• Study Completion: 2025-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sophrology	Sophrology	the patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology

Primary Outcome Measures

Name	Time	Method
FTCQ-12 questionnaire (French Tobacco Craving Questionnaire - 12 items) (0 to 84)	6 months after the end of consultations	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

CHU Henri Mondor Service d'addictologie; 🇫🇷 Créteil, France

CHI Créteil Equipe de liaison et de soins en addictologie (ELSA); 🇫🇷 Créteil, France