Skip to content

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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04700306
Acronym
SOPHCIG
Enrollment
17
Registered
2021-01-07
Start date
2021-06-23
Completion date
2024-09-09
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking, Craving

Keywords

Sophrology

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.

Interventions

BEHAVIORALSophrology

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

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
FTCQ-12 questionnaire (French Tobacco Craving Questionnaire - 12 items) (0 to 84)6 months after the end of consultationsComparison 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

MeasureTime frameDescription
Motivation to Quit Smoking by Numerical Scale (0 to 5)6 months after the end of consultationsAssessment of Motivation to Quit Smoking
Measuring Confidence in Withdrawal Success by numerical scale (0 to 5)6 months after the end of consultationsMeasuring Confidence in Withdrawal Success
Evaluation of sleep by numerical scale (0 to 5)6 months after the end of consultationsEvaluation of sleep quality
Number of cigarettes smoked per day6 months after the end of consultationsNumber of cigarettes smoked per day
Fatigue levels by numerical scale (0 to 5)6 months after the end of consultationsEvaluation of fatigue levels
Fagerström test (0 to 11)6 months after the end of consultationsComparison of dependency
CO (carbon monoxide) test6 months after the end of consultationsComparison of the evolution of the CO
Evaluation of irritability by numerical scale (0 to 5)6 months after the end of consultationsEvaluation of irritability levels

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026