CHU Poitiers
Poitiers, 86000, France
Location status: Recruiting
Location contact
Claire LAFAY, Dr
CONTACT
NCT Number: NCT05589220
The study is a randomized, controlled trial comparing music therapy associated to NRT versus NRT alone to evaluate the value of music therapy in improving the management of craving among 120 student smokers (18 to 25 years old). This pilot multi-method study will combine the methodology of clinical trials with qualitative techniques used in social sciences to show the interest of a digital music therapy tool, adapted to a young audience.
Interested in participating?
Request Info18 year–25 year
All sexes
Interventional
Not applicable
Poitiers, 86000, France
Location status: Recruiting
Claire LAFAY, Dr
CONTACT
The participants will be recruited at the Clinical Investigation Center (CIC) of the University Hospital of Poitiers. At baseline visit, they will be randomly 1:1 assigned to receive either music therapy and NRT or NRT alone for 3 months.
During the 3 months after TQD (Target Quit Date), 3 visits will be performed by practitioners at the CIC. Practitioners will register smoking status of the participant, exhaled carbon monoxide concentration, body weight and all adverse events. Participants will answer questionnaires (FTCQ-12, HAD, MNWS, UPPS).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Music therapy carried out with MUSIC CARE©
NRT: Nicotine Patch, Nicotine Gum
Time frame: Month 1
Score of French Version of the Tabacco Craving Questionnaire-12 (FTCQ-12). It consist of 12 questions, each rated on a likert-type scale with 7 response options. Lower scores mean a better outcome.
Time frame: Month 3
Music therapy sessions compliance. Number and reasons for not attending music thearpy sessions.
Time frame: Month [2; 3]
Score of French Version of the Tabacco Craving Questionnaire-12 (FTCQ-12). It consist of 12 questions, each rated on a likert-type scale with 7 response options. Lower scores mean a better outcome.
Time frame: Month [1;2; 3]
HAD (Hospital Anxiety and Depression Scale) score. Maximum score for each score (total A, total D) = 21. Score over 10 definites state of anxiety.
Lower scores mean a better outcome.
Time frame: Month [1;2; 3]
MNWS (Minnesota Nicotine Withdrawal Scale) score. It consist of 8 questions, each rated on a likert-type scale with 0-4 response options. Lower scores mean a better outcome.
Time frame: Month [1;2; 3]
UPPS (Impulsive Behavior Scale) score. It consist of 20 questions, each rated on a likert-type scale with 1-4 response options. Lower scores mean a better outcome.
Time frame: Month [1;2; 3]
Self reported abstinence or smoking reduction >or=50%
Contact information is provided by the study sponsor or research team.
Poitiers University Hospital
Other
Multi-method Pilot Study to Evaluate the Interest of Music Therapy Associated to Nicotine Replacement Therapy (NRT) Versus NRT Alone on Craving Related to Smoking Cessation in Students.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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