Study to Evaluate Music Therapy and Nicotine Replacement Therapy on Craving Related to Smoking Cessation in Health Staff

Study Overview
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Brief Summary
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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 50 health staff smokers. This pilot multi-method study will combine the methodology of clinical trial with qualitative techniques used in social sciences to show the interest of a digital music therapy tool, adapted to a health staff audience.

Detailed Description
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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 Target Quit Date (TQD) , 3 visits will be performed by practitioners and nurses at the CIC. They will register smoking status of the participant, exhaled carbon monoxide concentration, body weight and all adverse events. Participants will answer questionnaires (FTCQ-12,Hospital Anxiety and Depression Scale ( HAD), Minnesota Nicotine Withdrawal Scale (MNWS), Impulsive Behavior Scale (UPPS), State-trait Anxiety Inventory Forme Y (STAI-Y)).

Official Title
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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 Health Staff.

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Music intervention
* Drug: Nicotine replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Health staff, Age >= 18 years Smoking more than 10 cigarettes per day for at least 6 months motivated to quit smoking without legal tutors or subordination affiliated to a health insurance system as required by the French law on biomedical research written informed consent for participation in the study Exclusion Criteria: Roommates and couples NRT contraindication unstabilised depression psychosis and/or cognitive disorder and/or mental retardation substance misuse or alcohol dependence smoking-cessation medication (NRT, bupropion) or undergoing cognitive-behavioral therapy or hypnotherapy for smoking cessation in the last 3 months electronic cigarette for smoking cessation in the last 3 months participating in a study up to visit 4 Persons benefiting from enhanced protection, i.e.persons deprived of their liberty by a judicial or administrative decision, adults under legal and finally patients in a vital emergency situation.

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music intervention and NRT<br>The rhythm of the music sessions will be 2 per week in the first month, 1 per week in the second month and 1 every 15 days in th third month, music intervention will be associated to NRT. | Drug: Music intervention<br>* Music therapy carried out with Music Care<br>Drug: Nicotine replacement<br>* NRT: Nicotine Patch, Nicotine Gum<br>|
| Active Comparator: NRT Group<br>Nicotine Patch, Nicotine Gum as in the intervention group, the physician will adapt the type of NRT according to the patient's smoking profile. | Drug: Nicotine replacement<br>* NRT: Nicotine Patch, Nicotine Gum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess if Music therapy associated to NRT decrease tabacco craving compared to NRT alone | 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 | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test the feasibility of such a program in smoking cessation | Music therapy sessions compliance. Number and reasons for non attending music therapy sessions | Month 3 | 
| Evaluate the evolution of tabacco craving | 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 | Month [2;3] | 
| Evaluate the evolution of Anxiety | HAD (Hospital Anxiety and Depression Scale) score. Maximum score for each score (total A, total D) =21. Score over 10 definite state of anxiety. Lower scores mean a better outcome | Month [1;2;3] | 
| Evaluate the evolution of nicotine withdrawal symptoms | 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. | Month [1;2;3] | 
| Evaluate the evolution of impulsivity | 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. | Month [1;2;3] | 
| Evaluate the efficacy of the intervention on smoking cessation | Self reported abstinence or smoking reduction > or = 50% | Month [1;2;3] | 
| Evaluate the efficacy of the intervention on smoking cessation | Self reported abstinence or smoking reduction > or = 50% | Month [6;12] | 
| Evaluate the evolution of Anxiety | STAI-Y (Form-Y of the State-Trait Anxiety Inventory) score. It consist of two 20-item scales providing separate measures of state and trait anxiety (S-Anxiety and T-Anxiety, respectively). On a 4-point Likert scale (1-4), a score equal to 4 indicates the presence of a higher level of anxiety. | Month [1;2;3] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Music Therapy, Craving