Clinical trial

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.

Name
MUSMOKHEALTH
Description
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.
Trial arms
Trial start
2024-02-28
Estimated PCD
2025-01-10
Trial end
2026-01-10
Status
Recruiting
Treatment
Music intervention
Music therapy carried out with Music Care
Arms:
Music intervention and NRT
Nicotine replacement
NRT: Nicotine Patch, Nicotine Gum
Arms:
Music intervention and NRT, NRT Group
Size
50
Primary endpoint
Assess if Music therapy associated to NRT decrease tabacco craving compared to NRT alone
Month 1
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-03-01

1 organization

2 products

1 indication

Product
Nicotine