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

NCT ID: NCT06130423

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-28
• Study Completion Date: 2026-01-10

Brief Summary

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

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)).

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Music intervention and NRT

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.

Group Type: EXPERIMENTAL

Music intervention

Intervention Type: DRUG

Music therapy carried out with Music Care

Nicotine replacement

Intervention Type: DRUG

NRT: Nicotine Patch, Nicotine Gum

NRT Group

Nicotine Patch, Nicotine Gum as in the intervention group, the physician will adapt the type of NRT according to the patient's smoking profile.

Group Type: ACTIVE_COMPARATOR

Nicotine replacement

Intervention Type: DRUG

NRT: Nicotine Patch, Nicotine Gum

Interventions

Music intervention

Music therapy carried out with Music Care

Intervention Type: DRUG

Nicotine replacement

NRT: Nicotine Patch, Nicotine Gum

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Poitiers / CIC

Poitiers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Claire LAFAY-CHEBASSIER, Dr

Role: CONTACT

claire.lafay-chebassier@chu-poitiers.fr

05 49 44 38 36 ext. +33

Facility Contacts

Christophe RAULT

Role: primary

Other Identifiers

MUSMOKHEALTH

Identifier Type: -

Identifier Source: org_study_id