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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Nicotine replacement; Drug: Music intervention

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)).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire LAFAY-CHEBASSIER, Dr; Phone Number: +33 05 49 44 38 36; Email: claire.lafay-chebassier@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France
    • Recruiting
    • CHU Poitiers / CIC
    • Contact: Christophe RAULT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Nicotine replacement; NRT: Nicotine Patch, Nicotine Gum; Drug: Music intervention; Music therapy carried out with Music Care
Active Comparator: 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.	Drug: Nicotine replacement; NRT: Nicotine Patch, Nicotine Gum

What is the study measuring?

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
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 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]
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 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]

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Estimated): January 10, 2025
• Study Completion (Estimated): January 10, 2026

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Prevention; Craving; Music Therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: MUSMOKHEALTH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No