NCT06130423

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 28, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

March 1, 2024

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

November 8, 2023

Last Update Submit

February 28, 2024

Conditions

Smoking Cessation

Keywords

PreventionMusic TherapyCraving

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Test the feasibility of such a program in smoking cessation

    Month 3

  • Evaluate the evolution of tabacco craving

    Month [2;3]

  • Evaluate the evolution of Anxiety

    Month [1;2;3]

  • Evaluate the evolution of nicotine withdrawal symptoms

    Month [1;2;3]

  • Evaluate the evolution of impulsivity

    Month [1;2;3]

  • +3 more secondary outcomes

Study Arms (2)

Music intervention and NRT

EXPERIMENTAL

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 interventionDrug: Nicotine replacement

NRT Group

ACTIVE COMPARATOR

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

Interventions

Music interventionDRUG

Music therapy carried out with Music Care

Music intervention and NRT
Nicotine replacementDRUG

NRT: Nicotine Patch, Nicotine Gum

Music intervention and NRTNRT Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Poitiers / CIC

Poitiers, France

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Central Study Contacts

Claire LAFAY-CHEBASSIER, Dr

CONTACT

05 49 44 38 36claire.lafay-chebassier@chu-poitiers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 14, 2023

Study Start

February 28, 2024

Primary Completion

January 10, 2025

Study Completion

January 10, 2026

Last Updated

March 1, 2024

Record last verified: 2023-09

Locations

FR(1)