NCT06130423

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Music intervention	Music therapy carried out with Music Care
DRUG	Nicotine replacement	NRT: Nicotine Patch, Nicotine Gum

Timeline

• Start date: 2024-02-28
• Primary completion: 2025-01-10
• Completion: 2026-01-10
• First posted: 2023-11-14
• Last updated: 2024-03-01

Locations

1 site across 1 country: France