Clinical Research Directory

Effects of Different 432 Hz Auditory Stimuli on Physiological Stress Responses and Patient Satisfaction in Adults With Dental Anxiety During Restorative Treatment

In this four-arm randomized controlled clinical trial, 120 adults aged 18-50 years with baseline Modified Dental Anxiety Scale scores ≥13 were allocated equally to 432 Hz-based instrumental music, water sounds, human-vocal music, or a no-audio control during standardized restorative cavity preparation. Heart rate, systolic and diastolic blood pressure, peripheral oxygen saturation, and body temperature were recorded before and immediately after preparation; patient satisfaction was assessed after restoration. Physiological outcomes were compared using baseline-adjusted analysis of covariance, with Holm-adjusted pairwise comparisons. The null hypothesis was that there would be no significant differences among the four study groups in changes in physiological parameters or post-treatment patient satisfaction. The alternative hypothesis was that at least one auditory intervention condition would differ from the other study conditions in physiological responses and/or patient satisfaction.

Effect of Passive Music Therapy Via an App on Anxiety Prevention in ENT Surgery

Music therapy is a controlled method of listening to music, utilizing its physiological, psychological, and emotional effects on humans during the treatment of illness or trauma. It is considered active when it involves playing musical instruments and passive when it involves listening to music (via headphones, television, stereo systems, etc.). The benefits of this technique in treating chronic pain (i.e., pain lasting several weeks, such as chronic back pain, osteoarthritis, etc.) have been demonstrated. Numerous studies have also examined the effect of music therapy on acute postoperative pain and anxiety related to surgical interventions. These studies suggest, though without conclusive evidence, that a single session of music therapy just before entering the operating room may reduce postoperative pain and anxiety. However, all of these studies were limited by relatively small sample sizes (a few hundred patients), leaving some scientific uncertainty regarding the effectiveness of music therapy in the context of surgical interventions. This research will therefore evaluate the impact of preoperative passive music therapy on perioperative anxiety and postoperative pain, with a larger number of patients included in the study than has been previously reported in the scientific literature. The primary objective of this study is to assess the impact of preoperative passive music therapy on perioperative anxiety in patients undergoing ENT surgery. MUSICORL is an interventional, randomized study (the assignment to receive or not receive music therapy will be determined by randomization) with two parallel arms. This is a single-center study, conducted at a single French site: Clinique Saint Vincent. A total of 500 subjects will participate in this study. Your participation will last for 2 days; the overall study duration will be 27 months. To participate in this research, you must be affiliated with a social security system, be over 18 years old, have signed informed consent, and be scheduled for ENT surgery (cervical, endonasal, otologic, oropharyngeal-laryngeal).