Clinical Research Directory

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).

Prediction Model for Postoperative Headache After Transsphenoidal Pituitary Surgery

Primary Objective: This observational study aims to construct a predictive model for short-term headache following endonasal pituitary adenoma surgery and to identify risk factors associated with postoperative headache after endonasal surgery. Secondary Objectives: First, to investigate the relationship between the severity of short-term postoperative headache and long-term life burden (at 1 and 3 months postoperatively), as well as its correlation with quality of life. Second, to elucidate the clinical characteristics and evolutionary patterns of short-term postoperative headache. Third, to explore key aspects of perioperative management, including changes in nasal cavity status and postoperative mobilization, which may optimize the management of short-term postoperative headache. Primary outcome measure1: VAS scale（0-10） Primary outcome measure2: feature of postoperative headache including (location, type, length, accompany symptom, and factors that elevate or sharpen headache, analgesics usage, analgesics frequency, analgesics effect) Secondary outcome measure 1: HIT-6 test Secondary outcome measure 2: Postoperative Olfaction Secondary outcome measure 3: Postoperative Massive Epistaxis Participants will undergo daily assessments postoperatively, which include evaluations of headache, nasal cavity status, and analgesic drug usage. These assessments will continue until two consecutive Visual Analog Scale (VAS) scores are less than 4. Additionally, participants will complete questionnaires, including the Headache Impact (HIT-6) test at 4 weeks and 12 weeks postoperatively.