Preoperative Music Listening in Odontostomatological Surgery (PMLOS)

Study Overview
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Brief Summary
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People undergoing general anesthesia for oral cancer diagnosis and treatment often experience heightened anxiety, fear and stress with negative bodily responses, such as tachycardia, hypertension, increased myocardial consumption of O2, arrhythmias, increased peripheral resistance, hypercoagulability, immunodeficiency and catabolic response . Emotional distress and pain may be managed by pre-procedurally application of anxiolytic, analgesic, and anesthetic drugs, but with potential risks or side effects such as respiratory depression, nausea and vomiting, confusion, memory loss, hypoxemia, and drug-drug interactions. This may result in adverse outcomes, such as delayed healing, increased healthcare utilization, and cost. A recent Cochrane review showed that benzodiazepines reduce pre-procedural anxiety compared with placebo with a low quality of evidence. Music therapy (MT), defined as the clinical and evidence-based use of music interventions by a trained professional for the purpose of achieving individualized goals within a therapeutic relationship between patient, music and music therapist 6 , may be used as a safe and cost-effective complementary intervention in adjunct to standard surgical care. During surgery, music is a powerful positive stimulus that evokes and modulates emotions as well as mood, face mask adverse stimuli, and improves emotional health through coping. Music therapy and music medicine interventions are effective to prevent and treat emotional distress and pain before, during and after medical procedures . Evidence from Cochrane systematic reviews shows that music interventions affect positively anxiety in patients with cancer, coronary heart diseases and in patients on mechanical ventilation . Some studies reported also that music interventions reduced sedative requirements in patients undergoing surgery under regional anesthesia combined with sedation, both with midazolam and propofol and also in critically ill patients in intensive care units. The primary aim of this study was to evaluate the effects of preoperative music therapy intervention compared to premedication with midazolam on anxiety, sedation and stress during general anesthesia for odontostomatological elective surgery.

Official Title
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Preoperative Music Listening Versus Intravenous Midazolam (PMLOS) on Anxiety, Sedation and Stress in Odontostomatological Surgery: a Randomized Controlled Study

Conditions
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Stage I or II Micro-invasive Oral Cancer

Intervention / Treatment
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* Other: music therapy intervention
* Drug: Standard Preparation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years no severe neurological or psychiatric conditions, no hearing impairment, no drugs abuse, American Society of Anesthesiologists (ASA) score I to III Exclusion Criteria: < 18 years severe neurological or psychiatric conditions, hearing impairment, drugs abuse, American Society of Anesthesiologists (ASA) score IV to V

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatement Group<br>Participants received music therapy intervention | Other: music therapy intervention<br>* Participants did not receive premedication with midazolam 0,02 mg/kg intravenous and received music therapy intervention by a certified music therapist FAMI . Music Treatment consisted of 3 steps: (1)30 minutes before surgery, music therapist (MTp) engaged the patient in an individual brief conversation (10 min.) to identify preferred musical genre/songs and prepared a customized playlists to listen to during induction; (2)After being monitored in the operating room, patients were prepared to listening to music ; (3)Music listening during anesthesia induction. Anesthesia was the same in both groups. Induction was carried out by fentanyl 3mcg/kg, propofol 2 mg/kg and rocuronium at the dose of 1mg/kg to facilitate intubation<br>|
| Active Comparator: Control Group<br>Patients in control group receive premedication | Drug: Standard Preparation<br>* Partecipants receive premedication with midazolam 0,02 mg/kg intravenous. Anesthesia was the same in both groups. Induction was carried out by fentanyl 3mcg/kg, propofol 2 mg/kg and rocuronium at the dose of 1mg/kg to facilitate intubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Anxiety Visual Analogues Scale (A-VAS) was used to evaluate the level of anxiety from 0 (no anxiety) to 10 (maximum anxiety) before surgical procedure T0 | 30 minutes before | 
| Anxiety | Anxiety Visual Analogues Scale (A-VAS) was used to evaluate the level of anxiety from 0 (no anxiety) to 10 (maximum anxiety) before surgical procedure T0 | 60 minutes after | 
| Bispectral Index (BIS) | Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia. BIS monitors are used to supplement Guedel's classification system for determining depth of anesthesia. Titrating anesthetic agents to a specific bispectral index during general anesthesia in adults (and children over 1 year old) allows the anesthetist to adjust the amount of anesthetic agent to the needs of the patient, possibly resulting in a more rapid emergence from anesthesia. BIS monitoring is widely used in clinical anesthesia as an index for monitoring the electrical activity of the cerebral cortex and the sedative ingredients of anesthesia. BIS scores range from 0 to 100 (0, coma; 40-60, general anesthesia; 60-90, sedated; 100, awake) and reflect the level of sedation regardless of a patient's clinical characteristics or the type of sedative drug used. | during anesthesia induction | 
| Patient global impression of satisfaction (PGIS) | Patient global impression of satisfaction (PGIS) with a 4 items score ( 1=very dissatisfied, 2=dissatisfied, 3=satisfied, 4=very satisfied). | through study completion, 1 hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure (SBP-DPB) |  | during the procedure | 
| Heart Rate |  | during the procedure | 
| O2SAT |  | during the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music therapy, stress, sedation, surgery, anesthesia