Clinical trial NCT05417529: Preoperative Music Listening in Odontostomatological Surgery (PMLOS)
Official title: Preoperative Music Listening Versus Intravenous Midazolam (PMLOS) on Anxiety, Sedation and Stress in Odontostomatological Surgery: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage I or II Micro-invasive Oral Cancer
Keywords: music therapy
stress
sedation
surgery
anesthesia
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Anxiety
timeFrame: 30 minutes before
measure: Anxiety
timeFrame: 60 minutes after
measure: Bispectral Index (BIS)
timeFrame: during anesthesia induction
measure: Patient global impression of satisfaction (PGIS)
timeFrame: through study completion, 1 hour after surgery
Secondary outcomes:
measure: Blood Pressure (SBP-DPB)
timeFrame: during the procedure
measure: Heart Rate
timeFrame: during the procedure
measure: O2SAT
timeFrame: during the procedure
Other outcomes:
Locations:
city: Bari
country: Italy
facility: AOUC Policlinico di Bari
Study officials:
affiliation: University of Bari
name: Filomena Puntillo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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