Preoperative Music Listening in Odontostomatological Surgery (PMLOS)

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.

Conditions

• Stage I or II Micro-invasive Oral Cancer

Interventions

OTHER

music therapy intervention

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

DRUG

Standard Preparation

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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

  lead OTHER

Principal Investigators

• Filomena Puntillo, PhD · University of Bari

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-01

Primary Completion

2020-03-15

Completion

2021-03-15

Countries

• Italy

Study Locations