Preoperative Music Listening in Odontostomatological Surgery (PMLOS) (PMLOS)

June 9, 2022 updated by: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • AOUC Policlinico di Bari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatement Group
Participants received music therapy intervention
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
Active Comparator: Control Group
Patients in control group receive premedication
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 30 minutes before
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
Time Frame: 60 minutes after
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)
Time Frame: during anesthesia induction

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)
Time Frame: through study completion, 1 hour after surgery
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
Time Frame
Blood Pressure (SBP-DPB)
Time Frame: during the procedure
during the procedure
Heart Rate
Time Frame: during the procedure
during the procedure
O2SAT
Time Frame: during the procedure
during the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Investigators

  • Principal Investigator: Filomena Puntillo, PhD, University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

March 15, 2020

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (Actual)

June 14, 2022

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTI.ODONTO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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