Ignite Creation Date:
2024-05-06 @ 5:44 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05417529
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2022-06-01
Brief Title:
Preoperative Music Listening in Odontostomatological Surgery PMLOS
Sponsor:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Organization:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Study Overview
Official Title:
Preoperative Music Listening Versus Intravenous Midazolam PMLOS on Anxiety Sedation and Stress in Odontostomatological Surgery a Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PMLOS
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None