Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657040
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Music for Surgical Intensive Care MUSIC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Music for Surgical Intensive Care MUSIC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUSIC
Brief Summary:
Intensive care units ICUs are environments specialized in the care of critically ill patients Despite significant advances ICUs are often seen as a dehumanized environment Among the various stressors in ICUs anxiety pain psychomotor agitation and mental confusion need for mechanical restraint lack of privacy noise restricted visiting time with family members and excessive lighting stand out The tripod composed of pain anxiety and delirium often associated with the presence of psychomotor agitation mental confusion and altered level of consciousness has a high incidence and morbidity A set of prevention intensity reduction and treatment measures has been proposed for these conditions with a growing number of scientific evidence supporting their routine use
Elderly patients tend to be particularly susceptible to the stressors described above This aspect represents an additional source of concern for ICUs since the elderly today represent the majority of patients admitted to ICUs Hospitalization in ICUs after surgical procedures is often an unknown moment for the individual and consequently associated with the development of numerous unpleasant sensations directly interfering with the patients recovery
Music as a therapy tool in medical practice has been used since 1890 After a little more than two decades in 1914 it was applied in a surgical procedure by physician Evan Kane as a way of calming patients and diverting attention from fear associated with combined therapy with local anesthesia In this context being a low-cost tool with minimal adverse effects and high acceptability the use of music has proven to be a great ally in the arsenal of non-pharmacological therapies for the prevention of delirium anxiety and pain
We intend through a randomized multicenter clinical trial to investigate whether the use of music as therapy is capable of reducing the incidence of anxiety pain and delirium in elderly patients undergoing surgical procedures and hospitalized during the postoperative period in intensive care units
Elderly patients tend to be particularly susceptible to the stressors described above This aspect represents an additional source of concern for ICUs since the elderly today represent the majority of patients admitted to ICUs Hospitalization in ICUs after surgical procedures is often an unknown moment for the individual and consequently associated with the development of numerous unpleasant sensations directly interfering with the patients recovery
Music as a therapy tool in medical practice has been used since 1890 After a little more than two decades in 1914 it was applied in a surgical procedure by physician Evan Kane as a way of calming patients and diverting attention from fear associated with combined therapy with local anesthesia In this context being a low-cost tool with minimal adverse effects and high acceptability the use of music has proven to be a great ally in the arsenal of non-pharmacological therapies for the prevention of delirium anxiety and pain
We intend through a randomized multicenter clinical trial to investigate whether the use of music as therapy is capable of reducing the incidence of anxiety pain and delirium in elderly patients undergoing surgical procedures and hospitalized during the postoperative period in intensive care units
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None