Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600919
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Effect of Passive Music Therapy Via an App on Anxiety Prevention in ENT Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Passive Music Therapy Via an App on Anxiety Prevention in ENT Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
MUSICORL
Brief Summary:
Music therapy is a controlled method of listening to music utilizing its physiological psychological and emotional effects on humans during the treatment of illness or trauma It is considered active when it involves playing musical instruments and passive when it involves listening to music via headphones television stereo systems etc
The benefits of this technique in treating chronic pain ie pain lasting several weeks such as chronic back pain osteoarthritis etc have been demonstrated Numerous studies have also examined the effect of music therapy on acute postoperative pain and anxiety related to surgical interventions These studies suggest though without conclusive evidence that a single session of music therapy just before entering the operating room may reduce postoperative pain and anxiety
However all of these studies were limited by relatively small sample sizes a few hundred patients leaving some scientific uncertainty regarding the effectiveness of music therapy in the context of surgical interventions
This research will therefore evaluate the impact of preoperative passive music therapy on perioperative anxiety and postoperative pain with a larger number of patients included in the study than has been previously reported in the scientific literature
The primary objective of this study is to assess the impact of preoperative passive music therapy on perioperative anxiety in patients undergoing ENT surgery MUSICORL is an interventional randomized study the assignment to receive or not receive music therapy will be determined by randomization with two parallel arms This is a single-center study conducted at a single French site Clinique Saint Vincent A total of 500 subjects will participate in this study Your participation will last for 2 days the overall study duration will be 27 months
To participate in this research you must be affiliated with a social security system be over 18 years old have signed informed consent and be scheduled for ENT surgery cervical endonasal otologic oropharyngeal-laryngeal
The benefits of this technique in treating chronic pain ie pain lasting several weeks such as chronic back pain osteoarthritis etc have been demonstrated Numerous studies have also examined the effect of music therapy on acute postoperative pain and anxiety related to surgical interventions These studies suggest though without conclusive evidence that a single session of music therapy just before entering the operating room may reduce postoperative pain and anxiety
However all of these studies were limited by relatively small sample sizes a few hundred patients leaving some scientific uncertainty regarding the effectiveness of music therapy in the context of surgical interventions
This research will therefore evaluate the impact of preoperative passive music therapy on perioperative anxiety and postoperative pain with a larger number of patients included in the study than has been previously reported in the scientific literature
The primary objective of this study is to assess the impact of preoperative passive music therapy on perioperative anxiety in patients undergoing ENT surgery MUSICORL is an interventional randomized study the assignment to receive or not receive music therapy will be determined by randomization with two parallel arms This is a single-center study conducted at a single French site Clinique Saint Vincent A total of 500 subjects will participate in this study Your participation will last for 2 days the overall study duration will be 27 months
To participate in this research you must be affiliated with a social security system be over 18 years old have signed informed consent and be scheduled for ENT surgery cervical endonasal otologic oropharyngeal-laryngeal
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