Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461052
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-24
Brief Title:
Information and Music Therapy as a Means of Reducing Preoperative Anxiety in Outpatient Surgery
Sponsor:
Hopital Foch
Organization:
Hopital Foch
Study Overview
Official Title:
Information and Music Therapy as a Means of Reducing Preoperative Anxiety in Outpatient Surgery Outpatient Surgery a Before-and-after Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Harmonie
Brief Summary:
This is a monocentric prospective before-and-after open-label controlled study two groups of 99 patients each control group - usual care - versus intervention group Intervention group - patient information via an explanatory video followed by a 15-minute music therapy session of the patients choice in the operating waiting room
Detailed Description:
Although general anaesthesia is used for almost 10 million procedures a year and the safety of this procedure has improved considerably over the last 25 years notably with the safety decree of December 1994 general anaesthesia remains deeply associated with high levels of preoperative anxiety Anxiety levels are correlated with two perioperative factors
the need for more anesthetic agents to achieve the same level of depth of anesthesia in anxious patients compared to non-anxiouslow-anxiety patients
Development of chronic postoperative pain
The preoperative consultation and visit by an anaesthetist is an important meeting point to reduce these high levels of anxiety On the other hand systematic benzodiazepine-based premedication has been abandoned for some years now and taking action to reduce the level of anxiety is one of todays challenges using a variety of means organizational video music virtual reality hypnosis
Unfortunately the level of publication on the subject remains low
Currently a local analysis of this pathway shows several waiting times for which patients are not necessarily informed and which can generate anxiety during treatment In addition our preliminary survey on the subject showed a specific need for information on pain management and anaesthesia recovery and anesthesia recovery
The goal of this study was to design a two-group comparative study aiming of significantly reducing perioperative anxiety in outpatients by implementing simple solutions More specifically our project focuses on the impact of music therapy and dedicated information via an explanatory video of the patients journey through the operating room on the level of perioperative anxiety
the need for more anesthetic agents to achieve the same level of depth of anesthesia in anxious patients compared to non-anxiouslow-anxiety patients
Development of chronic postoperative pain
The preoperative consultation and visit by an anaesthetist is an important meeting point to reduce these high levels of anxiety On the other hand systematic benzodiazepine-based premedication has been abandoned for some years now and taking action to reduce the level of anxiety is one of todays challenges using a variety of means organizational video music virtual reality hypnosis
Unfortunately the level of publication on the subject remains low
Currently a local analysis of this pathway shows several waiting times for which patients are not necessarily informed and which can generate anxiety during treatment In addition our preliminary survey on the subject showed a specific need for information on pain management and anaesthesia recovery and anesthesia recovery
The goal of this study was to design a two-group comparative study aiming of significantly reducing perioperative anxiety in outpatients by implementing simple solutions More specifically our project focuses on the impact of music therapy and dedicated information via an explanatory video of the patients journey through the operating room on the level of perioperative anxiety
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02493-42 | REGISTRY | ID-RCB number | None |