Ignite Creation Date:
2024-05-06 @ 4:31 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05015985
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-03
First Post:
2021-04-24
Brief Title:
MUSIC-CARE and Locoregional Anesthesia for Orthopedic Surgery
Sponsor:
American Hospital of Paris
Organization:
American Hospital of Paris
Study Overview
Official Title:
Benefits of a Music-based Self-relaxing Program Application MUSIC-CARE Combined to Locoregional Anesthesia for Forearm Orthopedic Surgery A Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
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:
None
Brief Summary:
Anxiety fright stress and pain have always been sources of emotional distress for patients undergoing invasive procedures in clinical settings Experts have long used traditional methods such as analgesics and anxiolytics to address these issues But backed by a movement aiming at reducing the use of pharmacological products alternative interventions including music therapy have gained some steam in recent years These interventions may have the ability to reduce pain and anxiety while increasing relaxation coping skills and the overall experience of the procedure For orthopedic surgery anesthetics could propose general anesthesia or locoregional anesthesia The upper limb orthopedic surgery is often performed under locoregional anesthesia and in the ambulatory procedure However with the known exacerbating effects of stress and anxiety on pain the affective experience of the patient can be negatively influenced In order to mitigate these problems various types of sedatives and anxiolytics and even low-dose propofol can be used
The Montpellier Regional University Hospital along with the Music Care Company developed a software so as to standardize this technique around these recommendations This model demonstrated its efficacy in both acute and chronic pain settings Indeed a single music therapy session was found to be effective for decreasing anxiety and promoting relaxation as indicated by decreases in heart rate blood pressure BIS and respiratory rate over the intervention period in intubated patients during weaning phase Also a patient-controlled music intervention administered by Music Care has shown to alleviate negative psychological eg depression and physiological eg pain and discomfort outcomes and very importantly to reduce the consumption of medication in patients with chronic pain due to lumbar pain fibromyalgia inflammatory or neurological diseases
Given the recent availability of a standardized and proven delivery method of music therapy ie MUSIC-CARE the principal aim of this randomized clinical trial is to assess the effect of this music therapy program delivered by application compared to usual playlist music on drug consumptions and physiological parameters pain anxiety levels in patients undergoing forearm orthopedic surgery under locoregional anesthesia
The Montpellier Regional University Hospital along with the Music Care Company developed a software so as to standardize this technique around these recommendations This model demonstrated its efficacy in both acute and chronic pain settings Indeed a single music therapy session was found to be effective for decreasing anxiety and promoting relaxation as indicated by decreases in heart rate blood pressure BIS and respiratory rate over the intervention period in intubated patients during weaning phase Also a patient-controlled music intervention administered by Music Care has shown to alleviate negative psychological eg depression and physiological eg pain and discomfort outcomes and very importantly to reduce the consumption of medication in patients with chronic pain due to lumbar pain fibromyalgia inflammatory or neurological diseases
Given the recent availability of a standardized and proven delivery method of music therapy ie MUSIC-CARE the principal aim of this randomized clinical trial is to assess the effect of this music therapy program delivered by application compared to usual playlist music on drug consumptions and physiological parameters pain anxiety levels in patients undergoing forearm orthopedic surgery under locoregional anesthesia
Detailed Description:
This is a randomized controlled clinical study on patients who were followed during their forearm orthopedic surgery The research has been submitted and approved by the Institutional review Board IRB at the American Hospital of Paris Before their inclusion in the study after to give their consentment patients were verbally given details about the methods and techniques of the music session
Patients scheduled to undergo forearm orthopedic surgery SR under regional anesthesia are recruited in this study They are assigned to one of 2 groups in a randomized manner Excluding criteria are age less 18 years or up 80 years patients who do not like music for cultural reason having serious psychiatric disorder or with not paired deafness or paired one with devices that were incompatible with wearing a headset After randomization patients are placed in the control group using a music support from playlist or assigned to the MUSICARE group
In both group after per os hydroxyzine premedication each patient received a regional anesthesia using mepivacaine 2 at least 20 minutes before skin incision under tourniquet The regional anesthesia is performed using either an axillary plexus block or mild-arm trunk nerve block with electrical nerve stimulation and ultrasound nerve localization The music support is started before to do the regional anesthesia and continued during all the orthopedic procedure According to the anxiety level and patient request an intravenous titration of midazolam was infused 1 mg per 1 mg to get a sedative score less or equal to 1 If this target is not met after 3 mg of midazolam the anesthetist could infuse a low dose of propofol 20 mg
During all the procedure the anesthetist performing the regional anesthesia and the intravenous hypnotic administration is blinded about the patient group and musicThe Music-Care app is a receptive music intervention allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music All musical pieces were recorded in high-quality recording studios with professional musicians
Music-Care utilizes the U technique designed to gradually relax the listener In the current study music sequences during patients sessions were based on the mount U and instrumental musical works were selected for a varying numbers styles classical jazz world music etc and adapted to the patients style via patient request The U technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each Initially the objective is to represent the patients state of tension by stimulating musical rhythm of 80-95 beats per minute bpm From there the remaining 4 sub-pieces are presented in a blended fashion in an attempt for the patient to gradually fall into a relaxed state via a gradual reduction in musical tempo 40-80 bpm orchestral size frequencies and volume descending arm of the U The music session then reaches a phase of maximum relaxation downward phase of the U before a phase that gradually returns to baseline dynamics ascending arm of the U
In the control group a music program from an established playlist with various instrumental music is chosen by the patient and delivered by the same tablet
program The primary study end points were the consumptions in sedatives midazolam and propofol from 10 minutes prior to the procedure until its end Secondary study end points were pain and anxiety scores as measured the Numeric Rating Scale NRS and the Amsterdam Preoperative Anxiety and Information Scale APAIS collected before and right after the end of the procedure in the recovery room We also evaluated the physiological parameters such as sedation score 0 awake 1 unconsciousness but reactive to verbal stimulation 2 unconsciousness but reactive to nociceptive stimulation 3 areactive to stimulation heart rate arterial blood pressure oxygen saturation at different time points between T0 10 minutes prior to the beginning of the procedure and T45 45 minutes after it Satisfaction was also collected using a scale from 0 to 5 with a higher score for a high satisfaction right after the end of the procedure in the recovery room
Patients scheduled to undergo forearm orthopedic surgery SR under regional anesthesia are recruited in this study They are assigned to one of 2 groups in a randomized manner Excluding criteria are age less 18 years or up 80 years patients who do not like music for cultural reason having serious psychiatric disorder or with not paired deafness or paired one with devices that were incompatible with wearing a headset After randomization patients are placed in the control group using a music support from playlist or assigned to the MUSICARE group
In both group after per os hydroxyzine premedication each patient received a regional anesthesia using mepivacaine 2 at least 20 minutes before skin incision under tourniquet The regional anesthesia is performed using either an axillary plexus block or mild-arm trunk nerve block with electrical nerve stimulation and ultrasound nerve localization The music support is started before to do the regional anesthesia and continued during all the orthopedic procedure According to the anxiety level and patient request an intravenous titration of midazolam was infused 1 mg per 1 mg to get a sedative score less or equal to 1 If this target is not met after 3 mg of midazolam the anesthetist could infuse a low dose of propofol 20 mg
During all the procedure the anesthetist performing the regional anesthesia and the intravenous hypnotic administration is blinded about the patient group and musicThe Music-Care app is a receptive music intervention allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music All musical pieces were recorded in high-quality recording studios with professional musicians
Music-Care utilizes the U technique designed to gradually relax the listener In the current study music sequences during patients sessions were based on the mount U and instrumental musical works were selected for a varying numbers styles classical jazz world music etc and adapted to the patients style via patient request The U technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each Initially the objective is to represent the patients state of tension by stimulating musical rhythm of 80-95 beats per minute bpm From there the remaining 4 sub-pieces are presented in a blended fashion in an attempt for the patient to gradually fall into a relaxed state via a gradual reduction in musical tempo 40-80 bpm orchestral size frequencies and volume descending arm of the U The music session then reaches a phase of maximum relaxation downward phase of the U before a phase that gradually returns to baseline dynamics ascending arm of the U
In the control group a music program from an established playlist with various instrumental music is chosen by the patient and delivered by the same tablet
program The primary study end points were the consumptions in sedatives midazolam and propofol from 10 minutes prior to the procedure until its end Secondary study end points were pain and anxiety scores as measured the Numeric Rating Scale NRS and the Amsterdam Preoperative Anxiety and Information Scale APAIS collected before and right after the end of the procedure in the recovery room We also evaluated the physiological parameters such as sedation score 0 awake 1 unconsciousness but reactive to verbal stimulation 2 unconsciousness but reactive to nociceptive stimulation 3 areactive to stimulation heart rate arterial blood pressure oxygen saturation at different time points between T0 10 minutes prior to the beginning of the procedure and T45 45 minutes after it Satisfaction was also collected using a scale from 0 to 5 with a higher score for a high satisfaction right after the end of the procedure in the recovery room
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