Clinical trial NCT05015985: MUSIC-CARE and Locoregional Anesthesia for Orthopedic Surgery
Official title: Benefits of a Music-based Self-relaxing Program Application (MUSIC-CARE) Combined to Locoregional Anesthesia for Forearm Orthopedic Surgery : A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Regional Anesthesia
Music
Forearm; Injury, Superficial, Multiple (With Elbow)
Keywords: musicotherapy,
anxiety
pain
locoregional anesthesia
orthopedic surgery
Musicare
Lead sponsor: American Hospital of Paris
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, the investigators compare a specific program of music therapy to an usual music support by playlist. The specific program MUSIC-CARE is administered through a hardware and software, consisting of a modern tablet. The 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. Initially, the objective is to represent the patient's state of tension by stimulating musical rhythm of 80-95 beats per minute (bpm). Then, it gradually falls into a relaxed state via a gradual reduction in musical tempo (40-80 bpm), orchestral size, frequencies, and volume (descending arm of the "U").
Primary purpose: SUPPORTIVE_CARE

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 (e.g., depression) and physiological (e.g., 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 (i.e. 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 patient's 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 patient's 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.

Eligibility criteria: Inclusion Criteria:

* scheduled forearm orthopedic surgery
* locoregional anesthesia

Exclusion Criteria:

* age below 18 yrs or up to 80 yrs
* emergency
* surgery duration up to 90 minutes
* patient refusing locoregional anesthesia
* local contreindication to locoregional anesthesia
* patients who do not like music for cultural reason,
* patients having serious psychiatric disorder or cognitive disease
* patients with not paired deafness or paired one with devices that were incompatible with wearing a headset.

Primary outcomes:
measure: sedative requirement
timeFrame: during the intraoperative period
Secondary outcomes:
measure: anxiety score change
timeFrame: during the intraoperative period
measure: pain score change
timeFrame: during the intraoperative period
measure: sedation score change
timeFrame: during the intraoperative period
measure: satisfaction score
timeFrame: in postoperative period
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: American Hospital of Paris
Study officials:
affiliation: American Hospital of Paris
name: Gilles BOCCARA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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