MUSIC-CARE and Locoregional Anesthesia for Orthopedic Surgery

NCT05015985 | Unknown

• 1 other identifier: MUSICARE/ALR/ORTHO1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia; Music; Forearm; Injury, Superficial, Multiple (With Elbow)

Keywords

musicotherapy,; anxiety; pain; locoregional anesthesia; orthopedic surgery; Musicare

Outcome Measures

Primary Outcomes (1)

• sedative requirement

  midazolam and/or propofol peroperative consumption in milligramme

  during the intraoperative period

Secondary Outcomes (4)

• anxiety score change

  during the intraoperative period

• pain score change

  during the intraoperative period

• sedation score change

  during the intraoperative period

• satisfaction score

  in postoperative period

Study Arms (2)

MUSIC-CARE Group

ACTIVE COMPARATOR

In the Music-Care group, a program of music therapy was administered through a hardware and software provided to the investigative team by the Music-Care Company. The standardized techniques include three sequences in which the relaxing, maintenance and simulating times differ. 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.

Other: Music-Care

CONTROL group

SHAM COMPARATOR

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.

Other: control group

Interventions

Music-Care OTHER

music relaxation by a specific hardware and software program application (MUSIC-CARE)

MUSIC-CARE Group

control group OTHER

music relaxation using a music playlist supply (control group)

CONTROL group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled forearm orthopedic surgery
• locoregional anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Hospital of Paris: lead

Study Sites (1)

American Hospital of Paris

Neuilly-sur-Seine, 92200, France

Location

Related Publications (5)

• Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.

  PMID: 26277246 BACKGROUND

• Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.

  PMID: 22001666 BACKGROUND

• Graff V, Cai L, Badiola I, Elkassabany NM. Music versus midazolam during preoperative nerve block placements: a prospective randomized controlled study. Reg Anesth Pain Med. 2019 Jul 18:rapm-2018-100251. doi: 10.1136/rapm-2018-100251. Online ahead of print.

  PMID: 31320504 BACKGROUND

• Fu VX, Oomens P, Sneiders D, van den Berg SAA, Feelders RA, Wijnhoven BPL, Jeekel J. The Effect of Perioperative Music on the Stress Response to Surgery: A Meta-analysis. J Surg Res. 2019 Dec;244:444-455. doi: 10.1016/j.jss.2019.06.052. Epub 2019 Jul 18.

  PMID: 31326711 BACKGROUND

• Zengin S, Kabul S, Al B, Sarcan E, Dogan M, Yildirim C. Effects of music therapy on pain and anxiety in patients undergoing port catheter placement procedure. Complement Ther Med. 2013 Dec;21(6):689-96. doi: 10.1016/j.ctim.2013.08.017. Epub 2013 Sep 1.

  PMID: 24280479 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Anxiety Disorders; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Gilles BOCCARA, MD, PhD

  American Hospital of Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles BOCCARA, MD, PhD

CONTACT

+33 1 46 41 26 91; gilles.boccara@ahparis.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: During all the procedure, the anesthetist performing the locoregional anesthesia and the intravenous hypnotic administration, is blinded about the patient group and music program.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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").

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: August 23, 2021
• Study Start: March 10, 2023
• Primary Completion: March 15, 2023
• Study Completion: April 30, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)