Impact of Listening to Music on Anxiety Postoperative in a Postanesthesic Care Unit (PACU) After Spinal Anesthesia (MusicAnx-SSPI)

CHU de Reims

Status: Completed

Conditions: Spinal Anesthesia

Treatments: Other: No music therapy; Other: music therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05002257

PP21063

Details and patient eligibility

About

Our hypothesis is that listening to music has a beneficial effect on the French population receiving spinal anesthesia for a scheduled procedure. We think we can reduce anxiety when switching to SSPI, using creative music therapy software (Music Care) French validated by clinical research.

Full description

We want to demonstrate that listening to music:

• decreases the anxiety of patients in PHC;
• improves their overall satisfaction unlike patients subjected to ambient noise from the SSPI. Demonstrate that there is a link between trait anxiety assessed preoperatively and state anxiety assessed immediate postoperative period to anticipate and improve patient care as soon as they arrive in SSPI. Extend music listening to all patients staying in a postoperative SSPI or for procedures performed in SSPI (bladder probing, central venous approach, post locoregional analgesia operative...) The Music Care software that we have chosen to use has been specifically developed to use the music as a therapeutic aid. Numerous abstracts and clinical studies have been published on the subject the use of this software in reducing anxiety, pain, behavioral and changes in hemodynamic parameters. It is based on the use of the so-called "U" method, which is a relaxation method based on hypno-analgesia, thus offering a complete relaxation session to patient.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

inclusion criteria :

• adult patients;
• undergoing scheduled orthopedic surgery, under spinal anesthesia;
• non-cancerous, functional;
• in traditional or outpatient hospitalization;
• requiring a passage in PACU;
• agreeing to participate in the study (consent form).

exclusion criteria :

• Children;
• under tutorship or curatorship;
• having known hearing problems (hearing loss or not, deafness) reported during the anesthesia consultation or detected during the collection of preoperative data; having cognitive disorders (dementia, disorientation) reported during the consultation of anesthesia, not allowing questions to be answered
• Patients equipped with their personal music.

The following will be excluded when they arrive in SSPI:

• Patients who received a benzodiazepine during the intraoperative period;
• Patients whose spinal anesthesia has been converted to general anesthesia;

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

Experimental Arm

Experimental group

Treatment:

Other: music therapy

Control arm

Active Comparator group

Treatment:

Other: No music therapy