Clinical trial NCT05002257: Impact of Listening to Music on Anxiety Postoperative in a Postanesthesic Care Unit (PACU) After Spinal Anesthesia
Official title: Impact of Listening to Music on Anxiety Postoperative in a Postanesthesic Care Unit (PACU) After Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Keywords: PACU
pain
care
music
anxiety
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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;

Primary outcomes:
measure: anxiety postoperative in a postanesthesic care unit (PACU) after spinal anesthesia
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: