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

Spinal Anesthesia Clinical Trial

— MusicAnx-SSPI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05002257
• Other study ID #: PP21063
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: January 2024

Study information

• Verified date: September 2022
• Source: CHU de Reims
• Contact: Virginie ROUET
• Phone: 03 26 78 86 81
• Email: vrouet[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 2024
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Anxiety Disorders
• Spinal Anesthesia

Intervention

Other:
• music therapy
Patients included in the intervention arm with music therapy will choose among 3 possible music: music from elsewhere, classical music, today's music. These 3 music thearpy will have an identical duration of 20 minutes.
• No music therapy
Usual care

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anxiety postoperative in a postanesthesic care unit (PACU) after spinal anesthesia	Anxiety is assess by using Spielberg's STAI-Ya from 20 (no anxiety) to 80 (anxiety)	Day 0