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

Not Applicable

Recruiting

• Conditions: Spinal Anesthesia
• Interventions: Other: No music therapy; Other: music therapy

• Registration Number: NCT05002257
• Lead Sponsor: CHU de Reims

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.

Study Timeline

• Study Start: 2021-05-25
• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-23
• Last Update Posted: 2022-09-26
• Primary Completion: 2023-09-25
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	No music therapy	-
Experimental Arm	music therapy	-

Primary Outcome Measures

Name	Time	Method
anxiety postoperative in a postanesthesic care unit (PACU) after spinal anesthesia	Day 0	Anxiety is assess by using Spielberg's STAI-Ya from 20 (no anxiety) to 80 (anxiety)

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France