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

Sponsor

CHU de Reims (Other)

Overall Status

Recruiting

CT.gov ID

NCT05002257

Collaborator

(none)

200

Enrollment

Location

Arms

15.2

Anticipated Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Anesthesia	Other: music therapy Other: No music therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 25, 2021

Anticipated Primary Completion Date :

May 25, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Arm	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.
Active Comparator: Control arm	Other: No music therapy Usual care

Arm

Intervention/Treatment

Experimental: Experimental Arm

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.

Active Comparator: Control arm

Other: No music therapy

Usual care

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.