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

NCT ID: NCT05002257

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2023-07-08

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.

Conditions

Spinal Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental Arm

Group Type: EXPERIMENTAL

music therapy

Intervention Type: OTHER

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.

Control arm

Group Type: ACTIVE_COMPARATOR

No music therapy

Intervention Type: OTHER

Usual care

Interventions

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.

Intervention Type: OTHER

No music therapy

Usual care

Intervention Type: OTHER

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Damien JOLLY

Reims, , France

Countries

France

Other Identifiers

PP21063

Identifier Type: -

Identifier Source: org_study_id