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OpenTrials
Completed

NCT Number: NCT05002257

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damien JOLLY

Reims, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Music Therapy

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.

No music therapy

Other

Usual care

Primary outcomes

  1. anxiety postoperative in a postanesthesic care unit (PACU) after spinal anesthesia

    Time frame: Day 0

    Anxiety is assess by using Spielberg's STAI-Ya from 20 (no anxiety) to 80 (anxiety)

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: MusicAnx-SSPI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2021
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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