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

NCT05002257 | Completed

• 1 other identifier: PP21063
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia

Keywords

PACU; pain; care; music; anxiety

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Other: music therapy

Control arm

ACTIVE COMPARATOR

Other: No music therapy

Interventions

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.

Experimental Arm

No music therapy OTHER

Usual care

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 12, 2021
• Study Start: May 25, 2021
• Primary Completion: March 8, 2023
• Study Completion: July 8, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

FR (1)