Information and Music Therapy As a Means of Reducing Preoperative Anxiety in Outpatient Surgery. (Harmonie)

Hopital Foch

Status

Completed

Conditions

Ambulatory Surgery

Treatments

Procedure: music therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06461052

2023-A02493-42 (Registry Identifier)

2021_0188

Details and patient eligibility

About

This is a monocentric, prospective, before-and-after, open-label controlled study, two groups of 99 patients each: "control" group - usual care - versus "intervention" group "Intervention" group - patient information via an explanatory video followed by a 15-minute music therapy session of the patient's choice in the operating waiting room.

Full description

Although general anaesthesia is used for almost 10 million procedures a year, and the safety of this procedure has improved considerably over the last 25 years, notably with the "safety decree" of December 1994, general anaesthesia remains deeply associated with high levels of preoperative anxiety. Anxiety levels are correlated with two perioperative factors:

the need for more anesthetic agents to achieve the same level of depth of anesthesia in anxious patients compared to non-anxious/low-anxiety patients
Development of chronic postoperative pain.

The preoperative consultation and visit by an anaesthetist is an important meeting point to reduce these high levels of anxiety. On the other hand, systematic benzodiazepine-based premedication has been abandoned for some years now, and taking action to reduce the level of anxiety is one of today's challenges, using a variety of means: organizational, video, music, virtual reality, hypnosis...

Unfortunately, the level of publication on the subject remains low.

Currently, a local analysis of this pathway shows several waiting times for which patients are not necessarily informed, and which can generate anxiety during treatment. In addition, our preliminary survey on the subject showed a specific need for information on pain management and anaesthesia recovery. and anesthesia recovery.

The goal of this study was to design a two-group comparative study aiming of significantly reducing perioperative anxiety in outpatients by implementing simple solutions. More specifically, our project focuses on the impact of music therapy and dedicated information via an explanatory video of the patient's journey through the operating room on the level of perioperative anxiety.

Enrollment

198 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Any patient over the age of 18 undergoing scheduled outpatient surgery in the central
under general anesthesia. The surgeries surgeries concerned are versatile: Digestive (inguinal hernias, proctology, cholecystectomy, etc.), thoracic endoscopy (biopsy examination under GA), gynecological (hysteroscopy, diagnostic laparoscopy diagnostic laparoscopy, cerclage...), ENT (endoscopies, septoplasty, meatotomy...), Urology (JJ catheter insertionTOT/TVT, botulinum toxin injection...), vascular (stripping)
Patient with oral non-opposition prior to any study procedure
Not to have objected to inclusion in the research
Patient affiliated to a health insurance scheme

Exclusion criteria

Patients undergoing emergency surgery, considered full stomach
Patient not respecting the central block route (interventional radiology in this case)
First patients in the program because they present the risk of less than than 15 minutes
Patients who do not understand French
Patient deprived of liberty or under guardianship
Pregnant or breast-feeding women