Efficiency of Favourite Versus Predetermined Musical Sequence on Gynecology Pre-operative Anxiety

Study Overview
=================
Brief Summary
-----------------
Anxiety is a psychologic and physiological state that could be characterized by somatic, emotional, cognitive and behavioral components. Surgery, as well as waiting for surgery is an anxiogenic situation encountered by 60 à 80 % of the patients. High levels of anxiety lead to negative physiological signs that slow down healing, lowers imune response and increases post-surgery infection. Anxiety also increases pain and post-surgery morbi-mortality. Drug-induced sedation is frequently recommended to lower anxiety. The anxiolytic effect of alternative treatment such as musicotherapy has been demonstrated in several randomized control trials. Nevertheless, most of these studies have investigated the effect of musicotherapy in groups with our without musical listening. In the present study, investigators assume that a personal musical sequence composed by favourite songs of the patients could have beneficial effect on presurgical anxiety than selective sequence of the medical device MUSIC CARE. In this study, the anxiolytic effect of predefined U musical sequences that alternate slow and faster music tracks (medical device MUSIC CARE) are compared to patient's play-list, in women with planned gynecological surgery.

Detailed Description
-----------------
Patients are randomly allocated in two groups: control group: patients are asked to choose one of the U sequence among the preselected music style proposed by the medical device MUSIC CARE test group: patients are asked to prepare their own play-list containing their favourite songs Anxiety is assessed before and after a 20 min-musicotherapy session by using the State-Trait Anxiety Inventory (STAI) for anxiogenic situation. Other parameters are measured such as blood pressure, cardiac frequency, level of pain after surgery, care stay duration, potent post-surgery complications.

Official Title
-----------------
Comparison of Musicotherapy Sessions Using Patient Play-list Versus U Sequence Music Care Medical Device on Pre-operative Anxiety in Women Undergoing Gynecological Surgery: a Randomized-control Study

Conditions
-----------------
Surgery, Anxiety State

Intervention / Treatment
-----------------
* Device: MUSIC CARE
* Other: PERSONAL PLAY-LIST


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with planed gynecologic surgery without anxiolytic medication able to prepare their own play-list signed inform consent Exclusion Criteria: hearing disorder dementia or psychiatric disorder neurologic disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: control randomized, single blind, monocentric
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MUSIC CARE<br>Listening for 20 min of one of the music style U sequences proposed by the medical device MUSIC CARE | Device: MUSIC CARE<br>* Musicotherapy session using one of the U musical sequences of MUSIC CARE among the preselected music styles<br>* Other names: Music Care U sequence;|
| Experimental: PERSONAL PLAY-LIST<br>Listening for 20 min of patient's play-list | Other: PERSONAL PLAY-LIST<br>* Musicotherapy session using the patient's play-list composed by the patient with her favourite songs<br>* Other names: Patient's paly-list;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Situation anxiety measurement | Pre-operative anxiety is assessed by the STAY-situation questionnaire | Change from baseline anxiety at 20 minutes musical listening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Measurement of blood pressure | Change from baseline blood pressure at 20 minutes musical listening | 
| Post-operative pain | Pain is assessed after surgery recovery using Visual Analogic Scale | Up to one hour after surgery recovery | 
| Care stay duration | Hospital stay is assessed by the number of days | At study completion, an average of 3 days | 
| Post-operative complications | All post-operative complications are recorded | Through study completion, an average of 3 days | 
| Heart rate | Measurement of heart rate | Change from baseline heart at 20 minutes musical listening |