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

Not Applicable

Completed

• Conditions: Surgery; Anxiety State
• Interventions: Device: MUSIC CARE; Other: PERSONAL PLAY-LIST

• Registration Number: NCT03226834
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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.

Study Timeline

• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-24
• Study Start: 2017-07-31
• Primary Completion: 2018-09-22
• Study Completion: 2018-09-22
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-17
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MUSIC CARE	MUSIC CARE	Listening for 20 min of one of the music style U sequences proposed by the medical device MUSIC CARE
PERSONAL PLAY-LIST	PERSONAL PLAY-LIST	Listening for 20 min of patient's play-list

Primary Outcome Measures

Name	Time	Method
Situation anxiety measurement	Change from baseline anxiety at 20 minutes musical listening	Pre-operative anxiety is assessed by the STAY-situation questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chu Reunion Island; 🇷🇪 Saint-Pierre, Reunion Island, Réunion