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

Centre Hospitalier Universitaire de la Réunion

Status: Completed

Conditions: Surgery; Anxiety State

Treatments: Device: MUSIC CARE; Other: PERSONAL PLAY-LIST

Study type: Interventional

Funder types: Other

Identifiers

NCT03226834

2016/CHU/04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

MUSIC CARE

Active Comparator group

Description:

Listening for 20 min of one of the music style U sequences proposed by the medical device MUSIC CARE

Treatment:

Device: MUSIC CARE

PERSONAL PLAY-LIST

Experimental group

Description:

Listening for 20 min of patient's play-list

Treatment:

Other: PERSONAL PLAY-LIST