Anxiety State, Surgery
Conditions
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.
Interventions
DEVICEMUSIC CARE
Musicotherapy session using one of the U musical sequences of MUSIC CARE among the preselected music styles
OTHERPERSONAL PLAY-LIST
Musicotherapy session using the patient's play-list composed by the patient with her favourite songs
Sponsors
Centre Hospitalier Universitaire de la Réunion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Masking description
blindness concerns medical staff: nurses in charge of the blood parameters measurements as well as anxiety evaluation are not informed of the allocation of the patients
Intervention model description
control randomized, single blind, monocentric
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Situation anxiety measurement | Change from baseline anxiety at 20 minutes musical listening | Pre-operative anxiety is assessed by the STAY-situation questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Care stay duration | At study completion, an average of 3 days | Hospital stay is assessed by the number of days |
| Post-operative complications | Through study completion, an average of 3 days | All post-operative complications are recorded |
| Heart rate | Change from baseline heart at 20 minutes musical listening | Measurement of heart rate |
Countries
Reunion
Outcome results
None listed