Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 Ã 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.
Patients are randomly allocated in two groups:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MUSIC CARE | Active Comparator | Listening for 20 min of one of the music style U sequences proposed by the medical device MUSIC CARE |
|
| PERSONAL PLAY-LIST | Experimental | Listening for 20 min of patient's play-list |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MUSIC CARE | Device | Musicotherapy session using one of the U musical sequences of MUSIC CARE among the preselected music styles |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Malik Boukerrou, MD | Centre Hpospitalier Universitaire de La REUNION | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Reunion Island | Saint-Pierre | Reunion Island | 97410 | Reunion |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34389022 | Derived | Reynaud D, Bouscaren N, Lenclume V, Boukerrou M. Comparing the effects of self-selected MUsic versus predetermined music on patient ANXiety prior to gynaecological surgery: the MUANX randomized controlled trial. Trials. 2021 Aug 13;22(1):535. doi: 10.1186/s13063-021-05511-2. | |
| 30616674 | Derived | Petot T, Bouscaren N, Maillard O, Huiart L, Boukerrou M, Reynaud D. Comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery: a study protocol for a randomised controlled trial. Trials. 2019 Jan 7;20(1):20. doi: 10.1186/s13063-018-3093-6. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
control randomized, single blind, monocentric
Not provided
Not provided
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
| PERSONAL PLAY-LIST | Other | Musicotherapy session using the patient's play-list composed by the patient with her favourite songs |
|
|
| 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 |