Efficiency of Favourite Versus Predetermined Musical Sequence on Gynecology Pre-operative Anxiety (MUANX)
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
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Reunion Island
-
Saint-Pierre, Reunion Island, Reunión, 97410
- CHU Reunion Island
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: MUSIC CARE
Listening for 20 min of one of the music style U sequences proposed by the medical device MUSIC CARE
|
Musicotherapy session using one of the U musical sequences of MUSIC CARE among the preselected music styles
Otros nombres:
|
|
Experimental: PERSONAL PLAY-LIST
Listening for 20 min of patient's play-list
|
Musicotherapy session using the patient's play-list composed by the patient with her favourite songs
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Situation anxiety measurement
Periodo de tiempo: Change from baseline anxiety at 20 minutes musical listening
|
Pre-operative anxiety is assessed by the STAY-situation questionnaire
|
Change from baseline anxiety at 20 minutes musical listening
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Blood pressure
Periodo de tiempo: Change from baseline blood pressure at 20 minutes musical listening
|
Measurement of blood pressure
|
Change from baseline blood pressure at 20 minutes musical listening
|
|
Post-operative pain
Periodo de tiempo: Up to one hour after surgery recovery
|
Pain is assessed after surgery recovery using Visual Analogic Scale
|
Up to one hour after surgery recovery
|
|
Care stay duration
Periodo de tiempo: At study completion, an average of 3 days
|
Hospital stay is assessed by the number of days
|
At study completion, an average of 3 days
|
|
Post-operative complications
Periodo de tiempo: Through study completion, an average of 3 days
|
All post-operative complications are recorded
|
Through study completion, an average of 3 days
|
|
Heart rate
Periodo de tiempo: Change from baseline heart at 20 minutes musical listening
|
Measurement of heart rate
|
Change from baseline heart at 20 minutes musical listening
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Malik Boukerrou, MD, Centre Hpospitalier Universitaire de La REUNION
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2016/CHU/04
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre MUSIC CARE
-
Fondation Oeuvre de la Croix Saint-SimonRetirado
-
Assistance Publique - Hôpitaux de ParisAún no reclutandoDolor | Dolor Postoperatorio | Ansiedad | Cirugía Torácica | Dolor, Pecho | Ansiedad Postoperatoria
-
Hospices Civils de LyonReclutamientoTrastorno de conducta | Terapia musicalFrancia
-
Assistance Publique - Hôpitaux de ParisDesconocidoCrisis vaso-oclusivaFrancia
-
Centre Hospitalier Universitaire de NīmesReclutamiento
-
Versailles Saint-Quentin-en-Yvelines UniversityDesconocidoDesorden del sueño | Insomnio crónicoFrancia
-
Niran ÇobanReclutamientoHernia de disco lumbar | Cirugía | Papel de la enfermeraTurquía (Türkiye)
-
Hediye KarakoçTerminadoEstrés | Ansiedad maternaTurquía (Türkiye)
-
NSCB Medical CollegeTerminadoNormal Sano Término Apropiado para la fecha Recién nacidoIndia
-
University of MiamiSociety of Critical Care MedicineTerminadoEnfermedad crítica | Síndrome de Unidad de Cuidados IntensivosEstados Unidos