Clinical trial NCT03226834: Efficiency of Favourite Versus Predetermined Musical Sequence on Gynecology Pre-operative Anxiety
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Anxiety State
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control randomized, single blind, monocentric
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Situation anxiety measurement
timeFrame: Change from baseline anxiety at 20 minutes musical listening
Secondary outcomes:
measure: Blood pressure
timeFrame: Change from baseline blood pressure at 20 minutes musical listening
measure: Post-operative pain
timeFrame: Up to one hour after surgery recovery
measure: Care stay duration
timeFrame: At study completion, an average of 3 days
measure: Post-operative complications
timeFrame: Through study completion, an average of 3 days
measure: Heart rate
timeFrame: Change from baseline heart at 20 minutes musical listening
Other outcomes:
Locations:
city: Saint-Pierre
country: Réunion
facility: Chu Reunion Island
state: Reunion Island
Study officials:
affiliation: Centre Hpospitalier Universitaire de La REUNION
name: Malik Boukerrou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.