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

Surgery Clinical Trial

— MUANX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226834
• Other study ID #: 2016/CHU/04
• Status: Completed
• Phase: N/A
• Start date: July 31, 2017
• Est. completion date: September 22, 2018

Study information

• Verified date: February 2020
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: September 22, 2018
• Est. primary completion date: September 22, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Surgery

Intervention

Device:
• MUSIC CARE
Musicotherapy session using one of the U musical sequences of MUSIC CARE among the preselected music styles

Other:
• PERSONAL PLAY-LIST
Musicotherapy session using the patient's play-list composed by the patient with her favourite songs

Locations

Country	Name	City	State
Réunion	Chu Reunion Island	Saint-Pierre	Reunion Island

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Situation anxiety measurement	Pre-operative anxiety is assessed by the STAY-situation questionnaire	Change from baseline anxiety at 20 minutes musical listening
Secondary	Blood pressure	Measurement of blood pressure	Change from baseline blood pressure at 20 minutes musical listening
Secondary	Post-operative pain	Pain is assessed after surgery recovery using Visual Analogic Scale	Up to one hour after surgery recovery
Secondary	Care stay duration	Hospital stay is assessed by the number of days	At study completion, an average of 3 days
Secondary	Post-operative complications	All post-operative complications are recorded	Through study completion, an average of 3 days
Secondary	Heart rate	Measurement of heart rate	Change from baseline heart at 20 minutes musical listening