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Completed

NCT Number: NCT03226834

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

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.

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Key information

Conditions

Surgery Anxiety Disorders Anxiety State Mental Disorders

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chu Reunion Island

Saint-Pierre, Reunion Island, 97410, Reunion

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MUSIC CARE

Device

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

Other names: Music Care U sequence

PERSONAL PLAY-LIST

Other

Musicotherapy session using the patient's play-list composed by the patient with her favourite songs

Other names: Patient's paly-list

Primary outcomes

  1. Situation anxiety measurement

    Time frame: Change from baseline anxiety at 20 minutes musical listening

    Pre-operative anxiety is assessed by the STAY-situation questionnaire

Secondary outcomes

  1. Blood pressure

    Time frame: Change from baseline blood pressure at 20 minutes musical listening

    Measurement of blood pressure

  2. Post-operative pain

    Time frame: Up to one hour after surgery recovery

    Pain is assessed after surgery recovery using Visual Analogic Scale

  3. Care stay duration

    Time frame: At study completion, an average of 3 days

    Hospital stay is assessed by the number of days

  4. Post-operative complications

    Time frame: Through study completion, an average of 3 days

    All post-operative complications are recorded

  5. Heart rate

    Time frame: Change from baseline heart at 20 minutes musical listening

    Measurement of heart rate

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study 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

Acronym: MUANX

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2017
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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