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

NCT03226834 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2020-02-18

No results posted yet for this study

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.

Conditions

  • Surgery
  • Anxiety State

Interventions

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de la Réunion

    lead OTHER

Principal Investigators

  • Malik Boukerrou, MD · Centre Hpospitalier Universitaire de La REUNION

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2018-09-22
Completion
2018-09-22

Countries

  • Reunion

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03226834 on ClinicalTrials.gov