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

NCT ID: NCT03226834

Last Updated: 2020-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-09-22

Brief Summary

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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

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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.

Conditions

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Surgery Anxiety State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

control randomized, single blind, monocentric
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators
blindness concerns medical staff: nurses in charge of the blood parameters measurements as well as anxiety evaluation are not informed of the allocation of the patients

Study Groups

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MUSIC CARE

Listening for 20 min of one of the music style U sequences proposed by the medical device MUSIC CARE

Group Type ACTIVE_COMPARATOR

MUSIC CARE

Intervention Type DEVICE

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

PERSONAL PLAY-LIST

Listening for 20 min of patient's play-list

Group Type EXPERIMENTAL

PERSONAL PLAY-LIST

Intervention Type OTHER

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

Interventions

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MUSIC CARE

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

Intervention Type DEVICE

PERSONAL PLAY-LIST

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

Intervention Type OTHER

Other Intervention Names

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Music Care U sequence Patient's paly-list

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malik Boukerrou, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hpospitalier Universitaire de La REUNION

Locations

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Chu Reunion Island

Saint-Pierre, Reunion Island, Reunion

Site Status

Countries

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Reunion

References

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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.

Reference Type DERIVED
PMID: 34389022 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30616674 (View on PubMed)

Other Identifiers

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2016/CHU/04

Identifier Type: -

Identifier Source: org_study_id

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