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

Primary Purpose

Surgery, Anxiety State

Status
Completed
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
MUSIC CARE
PERSONAL PLAY-LIST
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgery

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Reunion Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MUSIC CARE

PERSONAL PLAY-LIST

Arm Description

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

Listening for 20 min of patient's play-list

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Blood pressure
Measurement of blood pressure
Post-operative pain
Pain is assessed after surgery recovery using Visual Analogic Scale
Care stay duration
Hospital stay is assessed by the number of days
Post-operative complications
All post-operative complications are recorded
Heart rate
Measurement of heart rate

Full Information

First Posted
July 18, 2017
Last Updated
February 17, 2020
Sponsor
Centre Hospitalier Universitaire de la Réunion
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1. Study Identification

Unique Protocol Identification Number
NCT03226834
Brief Title
Efficiency of Favourite Versus Predetermined Musical Sequence on Gynecology Pre-operative Anxiety
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
September 22, 2018 (Actual)
Study Completion Date
September 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Anxiety State

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
control randomized, single blind, monocentric
Masking
Care ProviderInvestigator
Masking Description
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
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MUSIC CARE
Arm Type
Active Comparator
Arm Description
Listening for 20 min of one of the music style U sequences proposed by the medical device MUSIC CARE
Arm Title
PERSONAL PLAY-LIST
Arm Type
Experimental
Arm Description
Listening for 20 min of patient's play-list
Intervention Type
Device
Intervention Name(s)
MUSIC CARE
Other Intervention Name(s)
Music Care U sequence
Intervention Description
Musicotherapy session using one of the U musical sequences of MUSIC CARE among the preselected music styles
Intervention Type
Other
Intervention Name(s)
PERSONAL PLAY-LIST
Other Intervention Name(s)
Patient's paly-list
Intervention Description
Musicotherapy session using the patient's play-list composed by the patient with her favourite songs
Primary Outcome Measure Information:
Title
Situation anxiety measurement
Description
Pre-operative anxiety is assessed by the STAY-situation questionnaire
Time Frame
Change from baseline anxiety at 20 minutes musical listening
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Measurement of blood pressure
Time Frame
Change from baseline blood pressure at 20 minutes musical listening
Title
Post-operative pain
Description
Pain is assessed after surgery recovery using Visual Analogic Scale
Time Frame
Up to one hour after surgery recovery
Title
Care stay duration
Description
Hospital stay is assessed by the number of days
Time Frame
At study completion, an average of 3 days
Title
Post-operative complications
Description
All post-operative complications are recorded
Time Frame
Through study completion, an average of 3 days
Title
Heart rate
Description
Measurement of heart rate
Time Frame
Change from baseline heart at 20 minutes musical listening

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malik Boukerrou, MD
Organizational Affiliation
Centre Hpospitalier Universitaire de La REUNION
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Reunion Island
City
Saint-Pierre
State/Province
Reunion Island
ZIP/Postal Code
97410
Country
Réunion

12. IPD Sharing Statement

Citations:
PubMed Identifier
34389022
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.
Results Reference
derived
PubMed Identifier
30616674
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.
Results Reference
derived

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

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