NCT03226834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

July 31, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2018

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

July 18, 2017

Last Update Submit

February 17, 2020

Conditions

SurgeryAnxiety State

Outcome Measures

Primary Outcomes (1)

  • Situation anxiety measurement

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

    Change from baseline anxiety at 20 minutes musical listening

Secondary Outcomes (5)

  • Blood pressure

    Change from baseline blood pressure at 20 minutes musical listening

  • Post-operative pain

    Up to one hour after surgery recovery

  • Care stay duration

    At study completion, an average of 3 days

  • Post-operative complications

    Through study completion, an average of 3 days

  • Heart rate

    Change from baseline heart at 20 minutes musical listening

Study Arms (2)

MUSIC CARE

ACTIVE COMPARATOR

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

Device: MUSIC CARE

PERSONAL PLAY-LIST

EXPERIMENTAL

Listening for 20 min of patient's play-list

Other: PERSONAL PLAY-LIST

Interventions

MUSIC CAREDEVICE

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

Also known as: Music Care U sequence
MUSIC CARE
PERSONAL PLAY-LISTOTHER

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

Also known as: Patient's paly-list
PERSONAL PLAY-LIST

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • with planed gynecologic surgery
  • without anxiolytic medication
  • able to prepare their own play-list
  • signed inform consent

You may not qualify if:

  • hearing disorder
  • dementia or psychiatric disorder
  • neurologic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reunion Island

Saint-Pierre, Reunion Island, 97410, Reunion

Location

Related Publications (2)

  • 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.

    PMID: 34389022DERIVED

  • 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.

    PMID: 30616674DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Malik Boukerrou, MD

    Centre Hpospitalier Universitaire de La REUNION

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
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
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: control randomized, single blind, monocentric
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 24, 2017

Study Start

July 31, 2017

Primary Completion

September 22, 2018

Study Completion

September 22, 2018

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

RE(1)