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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Anxiety State
• Intervention / Treatment: Device: MUSIC CARE; Other: PERSONAL PLAY-LIST

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.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Réunion
  • Reunion Island
    • Saint-Pierre, Reunion Island, Réunion, 97410
      • CHU Reunion Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MUSIC CARE; Listening for 20 min of one of the music style U sequences proposed by the medical device MUSIC CARE	Device: MUSIC CARE; Musicotherapy session using one of the U musical sequences of MUSIC CARE among the preselected music styles; Other Names: Music Care U sequence
Experimental: PERSONAL PLAY-LIST; Listening for 20 min of patient's play-list	Other: PERSONAL PLAY-LIST; Musicotherapy session using the patient's play-list composed by the patient with her favourite songs; Other Names: Patient's paly-list

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Situation anxiety measurement	Pre-operative anxiety is assessed by the STAY-situation questionnaire	Change from baseline anxiety at 20 minutes musical listening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Measurement of blood pressure	Change from baseline blood pressure at 20 minutes musical listening
Post-operative pain	Pain is assessed after surgery recovery using Visual Analogic Scale	Up to one hour after surgery recovery
Care stay duration	Hospital stay is assessed by the number of days	At study completion, an average of 3 days
Post-operative complications	All post-operative complications are recorded	Through study completion, an average of 3 days
Heart rate	Measurement of heart rate	Change from baseline heart at 20 minutes musical listening

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Malik Boukerrou, MD, Centre Hpospitalier Universitaire de La REUNION

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Actual): September 22, 2018
• Study Completion (Actual): September 22, 2018

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2016/CHU/04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No