SurgeryMUANXNCT03226834
Efficiency of Favourite Versus Predetermined Musical Sequence on Gynecology Pre-operative Anxiety
A study testing MUSIC CARE and PERSONAL PLAY-LIST in people with Surgery and Anxiety State, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Surgery, Anxiety State
- What is being tested?
- MUSIC CARE and PERSONAL PLAY-LIST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteReunion
- Study dates
- 31 Jul 2017to 22 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- with planed gynecologic surgery
- without anxiolytic medication
- able to prepare their own play-list
- signed inform consent
Who cannot join
- hearing disorder
- dementia or psychiatric disorder
- neurologic disorder
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Surgery, Anxiety State
- Being tested
- MUSIC CARE, PERSONAL PLAY-LIST
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUSIC CAREDevice
Also called Music Care U sequence
Musicotherapy session using one of the U musical sequences of MUSIC CARE among the preselected music styles
PERSONAL PLAY-LISTOther
Also called Patient's paly-list
Musicotherapy session using the patient's play-list composed by the patient with her favourite songs
| Study group | Role | What they receive |
|---|---|---|
| MUSIC CARE | Active comparator | Listening for 20 min of one of the music style U sequences proposed by the medical device MUSIC CARE Receives: Device: MUSIC CARE |
| PERSONAL PLAY-LIST | Experimental | Listening for 20 min of patient's play-list Receives: Other: PERSONAL PLAY-LIST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Situation anxiety measurement
Pre-operative anxiety is assessed by the STAY-situation questionnaire
Measured: Change from baseline anxiety at 20 minutes musical listening
Secondary outcomes (5)
Blood pressure
Measurement of blood pressure
Measured: Change from baseline blood pressure at 20 minutes musical listening
Post-operative pain
Pain is assessed after surgery recovery using Visual Analogic Scale
Measured: Up to one hour after surgery recovery
Care stay duration
Hospital stay is assessed by the number of days
Measured: At study completion, an average of 3 days
Post-operative complications
All post-operative complications are recorded
Measured: Through study completion, an average of 3 days
Heart rate
Measurement of heart rate
Measured: Change from baseline heart at 20 minutes musical listening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start31 Jul 2017
- Primary completion22 Sep 2018
- Study completion22 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- control randomized, single blind, monocentric
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malik Boukerrou, MD, Principal investigator, Centre Hpospitalier Universitaire de La REUNION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226834
- Sponsor's protocol ID
- 2016/CHU/04
- Acronym
- MUANX
- Status last verified
- Feb 2020
- First submitted
- 18 Jul 2017
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34389022Petot 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.
PubMed 30616674
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03226834
- Acronym / sponsor ID
- MUANX / 2016/CHU/04
- Conditions
- Surgery, Anxiety State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 22 Sep 2018 (actual)
- Study completion
- 22 Sep 2018 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- control randomized, single blind, monocentric
| Arm | Type | Receives |
|---|---|---|
| MUSIC CARE | Active comparator | Device: MUSIC CAREListening for 20 min of one of the music style U sequences proposed by the medical device MUSIC CARE |
| PERSONAL PLAY-LIST | Experimental | Other: PERSONAL PLAY-LISTListening for 20 min of patient's play-list |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- with planed gynecologic surgery
- without anxiolytic medication
- able to prepare their own play-list
- signed inform consent
Key exclusion criteria (3 listed)
- hearing disorder
- dementia or psychiatric disorder
- neurologic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MUSIC CAREAlso: Music Care U sequenceMusicotherapy session using one of the U musical sequences of MUSIC CARE among the preselected music styles | Device | MUSIC CARE |
| PERSONAL PLAY-LISTAlso: Patient's paly-listMusicotherapy session using the patient's play-list composed by the patient with her favourite songs | Other | PERSONAL PLAY-LIST |
Primary outcome
Situation anxiety measurement
Time frame: Change from baseline anxiety at 20 minutes musical listening
Pre-operative anxiety is assessed by the STAY-situation questionnaire
5 secondary outcomes
Blood pressure
Time frame: Change from baseline blood pressure at 20 minutes musical listening
Post-operative pain
Time frame: Up to one hour after surgery recovery
Care stay duration
Time frame: At study completion, an average of 3 days
Post-operative complications
Time frame: Through study completion, an average of 3 days
Heart rate
Time frame: Change from baseline heart at 20 minutes musical listening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Derived from this study: PubMed 34389022Reynaud 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.
- Derived from this study: PubMed 30616674Petot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malik Boukerrou, MD principal investigator
Centre Hpospitalier Universitaire de La REUNION
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MUSIC CARE and PERSONAL PLAY-LIST in people with Surgery and Anxiety State, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Situation anxiety measurement (time frame: Change from baseline anxiety at 20 minutes musical listening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03226834, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.