NCT04038593

Brief Summary

In France, home hospitalization services (HAD) are developing as an alternative to conventional hospitalization. In order to intervene at patients' home, a reason for referral must be defined. The most common one on the national territory is "complex dressing". Cares associated with these dressings can lead to symptoms such as pain and/or anxiety, and thus decrease the patient's quality of life. These two symptoms may be related, with the presence of one increasing the intensity of the other. Thus, drug treatments are often implemented as part of care, but may not be sufficient to relieve patients. Music has many interests in patients' pain and anxiety. MUSIC CARE© application allows the implementation of standardized musical interventions. It has been shown to be effective in reducing acute and chronic pain and anxiety in many clinical settings. The aim of this study is to evaluate the feasibility of implementing MUSIC CARE© in the care of complex dressings at home and to confirm its effectiveness on the symptoms experienced by patients. In addition, attention will be paid to the impact of this standardized musical intervention on care time, medication use during care and patients' and caregivers' satisfaction.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

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 13, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

July 13, 2019

Last Update Submit

March 16, 2022

Conditions

BandagePainAnxiety

Keywords

PainAnxietyComplex dressingHome hospitalizationMusic

Outcome Measures

Primary Outcomes (1)

  • Pain felt during the care: numerical scale

    Measurement by a numerical scale (0 the minimum to 10 the maximum)

    Immediately after the intervention

Secondary Outcomes (4)

  • Anxiety measurement

    Immediately before/after the intervention

  • Time needed for the care

    Immediately before/after the intervention

  • Satisfaction of patient and caregivers: numerical scale

    Immediately after the intervention

  • Treatment request by the patient during the care

    Immediately after the intervention

Study Arms (3)

Non interventional arm

NO INTERVENTION

Standard conditions of complex dressing cares, without experimental intervention. It will be a control intervention

Comparative arm with relaxation music from Youtube©

ACTIVE COMPARATOR

Standard conditions of complex dressing cares + use of non standardized music relaxation during complex dressing cares

Other: Youtube© relaxation music

Interventional arm with MUSIC CARE©

EXPERIMENTAL

Standard conditions of complex dressing cares + administration of a specific music therapy program (U method) delivered through headphones from a tablet, under the direction of trained nurses.

Device: MUSIC CARE© intervention

Interventions

Youtube© relaxation musicOTHER

Use of non standardized relaxation music with Youtube© during cares

Also known as: Youtube© condition
Comparative arm with relaxation music from Youtube©
MUSIC CARE© interventionDEVICE

Use of MUSIC CARE© during cares

Also known as: MUSIC CARE© condition
Interventional arm with MUSIC CARE©

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • reason for referral "complex dressing"
  • age \> 18 year old
  • inform consent
  • pain numerical scale ≥3 during care
  • able to speak and write French

You may not qualify if:

  • patients with a deficiency in auditive function
  • patients diagnosed with psychiatric pathologies
  • so-called vulnerable patients, ie under guardianship or curatorship, or deprived of their liberty by a judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Oeuvre de la Croix Saint-Simon

Paris, Île-de-France Region, 75019, France

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Jérémy Martin

    Fondation Oeuvre de la Croix Saint-Simon

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2019

First Posted

July 31, 2019

Study Start

January 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)