Evaluation of the Analgesic Effect of Music Therapy in Critically Ill Patients During Potentially Painful Nursing Procedures: a Pilot Study

NCT ID: NCT02883959

Last Updated: 2018-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-10-31

Brief Summary

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Pain is a common problem encountered in about 60 % of critically ill patients who can communicate. Its occurrence can be related to several causes, mainly dominated by invasive procedures.

Pain management is typically based on a combination of prevention, evaluation, and therapeutic agents. However, it appears important to develop adjuvant approaches. Music therapy is one of them and that has been evaluated in various medical conditions.

The aim of our study is to evaluate the analgesic effect of music therapy in critically ill patients during potentially painful nursing procedures.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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music therapy

Music therapy

Group Type EXPERIMENTAL

music therapy

Intervention Type OTHER

Music therapy will be delivered through headphones during nursing procedures (toilet and/or surgical dressings): from initiation up to 30 minutes after the end of procedure.

control arm

No music

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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music therapy

Music therapy will be delivered through headphones during nursing procedures (toilet and/or surgical dressings): from initiation up to 30 minutes after the end of procedure.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All adult patients (age≄18 years) hospitalized in Intensive Care Unit
* Requiring mechanical ventilation
* Who cannot communicate
* With a Richmond Agitation Sedation Scale (RASS) score \[-3; +4\]

Exclusion Criteria

* Age \< 18 years
* Receiving neuromuscular blockade
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Versailles Hospital

OTHER

Sponsor Role lead

Responsible Party

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LEGRIEL stephane

Study principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CH Versailles

Le Chesnay, , France

Site Status

Countries

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France

References

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Jacq G, Melot K, Bezou M, Foucault L, Courau-Courtois J, Cavelot S, Lang A, Bedos JP, Le-Boeuf D, Boussard JM, Legriel S. Music for pain relief during bed bathing of mechanically ventilated patients: A pilot study. PLoS One. 2018 Nov 14;13(11):e0207174. doi: 10.1371/journal.pone.0207174. eCollection 2018.

Reference Type DERIVED
PMID: 30427906 (View on PubMed)

Other Identifiers

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12/18_Painkiller

Identifier Type: -

Identifier Source: org_study_id

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