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

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ClinicalTrials.gov Identifier: NCT02883959
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
LEGRIEL stephane, Versailles Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pain Other: music therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : February 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: music therapy
Music therapy
 Other: 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.
No Intervention: control arm
No music


Outcome Measures
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Primary Outcome Measures :
  1. proportion of pain exposure during nursing procedures [ Time Frame: 150 minutes ]
    total length of pain exposure to a BPS score over or equal to 5 divided by total length of nursing procedure


Secondary Outcome Measures :
  1. proportion of maximal pain exposure during nursing procedures [ Time Frame: 150 minutes ]
    Total length of exposure to the maximal BPS score (over or equal to 5) among total length of nursing procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883959


Locations
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France
CH Versailles
Le Chesnay, France
Sponsors and Collaborators
Versailles Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: LEGRIEL stephane, Study principal investigator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT02883959    
Other Study ID Numbers: 12/18_Painkiller
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by LEGRIEL stephane, Versailles Hospital:
critically ill
mechanical ventilation
pain
nursing
music