Evaluation of the Analgesic Effect of Music Therapy in Critically Ill Patients During Potentially Painful Nursing Procedures: a Pilot Study
Painkiller
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Feb 2013
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 25, 2016
CompletedFirst Posted
Study publicly available on registry
August 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJuly 11, 2018
July 1, 2018
2.7 years
August 25, 2016
July 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proportion of pain exposure during nursing procedures
total length of pain exposure to a BPS score over or equal to 5 divided by total length of nursing procedure
150 minutes
Secondary Outcomes (1)
proportion of maximal pain exposure during nursing procedures
150 minutes
Study Arms (2)
music therapy
EXPERIMENTALMusic therapy
control arm
NO INTERVENTIONNo music
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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 \[-3; +4\]
You may not qualify if:
- Age \< 18 years
- Receiving neuromuscular blockade
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CH Versailles
Le Chesnay, France
Related Publications (1)
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.
PMID: 30427906DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study principal investigator
Study Record Dates
First Submitted
August 25, 2016
First Posted
August 30, 2016
Study Start
February 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2016
Last Updated
July 11, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share