This trial is active, not recruiting.

Condition pain
Treatment music therapy
Sponsor Central Hospital, Versailles
Collaborator Gwenaëlle JACQ, researcher nurse
Start date February 2013
End date October 2015
Trial size 60 participants
Trial identifier NCT02883959, 12/18_Painkiller


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Music therapy
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)
No music

Primary Outcomes

proportion of pain exposure during nursing procedures
time frame: 150 minutes

Secondary Outcomes

proportion of maximal pain exposure during nursing procedures
time frame: 150 minutes

Eligibility Criteria

Male or female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Central Hospital, Versailles.