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

Pain Clinical Trial

— Painkiller  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883959
• Other study ID #: 12/18_Painkiller
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: October 2016

Study information

• Verified date: July 2018
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
France	CH Versailles	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	proportion of maximal pain exposure during nursing procedures	Total length of exposure to the maximal BPS score (over or equal to 5) among total length of nursing procedure	150 minutes