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

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.

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Key information

Conditions

Pain Critical Illness Disease Attributes Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Versailles

Le Chesnay, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Therapy

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.

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Acronym: Painkiller

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2016
First posted: Aug 30, 2016
Registry last updated: Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed