Clinical Trials Directory

Trials / Completed

CompletedNCT05398211

Music Therapy as a Treatment for Delirium in Acutely Hospitalized Older Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
26 (actual)
Sponsor
Oslo University Hospital · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to assess feasibility and potential effectiveness of two different music interventions for managing delirium symptoms in acute geriatric patients.

Detailed description

Delirium is a neuropsychiatric syndrome characterized by an acute alteration in attention, awareness, arousal and cognition, precipitated by an acute illness, intoxication, trauma or surgery. It is highly prevalent in older, frail and acutely hospitalized patients, and associated with poor outcomes, with few effective treatment alternatives. Non-pharmacological interventions and music show promising effects. This study protocol aims to determine whether music interventions (MIs) delivered by a credentialed music therapist, are feasible and effective for regulating delirium symptoms in acute geriatric patients and whether the standardized delirium tools are sensitive to detect observable responses. Primary, feasibility outcomes are evaluating recruitment rate, treatment fidelity and adherence, as well as feasibility and accuracy in data collection procedures. Main effect-outcome is delirium severity, but delirium duration, cognitive status, length of hospital stay, and medication use will also be recorded. The randomised repeated measures controlled trial design will record the participant responses before and after exposure to MIs (+/- 2 hours). Participants with delirium from an acute geriatric ward will be randomized to either live or recorded MI. Each intervention will be delivered to n=30 participants (n=60 in total), for 30 minutes, over three consecutive days. Ethical approval has been obtained from Regional Ethics Committee South East Norway.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPreferred Recorded Music (PRM)Preferred Recorded Music (PRM) involves a credentialed music therapist in planning and administering, which qualifies it as music therapy, which is defined as a professional use of music and its elements to improve physical, social, communicative, emotional, intellectual, and spiritual health, optimize quality of life and wellbeing(Aigen, 2013; Bruscia, 2014). PRM intervention will be delivered for 30 minutes, once per day at the same time of the day, for three consecutive days. The intervention will consist of the previously assessed preferred songs/musical pieces. During the PRM intervention the MT will start/stop the music and otherwise not engage with the participants during the listening session.
BEHAVIORALPreferred Live Music (PLM)Preferred Live Music (PLM) involves a credentialed music therapist in planning and administering which qualifies it as music therapy, which is defined as professional use of music and its elements to improve physical, social, communicative, emotional, intellectual and spiritual health, optimize quality of life and wellbeing (Aigen, 2013; Bruscia, 2014).PRM intervention will be delivered for 30 minutes, once per day at the same time of the day, for three consecutive days. The intervention will consist of the previously assessed preferred songs/musical pieces. The MT will be more actively engaged in a musical interaction with the participants in the PLM interventions.

Timeline

Start date
2022-06-15
Primary completion
2023-05-31
Completion
2023-05-31
First posted
2022-05-31
Last updated
2024-04-30

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT05398211. Inclusion in this directory is not an endorsement.