Translating the HAM-D into the MADRS and vice versa with equipercentile linking.
Stefan Leucht, Hein Fennema, Rolf R Engel...
https://pubmed.ncbi.nlm.nih.gov/29031182Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06817330
Effect of a Music Intervention on Postictal Agitation in Electroconvulsive Therapy Patients: the MUSE Trial
Led by Erasmus Medical Center · Updated on 2025-12-17
92
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
P
Parnassia Groep
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of music on postictal agitation (PIA) in patients undergoing electroconvulsive therapy (ECT) for severe depression. PIA is a common side effect after ECT that can predict other complications like memory loss. Since music has been shown to reduce anxiety and medication needs in surgery patients, this study aims to see if playing music around ECT treatment can lower PIA and cognitive problems afterwards. Participants are randomly assigned to one of two groups. One group listens to recorded music through headphones for 30 minutes before ECT and 12 minutes after the treatment while recovering. The control group wears headphones with no music for the same time periods to match noise reduction. Music selections are made by patients from pre-created playlists, and researchers note any refusal to wear headphones or listen. During the study, researchers monitor postictal agitation presence, severity, and duration within 30 minutes after ECT. They also assess anxiety before and after the music or control intervention, recovery time after ECT, medication use, cognitive function up to 90 days post-treatment, and depression severity during the ECT course. Participation involves regular ECT sessions with these assessments and observation to understand the impact of music on recovery and side effects.
CONDITIONS
Brief Title
The Effect of a Music Intervention on Postictal Agitation in Electroconvulsive Therapy Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients undergoing ECT treatment for depression, including depression as part of bipolar disorder
- Adults aged 18 years or older
- Use of etomidate as the hypnotic agent
- Sufficient understanding of the Dutch language as judged by physician or researcher
- Written informed consent by patient or legal representative
You will not qualify if you...
- Significant impaired hearing, unable to communicate verbally or listen to music
- Severe neurological condition interfering with ability to process music
- Patients receiving ECT for treatment of schizophrenic disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 4 months during the ECT course
Participants receive electroconvulsive therapy (ECT) sessions during which they listen to recorded music or wear headphones without music for 30 minutes before and 12 minutes after each ECT session to assess the effect on postictal agitation.
Weekly visits during ECT sessions
Follow-up
Duration - Up to 90 days after completing ECT course
Participants are monitored for cognitive impairment and severity of depression up to 90 days after completing the ECT course.
Visits within 7 days prior and at 2 and 90 days after ECT course completion
Trial Site Locations
Total: 2 locations
1
Erasmus Medical Center
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
2
Antes Parnassia Group
Rotterdam, Netherlands, 3079 DC
Actively Recruiting
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Research Team
E
Emy S van der Valk Bouman, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
An Investigation of Patient Preferences for Music Played Before Electroconvulsive Therapy.
Veena Graff, Peter Wingfield, David Adams...
https://pubmed.ncbi.nlm.nih.gov/27075143Severe Postictal Confusion After Electroconvulsive Therapy: A Retrospective Study.
Gijsbert Schuur, Joey P A J Verdijk, Freek Ten Doesschate...
https://pubmed.ncbi.nlm.nih.gov/36825989Adverse Effects of Electroconvulsive Therapy.
Chittaranjan Andrade, Shyam Sundar Arumugham, Jagadisha Thirthalli
https://pubmed.ncbi.nlm.nih.gov/27514303Prognostic Factors and Incidence for Postictal Agitation After Electroconvulsive Therapy: A Systematic Review and Meta-analysis.
Melissa Ertman, Emy S van der Valk Bouman, Pascal R D Clephas...
https://pubmed.ncbi.nlm.nih.gov/39105589Effect of peri-interventional music on postictal agitation in electroconvulsive therapy patients (MUSE): protocol for an open-label multicentre randomised controlled trial in the Netherlands.
Emilie S van der Valk Bouman, Melissa Ertman, Michel R Koopmans...
https://pubmed.ncbi.nlm.nih.gov/41371746