Clinical trial NCT06817330: The Effect of a Music Intervention on Postictal Agitation in Electroconvulsive Therapy Patients
Official title: the Effect of a MUsic Intervention on poStictal Agitation in Electroconvulsive Therapy Patients: the MUSE Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Music Intervention
Electroconvulsive Therapy Treated Patients
Agitation on Recovery From Sedation
Keywords: music
postictal agitation
electroconvulsive therapy
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Parnassia Groep
First posted: 2025-02-10
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center prospective randomized controlled trial with a parallel design.
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect of music on postictal agitation when played peri-interventionally for patients undergoing electroconvulsive therapy for severe depression.

Detailed description: Postictal agitation (PIA) is a fairly common adverse effect after electroconvulsive therapy (ECT) treatment that, when present, predicts other complications such as retrograde amnesia. Multiple studies have suggested that a music intervention in the context of surgery significantly reduces pre-operative anxiety, as well as the need for sedatives and analgesic medication. Pretreatment anxiety is common for ECT patients and is a known predictor of PIA. Currently, there is no preventative treatment for PIA. Given the beneficial effects of music demonstrated in similar hospital settings combined with its easy implementation and lack of side effects, the investigators hypothesize that music listening can lower the incidence and severity of PIA among patients undergoing ECT therapy, thereby also reducing post-treatment cognitive impairment. Therefore, the objective of the study is to assess the effect of music on postictal agitation when played peri-interventionally for patients undergoing electroconvulsive therapy for severe depression.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing ECT treatment for depression (including depression as part of bipolar disorder)
* Adult patients (≥18 years)
* Hypnotic agent used is etomidate
* Sufficient understanding of the Dutch language (in judgement of the attending physician or researcher)
* Written informed consent by patient or legal representative

Exclusion Criteria:

* Significant impaired hearing (defined as unable to communicate verbally or listen to music)
* Severe neurological condition (defined as interfering with the ability to process music)
* Patients receiving ECT for treatment of schizophrenic disorders

Primary outcomes:
measure: Presence or absence of postictal agitation
timeFrame: First 30 minutes post-ECT session
Secondary outcomes:
measure: Severity of postictal agitation
timeFrame: First 30 minutes post-ECT session
measure: Duration of postictal agitation
timeFrame: First 30 minutes post-ECT session
measure: Pretreatment anxiety
timeFrame: Directly before and after the 30-minute music or control intervention prior to ECT session
measure: Music listening behavior
timeFrame: Directly before the 30-minute music or control intervention prior to the ECT session
measure: Duration of recovery
timeFrame: Directly after ECT-session, till leaving recovery room and/or medically ready to be discharged, up to 2 hours post-ECT session
measure: Peri-treatment medication requirement
timeFrame: From 24 hours prior to ECT session until leaving the recovery room, up to 2 hours post-ECT session
measure: Cognitive impairment
timeFrame: Within 7 days prior to ECT course and 2 and 90 days after completing ECT course
measure: Severity of depression
timeFrame: Within 7 days prior to ECT course and weekly during the ECT course (up to 4 months)
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Antes Parnassia Group
Study officials:
affiliation: Erasmus Medical Center
name: Markus Klimek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leucht S, Fennema H, Engel RR, Kaspers-Janssen M, Szegedi A. Translating the HAM-D into the MADRS and vice versa with equipercentile linking. J Affect Disord. 2018 Jan 15;226:326-331. doi: 10.1016/j.jad.2017.09.042. Epub 2017 Sep 27.
citation: Graff V, Wingfield P, Adams D, Rabinowitz T. An Investigation of Patient Preferences for Music Played Before Electroconvulsive Therapy. J ECT. 2016 Sep;32(3):192-6. doi: 10.1097/YCT.0000000000000315.
citation: Schuur G, Verdijk JPAJ, Ten Doesschate F, van Wingen GA, van Waarde JA. Severe Postictal Confusion After Electroconvulsive Therapy: A Retrospective Study. J ECT. 2023 Mar 1;39(1):34-41. doi: 10.1097/YCT.0000000000000866. Epub 2022 May 25.
citation: Andrade C, Arumugham SS, Thirthalli J. Adverse Effects of Electroconvulsive Therapy. Psychiatr Clin North Am. 2016 Sep;39(3):513-30. doi: 10.1016/j.psc.2016.04.004. Epub 2016 Jun 25.
citation: Ertman M, van der Valk Bouman ES, Clephas PRD, Birkenhager TK, Klimek M. Prognostic Factors and Incidence for Postictal Agitation After Electroconvulsive Therapy: A Systematic Review and Meta-analysis. J ECT. 2025 Mar 1;41(1):17-26. doi: 10.1097/YCT.0000000000001032. Epub 2024 Aug 22.