The Effect of a Music Intervention on Postictal Agitation in Electroconvulsive Therapy Patients (MUSE)

the Effect of a MUsic Intervention on poStictal Agitation in Electroconvulsive Therapy Patients: the MUSE Trial

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

Study Overview

• Status: Recruiting
• Conditions: Music Intervention; Agitation on Recovery From Sedation; Electroconvulsive Therapy Treated Patients
• Intervention / Treatment: Other: Intervention group, listening to recorded music; Other: Control group, headphones with no music

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.

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emy S van der Valk Bouman, MD; Phone Number: +31107033357; Email: e.vandervalkbouman@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • Recruiting
    • Erasmus Medical Center
    • Contact: Emy S van der Valk Bouman, MD; Phone Number: +31107033357; Email: e.vandervalkbouman@erasmusmc.nl
    • Principal Investigator: Markus Klimek, MD, PhD
  • Rotterdam, Netherlands, 3079 DC
    • Recruiting
    • Antes Parnassia Group
    • Contact: Joris J.B. van der Vlugt, MD, PhD; Phone Number: +31883587600; Email: jorisvdvlugt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group, listening to recorded music; Recorded music, with headphones, for 30 minutes directly before ECT and 12 minutes directly after ECT.	Other: Intervention group, listening to recorded music; Participants in the group receiving music will be offered a tablet with several pre-created playlists. When the patient has made a selection, they will listen to music via headphones for 30 minutes before each ECT treatment session. The headphones will be removed and the music stopped after the 30 minutes. After active ECT treatment, the headphones will be put back on the patient and the music played for another 12 minutes while the patient is recovering and moved to the recovery room. If patients protest against the music and/or headphones, the researcher will ask them to put the headphones back on. If the patient still protests after asking to put the headphones back on, this will be written down by the researcher, with the amount of time without the (control) intervention noted. No coercion will be used during the whole study process.
Other: Control group, headphones with no music; Headphones with no music or sound, for 30 minutes directly before ECT and 12 minutes directly after ECT.	Other: Control group, headphones with no music; The control group will wear headphones without music for the same duration as the music group (30 minutes before ECT and 12 minutes after ECT) to reduce bias and achieve a similar level of background-noise dampening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of postictal agitation	The primary outcome measure is the presence or absence of postictal agitation (PIA). All patients will be screened for PIA using the RASS (Richmond Agitation-Sedation Scale), a 10-point scale, indicating alertness and responsiveness, taking less than 20 seconds to perform. The scale ranges from -5 (deep sedation) to +4 (extreme agitation), with positive scores indicating agitation (higher score is more agitation so worse outcome) relevant for diagnosing PIA. Screening for PIA will be conducted after the first six ECT treatments by a nurse or medical student who will monitor the patient for 30 minutes in the recovery room. PIA is defined as agitation leading to a score of +1 or greater on the RASS during this period. Patients scoring less than +1 will be recorded as having no PIA for that session. Nurses and medical students will receive training on using the RASS scale, documented in the training log and side delegation file.	First 30 minutes post-ECT session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of postictal agitation	All patients will be screened for PIA using the RASS (Richmond Agitation-Sedation Scale), a 10-point scale, indicating alertness and responsiveness, taking less than 20 seconds to perform. The scale ranges from -5 (deep sedation) to +4 (extreme agitation), with positive scores indicating agitation (higher score is more agitation so worse outcome) relevant for diagnosing PIA. Patients will screen positive for PIA if the RASS is at least +1. Mild PIA is characterized by a RASS score of +1, while moderate and severe PIA are indicated by scores of ≥ +2. A RASS score of at least +2 is associated with a greater risk of danger to the patient and/or staff.	First 30 minutes post-ECT session
Duration of postictal agitation	All patients will be screened for PIA using the RASS (Richmond Agitation-Sedation Scale), a 10-point scale, indicating alertness and responsiveness, taking less than 20 seconds to perform. The scale ranges from -5 (deep sedation) to +4 (extreme agitation), with positive scores indicating agitation (higher score is more agitation so worse outcome) relevant for diagnosing PIA. The duration of PIA will be measured as the time from the highest observed RASS score to a RASS score of zero. A longer duration is longer agitation so a worse outcome. PIA duration is a predictor of retrograde amnesia following ECT, with shorter durations being desirable.	First 30 minutes post-ECT session
Pretreatment anxiety	Patients will be screened for pretreatment anxiety using the VAS-A, a validated self-rating measurement ranging from 0 (not at all anxious) to 10 (extremely anxious).	Directly before and after the 30-minute music or control intervention prior to ECT session
Music listening behavior	Before each intervention/ECT session, patients will be asked if and how long they listened to music the day before treatment.	Directly before the 30-minute music or control intervention prior to the ECT session
Duration of recovery	Recovery duration will be measured as the total time spent in the recovery room after ECT. The time that the patient is deemed medically ready to be discharged (but has not yet left) will also be noted.	Directly after ECT-session, till leaving recovery room and/or medically ready to be discharged, up to 2 hours post-ECT session
Peri-treatment medication requirement	Peri-treatment medication requirement includes all medication used from 24 hours before ECT until leaving the recovery room, with dosage corrected for body weight (mg/kg) for medications such as antipsychotics, benzodiazepines, mood stabilizers, and opioids.	From 24 hours prior to ECT session until leaving the recovery room, up to 2 hours post-ECT session
Cognitive impairment	Cognitive impairment will be assessed using the MoCA (Montreal Cognitive Assessment), a scale ranging from 0-30. Lower scores mean more cognitive impairment, so worse outocmes. Anything below 26 is a sign of cognitive impairment. The MoCA will be administered within 7 days before the first ECT treatment (baseline) and during follow-up at 2 and 90 days after the patient's completion of the full ECT course.	Within 7 days prior to ECT course and 2 and 90 days after completing ECT course
Severity of depression	Depression severity will be measured before the start of the ECT course and weekly during the course using the HDRS (Hamilton Depression Rating Scale, range 0-52) or the MADRS (Montgomery-Åsberg Depression Rating Scale, range 0-60). For both scales, higher ratings mean more depression so a worse outcome. To avoid overburdening the severly depressed patients in this study with additional questionnaires, both scales will be used in accordance with standard care procedures at the participating centers. The HDRS and MADRS scales are correlated and can be converted between each other, which will be done during the analysis phase of the study.	Within 7 days prior to ECT course and weekly during the ECT course (up to 4 months)

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Parnassia Groep
• Investigators: Principal Investigator: Markus Klimek, MD, PhD, Erasmus Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• van der Valk Bouman ES, Ertman M, Koopmans MR, van der Vlugt-Molenaar JJB, Heijnen WTCJ, van Groen JC, Korstanje JW, Birkenhager TK, Klimek M. Effect of peri-interventional music on postictal agitation in electroconvulsive therapy patients (MUSE): protocol for an open-label multicentre randomised controlled trial in the Netherlands. BMJ Open. 2025 Dec 10;15(12):e105979. doi: 10.1136/bmjopen-2025-105979.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: music; electroconvulsive therapy; postictal agitation
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Nervous System Diseases; Behavioral Symptoms; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: NL86074.078.24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will only be shared upon request. This decision will be made by the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No