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

NCT06817330 | Recruiting

• 1 other identifier: NL86074.078.24
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

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.

Conditions

Music Intervention; Electroconvulsive Therapy Treated Patients; Agitation on Recovery From Sedation

Keywords

music; postictal agitation; electroconvulsive therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Severity of postictal agitation

  First 30 minutes post-ECT session

• Duration of postictal agitation

  First 30 minutes post-ECT session

• Pretreatment anxiety

  Directly before and after the 30-minute music or control intervention prior to ECT session

• Music listening behavior

  Directly before the 30-minute music or control intervention prior to the ECT session

• Duration of recovery

  Directly after ECT-session, till leaving recovery room and/or medically ready to be discharged, up to 2 hours post-ECT session

Study Arms (2)

Intervention group, listening to recorded music

EXPERIMENTAL

Recorded music, with headphones, for 30 minutes directly before ECT and 12 minutes directly after ECT.

Other: Intervention group, listening to recorded music

Control group, headphones with no music

OTHER

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

Interventions

Intervention group, listening to recorded music OTHER

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.

Intervention group, listening to recorded music

Control group, headphones with no music OTHER

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.

Control group, headphones with no music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Parnassia Groep: collaborator

Study Sites (2)

Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands

RECRUITING

Antes Parnassia Group

Rotterdam, 3079 DC, Netherlands

RECRUITING

Related Publications (6)

• 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.

  PMID: 29031182 BACKGROUND

• 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.

  PMID: 27075143 BACKGROUND

• 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.

  PMID: 36825989 BACKGROUND

• 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.

  PMID: 27514303 BACKGROUND

• 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.

  PMID: 39105589 BACKGROUND

• 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.

  PMID: 41371746 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Markus Klimek, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emy S van der Valk Bouman, MD

CONTACT

+31107033357; e.vandervalkbouman@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the study and the music intervention, it is not possible to blind participants and investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Charmain Department of Anesthesiology, Director Residency Training Program Department of Anesthesiology

Model Details: Multi-center prospective randomized controlled trial with a parallel design.

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 10, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)