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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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 patien
• Другое 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.

Первичные конечные точки

• Presence or absence of postictal agitation [Срок оценки: First 30 minutes post-ECT session]

Вторичные конечные точки (8)

• Severity of postictal agitation [Срок оценки: First 30 minutes post-ECT session]
• Duration of postictal agitation [Срок оценки: First 30 minutes post-ECT session]
• Pretreatment anxiety [Срок оценки: Directly before and after the 30-minute music or control intervention prior to ECT session]
• Music listening behavior [Срок оценки: Directly before the 30-minute music or control intervention prior to the ECT session]
• Duration of recovery [Срок оценки: 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 [Срок оценки: From 24 hours prior to ECT session until leaving the recovery room, up to 2 hours post-ECT session]
• Cognitive impairment [Срок оценки: Within 7 days prior to ECT course and 2 and 90 days after completing ECT course]
• Severity of depression [Срок оценки: Within 7 days prior to ECT course and weekly during the ECT course (up to 4 months)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 2 центра

• Erasmus Medical Center — Rotterdam
• Antes Parnassia Group — Rotterdam

Публикации

• 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
• 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
• 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
• 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
• 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
• 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-2025-1 PMID 41371746

Идентификаторы

NCT: NCT06817330 · NL86074.078.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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