Music InterventionMUSENCT06817330
The Effect of a Music Intervention on Postictal Agitation in Electroconvulsive Therapy Patients
A study testing Intervention group, listening to recorded music in people with Music Intervention and Electroconvulsive Therapy Treated Patients, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial summary
This study will investigate the effect of music on postictal agitation when played peri-interventionally for patients undergoing electroconvulsive therapy for severe depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Music Intervention, Electroconvulsive Therapy Treated Patients, Agitation on Recovery From Sedation
- What is being tested?
- Intervention group, listening to recorded music
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesNetherlands
- Study dates
- 25 Nov 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, 3015 GD
Emy S van der Valk Bouman, MD, +31107033357, e.vandervalkbouman@erasmusmc.nl
Markus Klimek, MD, PhD
- Recruiting
Antes Parnassia Group
Rotterdam, 3079 DC
Joris J.B. van der Vlugt, MD, PhD, +31883587600, jorisvdvlugt@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Music Intervention, Electroconvulsive Therapy Treated Patients, Agitation on Recovery From Sedation
- Being tested
- Intervention group, listening to recorded music, Control group, headphones with no music
- Keywords
- music, postictal agitation, electroconvulsive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group, listening to recorded musicOther
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.
Control group, headphones with no musicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group, listening to recorded music | Experimental | Recorded music, with headphones, for 30 minutes directly before ECT and 12 minutes directly after ECT. Receives: 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. Receives: Other: Control group, headphones with no music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 30 minutes post-ECT session
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 7 days prior to ECT course and weekly during the ECT course (up to 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start25 Nov 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Music InterventionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center prospective randomized controlled trial with a parallel design.
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Parnassia Groep
- Responsible party
- Principal investigator, Markus Klimek, Erasmus Medical Center
- Investigators
- Markus Klimek, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817330
- Sponsor's protocol ID
- NL86074.078.24
- Acronym
- MUSE
- Status last verified
- Dec 2025
- First submitted
- 29 Jan 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be shared upon request. This decision will be made by the principal investigator.
Publications
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.
PubMed 29031182Graff 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.
PubMed 27075143Schuur 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.
PubMed 36825989Andrade 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.
PubMed 27514303Ertman 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.
PubMed 39105589van 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.
PubMed 41371746
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of a MUsic Intervention on poStictal Agitation in Electroconvulsive Therapy Patients: the MUSE Trial
- ClinicalTrials.gov ID
- NCT06817330
- Acronym / sponsor ID
- MUSE / NL86074.078.24
- Conditions
- Music Intervention, Electroconvulsive Therapy Treated Patients, Agitation on Recovery From Sedation
- Keywords
- music, postictal agitation, electroconvulsive therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Parnassia Groep
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-center prospective randomized controlled trial with a parallel design.
| Arm | Type | Receives |
|---|---|---|
| Intervention group, listening to recorded music | Experimental | Other: Intervention group, listening to recorded musicRecorded music, with headphones, for 30 minutes directly before ECT and 12 minutes directly after ECT. |
| Control group, headphones with no music | Other | Other: Control group, headphones with no musicHeadphones with no music or sound, for 30 minutes directly before ECT and 12 minutes directly after ECT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group, listening to recorded musicParticipants 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 | Intervention group, listening to recorded music |
| Control group, headphones with no musicThe 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. | Other | Control group, headphones with no music |
Primary outcome
Presence or absence of postictal agitation
Time frame: First 30 minutes post-ECT session
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.
8 secondary outcomes
Severity of postictal agitation
Time frame: First 30 minutes post-ECT session
Duration of postictal agitation
Time frame: First 30 minutes post-ECT session
Pretreatment anxiety
Time frame: Directly before and after the 30-minute music or control intervention prior to ECT session
Music listening behavior
Time frame: Directly before the 30-minute music or control intervention prior to the ECT session
Duration of recovery
Time frame: 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
Time frame: From 24 hours prior to ECT session until leaving the recovery room, up to 2 hours post-ECT session
Cognitive impairment
Time frame: Within 7 days prior to ECT course and 2 and 90 days after completing ECT course
Severity of depression
Time frame: Within 7 days prior to ECT course and weekly during the ECT course (up to 4 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 29031182Leucht 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.
- Background: PubMed 27075143Graff 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.
- Background: PubMed 36825989Schuur 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.
- Background: PubMed 27514303Andrade 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.
- Background: PubMed 39105589Ertman 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.
- Derived from this study: PubMed 41371746van 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.
- Individual participant dataSharing planned: No. Data will only be shared upon request. This decision will be made by the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Markus Klimek, MD, PhD principal investigator
Erasmus Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group, listening to recorded music in people with Music Intervention and Electroconvulsive Therapy Treated Patients, run by Erasmus Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emy S van der Valk Bouman, MD (+31107033357, e.vandervalkbouman@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of postictal agitation (time frame: First 30 minutes post-ECT session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06817330, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.