NCT06817330

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2025-11-25
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2025-02-10
• Last updated: 2025-12-17

Locations

2 sites across 1 country: Netherlands