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

Erasmus University

Status: Not yet enrolling

Conditions: Agitation on Recovery from Sedation; Music Intervention; Electroconvulsive Therapy Treated Patients

Treatments: Other: Control group, headphones with no music; Other: Intervention group, listening to recorded music

Study type: Interventional

Funder types: Other

Identifiers

NCT06817330

NL86074.078.24

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Intervention group, listening to recorded music

Experimental group

Description:

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

Treatment:

Other: Intervention group, listening to recorded music

Control group, headphones with no music

Other group

Description:

Headphones with no music or sound, for 30 minutes directly before ECT and 12 minutes directly after ECT.

Treatment:

Other: Control group, headphones with no music