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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06817330
• Lead Sponsor: Erasmus Medical Center

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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Start: 2025-03-01
• Primary Completion: 2027-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Presence or absence of postictal agitation	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.

Secondary Outcome Measures

Name	Time	Method
Severity of postictal agitation	First 30 minutes post-ECT session	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.
Music listening behavior	Directly before the 30-minute music or control intervention prior to the ECT session	Before each intervention/ECT session, patients will be asked if and how long they listened to music the day before treatment.
Peri-treatment medication requirement	From 24 hours prior to ECT session until leaving the recovery room, up to 2 hours post-ECT session	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.
Duration of postictal agitation	First 30 minutes post-ECT session	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.
Pretreatment anxiety	Directly before and after the 30-minute music or control intervention prior to ECT session	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).
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	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.
Cognitive impairment	Within 7 days prior to ECT course and 2 and 90 days after completing ECT course	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.
Severity of depression	Within 7 days prior to ECT course and weekly during the ECT course (up to 4 months)	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.

Trial Locations

Locations (2)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Antes Parnassia Group; 🇳🇱 Rotterdam, Netherlands