the Effect of a MUsic Intervention on poStictal Agitation in Electroconvulsive Therapy Patients: the MUSE Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Presence or absence of postictal agitation
研究概览
简要总结
This study will investigate the effect of music on postictal agitation when played peri-interventionally for patients undergoing electroconvulsive therapy for severe depression.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the study and the music intervention, it is not possible to blind participants and investigators.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention group, listening to recorded music
Recorded music, with headphones, for 30 minutes directly before ECT and 12 minutes directly after ECT.
干预措施: Intervention group, listening to recorded music (Other)
Control group, headphones with no music
Headphones with no music or sound, for 30 minutes directly before ECT and 12 minutes directly after ECT.
干预措施: Control group, headphones with no music (Other)
结局指标
主要结局
Presence or absence of postictal agitation
时间窗: 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.
次要结局
- Severity of postictal agitation(First 30 minutes post-ECT session)
- Music listening behavior(Directly before the 30-minute music or control intervention prior to the ECT session)
- Peri-treatment medication requirement(From 24 hours prior to ECT session until leaving the recovery room, up to 2 hours post-ECT session)
- Duration of postictal agitation(First 30 minutes post-ECT session)
- Pretreatment anxiety(Directly before and after the 30-minute music or control intervention prior to ECT session)
- 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)
- Cognitive impairment(Within 7 days prior to ECT course and 2 and 90 days after completing ECT course)
- Severity of depression(Within 7 days prior to ECT course and weekly during the ECT course (up to 4 months))
研究者
Markus Klimek
Vice-Charmain Department of Anesthesiology, Director Residency Training Program Department of Anesthesiology
Erasmus Medical Center