Postictal agitation (PIA) is a common adverse effect following electroconvulsive therapy (ECT). Current pharmacological treatments for PIA have undesirable side effects, and interventions to prevent PIA are unsatisfactory. The aim of this study is to assess the effect of peri-interventional music on PIA for patients undergoing ECT. Additionally, the study will assess the impact of music on pretreatment anxiety and post-treatment cognitive impairment.
This multicentre, open-label, parallel randomised controlled trial (RCT) aims to include 92 patients from two centres in Rotterdam, the Netherlands. Participants will be randomised into two groups: a music intervention group and a control group. The music group listens to recorded music 30 min before and 12 min after each of the first six ECT sessions of the full ECT course, while the control group will receive standard care. The primary outcome is the presence of PIA, measured using the Richmond Agitation-Sedation Scale (RASS). Secondary outcomes include the severity and duration of PIA, pretreatment anxiety, recovery duration, peri-treatment medication requirements, cognitive impairment and depression severity. Data will be analysed according to an intention-to-treat principle.
This study protocol has been approved by the Medical Ethical Review Committee of the Erasmus Medical Centre on 28 January 2025 (MEC-2024–0467) and subsequently received local approval at Antes Parnassia group. The trial will be carried out following the Declaration of Helsinki principles. Study results will be reported in a peer-reviewed journal according to the Consolidated Standards of Reporting Trials guidelines.
Regular physical exercise has well-known health benefits and is generally considered safe for adults with congenital heart disease (ACHD). However, many individuals with ACHD remain insufficiently physically active. This study explored the barriers and needs related to physical exercise as experienced by people with ACHD to inform the development of tailored strategies that support and promote increased physical activity.
Qualitative study using semistructured interviews conducted between March and May 2023. The interview guide was based on the Fear Avoidance Model, Tampa Scale for Kinesiophobia Heart and European Society of Cardiology guidelines on sports cardiology and exercise for cardiovascular diseases. Interviews were coded and thematically analysed to identify specific physical exercise barriers and needs.
Data saturation was reached after interviewing 19 individuals living with ACHD (median age 46 years (range 24–75), 10 women). Thematic analysis identified four main barriers: (1) physical symptoms and negative past experiences, (2) alienation from peers, (3) perceived decline in physical fitness over time and (4) lack of knowledge about personal physical boundaries. Two needs were identified: (1) personalised, disease-specific exercise information and advice and (2) structured support and guidance from healthcare professionals.
People with ACHD face multiple barriers to engaging in physical exercise. There is a clear need for specific, personalised exercise advice from healthcare providers and the development of long-term programmes and interventions to overcome relevant barriers.