The DREAMERS-trial: A randomized controlled trial protocol addressing the use of perioperative music to prevent sleep disturbances in hospitalized surgical patients.

BACKGROUND

Sleep disturbances occur in up to 64 % of hospitalized surgical patients, whilst poor sleep impedes postoperative recovery, e.g. through prolonged immobilization due to fatigue. Common treatment with benzodiazepines, however, is associated with serious side effects, among which an increased risk of cognitive impairment, respiratory depression, agitation, and falls leading to fractures. Music is a potential non-pharmacological treatment option without such adverse events, that has already been proven to reduce pain, anxiety and stress. It is therefore investigated on its effectiveness in improving sleep quality in the perioperative period. We hypothesize that a music intervention is effective in improving perioperative sleep quality.

METHODS

A single-center randomized controlled trial is conducted in adult patients, undergoing major gastro-intestinal oncological surgery. Patients in the music group will listen to patient-preferred music through headphones intra-operatively, and postoperatively until postoperative day 4. Patients in the control group will receive standard care. The primary outcome is subjective sleep quality, as assessed with the adapted Patient Reported Outcomes Measurements Information Questionnaire. Secondary outcomes include objective sleep quality, subjective sleep quantity, anxiety, subjective stress, and postoperative recovery. Furthermore, music quantity, patient satisfaction, and music importance and preference will be documented. Patient characteristics, information regarding the current hospital admission and physical parameters, including pain scores and the postoperative risk on delirium, are extracted from the electronic patient records, and cost-effectiveness questionnaires are conducted for economic evaluation of the intervention.

TRIAL REGISTRATION NUMBER: NL78543.078.21, NCT06131034.