Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients
- Conditions
- Sleep
- Interventions
- Other: Music
- Registration Number
- NCT06131034
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Sleep disturbances are known to be a prevalent problem in hospitalized, surgical patients, which is of importance since sleep disturbances can lead to a range of negative health outcomes. Music interventions have shown potential in improving sleep quality. Unfortunately, the studies on the effect of music on sleep in surgical patient populations are still scarce and of low quality. Therefore, the aim of this study is to study the effect of music on sleep quality in oncological, gastro-intestinal surgical patients in the form of a randomized controlled trial. Participants will be divided in 2 groups, a music group and a control group, where the music group will receive music interventions perioperatively. The researchers will compare both groups to see if there is a difference in sleep quality.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
- Patients aged 18 years or older
- Patients undergoing major elective abdominal surgery for malignant disease, including, but not limited to: Esophageal, gastric, colorectal, hepatic, pancreatic, gynecological and urological surgical procedures.
- Sufficient knowledge of the Dutch language.
- Communicable and able to assess the questionnaires
- Written informed consent acquired from the patient.
- Patients with severe hearing impairment (defined as no or barely verbal communication possible).
- The patient is expected to be transferred to another hospital postoperatively.
- Participation in another study that may possibly intervene with the outcome measures. (e.g. in trial use of sleep medication, interventions regarding sleep quality or quantity or similar procedures)
- Assessment of primary outcome is not possible.
- Inability or unwillingness to receive the music intervention.
- Inability to wear the actigraphy device, or inability to perform actigraphy measurement due to paralysis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Music group Music -
- Primary Outcome Measures
Name Time Method Subjective sleep quality assessed using a questionnaire On the morning of day 2, 3 and 4 at the surgical ward Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance questionnaire, raw summary score
- Secondary Outcome Measures
Name Time Method Objective sleep assessment During the (possible) intervention period, until day 5 postoperatively Measured with an actigraphy device
Anxiety Every morning during the (possible) intervention period, until day 5 postoperatively Using the The State-Trait Anxiety Inventory-6 (STAI-6), 20-80, with a high score being a worse outcome
Subjective sleep quantity During the (possible) intervention period, until day 5 postoperatively Using the adapted Consensus Sleeping Diary
Music listening during study period During the (possible) intervention period, until day 5 postoperatively Using a diary
Subclinical stess using At baseline and at the end of the (possible) intervention period, at day 5 postoperatively Using the Subclinical Stress Symptoms Questionnaire (SSQ-25).
Postoperative quality of recovery using a questionnaire At baseline, at the end of the (possible) intervention period (from start of study until day 5 postoperatively) and 30 days after discharge Quality of Recovery-40 score (QOR-40)
Patient satisfaction using a self-made questionnaire At the end of the study period, 30 days after discharge A Likert scale will be used, 0 -10, with a higher score meaning a more satisfied feeling regarding the hospital admittance.
Music preference and importance in daily life At baseline Using a questionnaire with use of multiple chose questions and a Likert scale, 0 - 10, with a higher score resulting in a more positive attitude towards music
Delirium incidence During the entire hospital stay surrounding the surgery, up to day 30 postoperatively. Delirium Observation Scale per day and delirium diagnosis (defined as diagnosis by clinician)
Cost consequences and cost-effectiveness 30 days after discharge Using the Institute for Medical Technology Assessment (iMTA) productivity loss questionnaire
Quality of life score At baseline, at the end of the (possible) intervention period (from start of study until day 5 postoperatively) and 30 days after discharge Using the EuroQol-5dimension-5length (EQ-5D-5L), with a score of 0 - 100, where a higher score
Trial Locations
- Locations (1)
Erasmus Medical Center
🇳🇱Rotterdam, Zuid-Holland, Netherlands