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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music group | Experimental |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music | Other | Participant in the intervention group will receive music interventions perioperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective sleep quality assessed using a questionnaire | Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance questionnaire, raw summary score | On the morning of day 2, 3 and 4 at the surgical ward |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective sleep quantity | Using the adapted Consensus Sleeping Diary | During the (possible) intervention period, until day 5 postoperatively |
| Objective sleep assessment | Measured with an actigraphy device |
| Measure | Description | Time Frame |
|---|---|---|
| Area of residence | Using postal code of current address | At baseline |
| General medication use (incidence and concentration) | Medication use that could be of influence on sleep quality |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roos Geensen, MD | Contact | +31 10 7040704 | r.geensen@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| C. Verhoef, Professor | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | South Holland | 3015 CN | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41326266 | Derived | Stoop JM, Geensen R, Louter M, Poley MJ, Verhoef C, Jeekel J, Klimek M. The DREAMERS-trial: A randomized controlled trial protocol addressing the use of perioperative music to prevent sleep disturbances in hospitalized surgical patients. Contemp Clin Trials. 2025 Dec;159:108129. doi: 10.1016/j.cct.2025.108129. Epub 2025 Oct 24. |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| During the (possible) intervention period, until day 5 postoperatively |
| Music listening during study period | Using a diary | During the (possible) intervention period, until day 5 postoperatively |
| Anxiety | Using the The State-Trait Anxiety Inventory-6 (STAI-6), 20-80, with a high score being a worse outcome | Every morning during the (possible) intervention period, until day 5 postoperatively |
| Subclinical stess using | Using the Subclinical Stress Symptoms Questionnaire (SSQ-25). | At baseline and at the end of the (possible) intervention period, at day 5 postoperatively |
| Postoperative quality of recovery using a questionnaire | Quality of Recovery-40 score (QOR-40) | At baseline, at the end of the (possible) intervention period (from start of study until day 5 postoperatively) and 30 days after discharge |
| Patient satisfaction using a self-made questionnaire | A Likert scale will be used, 0 -10, with a higher score meaning a more satisfied feeling regarding the hospital admittance. | At the end of the study period, 30 days after discharge |
| Music preference and importance in daily life | 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 | At baseline |
| Cost consequences and cost-effectiveness | Using the Institute for Medical Technology Assessment (iMTA) medical consumption questionnaire and the iMTA productivity loss questionnaire | 30 days after discharge |
| Cost consequences and cost-effectiveness | Using the Institute for Medical Technology Assessment (iMTA) productivity loss questionnaire | 30 days after discharge |
| Quality of life score | Using the EuroQol-5dimension-5length (EQ-5D-5L), with a score of 0 - 100, where a higher score | At baseline, at the end of the (possible) intervention period (from start of study until day 5 postoperatively) and 30 days after discharge |
| Delirium incidence | Delirium Observation Scale per day and delirium diagnosis (defined as diagnosis by clinician) | During the entire hospital stay surrounding the surgery, up to day 30 postoperatively. |
| Before and during admittance, retrospectively, with a maximum of day 30 postoperatively |
| Physical parameter, bloodpressure | in mm/Hg | During the entire hospital stay surrounding the surgery, up to day 30 postoperatively. |
| Physical parameter, pulse rate | beats/min | During the entire hospital stay surrounding the surgery, up to day 30 postoperatively. |
| Physical parameter, respiratory rate | Resp/min | During the entire hospital stay surrounding the surgery, up to day 30 postoperatively. |
| Perioperative complications | Number of patients with medical complications, and grading of these complications using Clavien Dindo and the Comprehensive Complication Index (CCI) | During the entire hospital stay surrounding the surgery, up to day 30 postoperatively. |
| Clinical information checklist | Information about type of surgery, selected medical history, age, gender, hospital length of stay | During the entire hospital stay surrounding the surgery, up to day 30 postoperatively. |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |