Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients

Study Overview
=================
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.

Official Title
-----------------
Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Other: Music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music group<br> | Other: Music<br>* Participant in the intervention group will receive music interventions perioperatively.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |