Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients

Sleep Clinical Trial

— DREAMERS  

Official title:

Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06131034
• Other study ID #: NL78543.078.21
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2023
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: Erasmus Medical Center
• Contact: Roos Geensen, MD
• Phone: +31 10 7040704
• Email: r.geensen[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: May 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep

Intervention

Other:
• Music
Participant in the intervention group will receive music interventions perioperatively.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Area of residence	Using postal code of current address	At baseline
Other	General medication use (incidence and concentration)	Medication use that could be of influence on sleep quality	Before and during admittance, retrospectively, with a maximum of day 30 postoperatively
Other	Physical parameter, bloodpressure	in mm/Hg	During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.
Other	Physical parameter, pulse rate	beats/min	During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.
Other	Physical parameter, respiratory rate	Resp/min	During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.
Other	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.
Other	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.
Primary	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	Subjective sleep quantity	Using the adapted Consensus Sleeping Diary	During the (possible) intervention period, until day 5 postoperatively
Secondary	Objective sleep assessment	Measured with an actigraphy device	During the (possible) intervention period, until day 5 postoperatively
Secondary	Music listening during study period	Using a diary	During the (possible) intervention period, until day 5 postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cost consequences and cost-effectiveness	Using the Institute for Medical Technology Assessment (iMTA) productivity loss questionnaire	30 days after discharge
Secondary	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
Secondary	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.