Clinical trial NCT06131034: Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients
Official title: Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Subjective sleep quality assessed using a questionnaire
timeFrame: On the morning of day 2, 3 and 4 at the surgical ward
Secondary outcomes:
measure: Subjective sleep quantity
timeFrame: During the (possible) intervention period, until day 5 postoperatively
measure: Objective sleep assessment
timeFrame: During the (possible) intervention period, until day 5 postoperatively
measure: Music listening during study period
timeFrame: During the (possible) intervention period, until day 5 postoperatively
measure: Anxiety
timeFrame: Every morning during the (possible) intervention period, until day 5 postoperatively
measure: Subclinical stess using
timeFrame: At baseline and at the end of the (possible) intervention period, at day 5 postoperatively
measure: Postoperative quality of recovery using a questionnaire
timeFrame: At baseline, at the end of the (possible) intervention period (from start of study until day 5 postoperatively) and 30 days after discharge
measure: Patient satisfaction using a self-made questionnaire
timeFrame: At the end of the study period, 30 days after discharge
measure: Music preference and importance in daily life
timeFrame: At baseline
measure: Cost consequences and cost-effectiveness
timeFrame: 30 days after discharge
measure: Cost consequences and cost-effectiveness
timeFrame: 30 days after discharge
measure: Quality of life score
timeFrame: At baseline, at the end of the (possible) intervention period (from start of study until day 5 postoperatively) and 30 days after discharge
measure: Delirium incidence
timeFrame: During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.
Other outcomes:
measure: Area of residence
timeFrame: At baseline
measure: General medication use (incidence and concentration)
timeFrame: Before and during admittance, retrospectively, with a maximum of day 30 postoperatively
measure: Physical parameter, bloodpressure
timeFrame: During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.
measure: Physical parameter, pulse rate
timeFrame: During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.
measure: Physical parameter, respiratory rate
timeFrame: During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.
measure: Perioperative complications
timeFrame: During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.
measure: Clinical information checklist
timeFrame: During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: C. Verhoef, Professor
role: PRINCIPAL_INVESTIGATOR
References: