Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients

NCT06131034 | Unknown

• 1 other identifier: NL78543.078.21
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Subjective sleep quantity

  During the (possible) intervention period, until day 5 postoperatively

• Objective sleep assessment

  During the (possible) intervention period, until day 5 postoperatively

• Music listening during study period

  During the (possible) intervention period, until day 5 postoperatively

• Anxiety

  Every morning during the (possible) intervention period, until day 5 postoperatively

• Subclinical stess using

  At baseline and at the end of the (possible) intervention period, at day 5 postoperatively

Other Outcomes (7)

• Area of residence

  At baseline

• General medication use (incidence and concentration)

  Before and during admittance, retrospectively, with a maximum of day 30 postoperatively

• Physical parameter, bloodpressure

  During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.

Study Arms (2)

Music group

EXPERIMENTAL

Other: Music

Control group

NO INTERVENTION

Interventions

Music OTHER

Participant in the intervention group will receive music interventions perioperatively.

Music group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 CN, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 41326266 DERIVED

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• C. Verhoef, Professor

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roos Geensen, MD

CONTACT

+31 10 7040704; r.geensen@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. C. Verhoef

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: November 14, 2023
• Study Start: August 9, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)