Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-09

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery

NCT05982184

Cancer of Colon Surgery Anxiety

COMPLETED NA

EffectS of prEferred Music on Laparoscopic performancE

NCT04111679

Laparoscopic Surgery Music Surgical Education

COMPLETED NA

Perioperative Music Listening on Anxiety, Pain, Analgesia Use and Patient Satisfaction

NCT03415620

Music Pain Anxiety +2 more

RECRUITING NA

Perioperative Music Listening on Anxiety, Analgesia Use and Patient Satisfaction

NCT03226028

Music Pain Anxiety +2 more

ACTIVE_NOT_RECRUITING NA

Effect of Music Therapy on the Quality of Recovery

NCT06874972

Music Therapy Music Therapy for Pain and Sedation Postoperative Period +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Music group

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Participant in the intervention group will receive music interventions perioperatively.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Music

Participant in the intervention group will receive music interventions perioperatively.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No