Music Intervention to Reduce Anxiety and Prevent Delirium in Older Adults Undergoing Cardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorKU Leuven
About this trial
The goal of this clinical trial is to evaluate the effectiveness of the music intervention in preventing postoperative delirium (POD) in older patients undergoing elective cardiac surgery.
The primary question is: Among older adults undergoing elective cardiac surgery, does offering a structured perioperative music intervention in addition to standard care reduce the incidence of POD within the first five postoperative days compared with standard care alone? The secondary questions are: Does perioperative music intervention reduce preoperative anxiety (PA) among older patients undergoing cardiac surgery, and does the level of PA moderate the effect of the music intervention on POD?
Researchers will compare music intervention to routine care to see if music intervention can reduce PA and prevent POD.
Participants will listen to music before and after surgery, be assessed for PA and POD, and participate in an interview about participants' perspectives on the music intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary written informed consent of the participant or the participant's legally authorized representative has been obtained prior to any screening procedures
At least 65 years of age at the time of signing the Informed Consent Form (ICF)
Scheduled for elective cardiac surgery.
Able to participate and communicate in Dutch.
Disqualifiers
Participant has a history of music-induced seizures.
Inability to use headphones or smartphones.
Deafness or severe hearing impairment, defined as being unable to listen to music.
Presence of delirium at baseline, as screened with the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM).
Trial design
Design model
Parallel
Treatments tested in this trial
Music Intervention Group
Other interventionParticipants will receive eight perioperative music sessions in addition to standard care. Each session will last approximately 20-30 minutes. Two sessions will be provided preoperatively (on the evening before surgery and on the morning of surgery), followed by six postoperative sessions (one in the recovery room and one daily from postoperative day 1 to day 5). Music will be delivered via smartphones and wireless headphones using participant-selected playlists on Spotify. A trained research nurse will provide instructions and assistance with the equipment. The number and duration of completed sessions will be documented.
Treatment groups
256 Participants
are divided into 2 treatment groupsGroup A: Music intervention groupExperimental treatment 1 intervention
Group B: Routine careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
POD incidence
The occurrence of POD will be assessed once daily by research nurses from postoperative day 1 until postoperative day 5 using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM). The 3D-CAM consists of patient interviews, cognitive testing, and observer ratings. To decide whether a patient has developed POD, the standard Confusion Assessment Method (CAM) diagnostic algorithm is applied. A positive POD diagnosis is confirmed if the following features are present: 1) acute onset or fluctuating course, and 2) inattention, and 3) either disorganized thinking or 4) altered level of consciousness. Additionally, patients' records will be reviewed using the Chart-based Delirium Identification Instrument (CHART-DEL).
Time frame
Daily on postoperative days 1 through 5, or until hospital discharge, whichever occurs first.Secondary outcomes
1
Preoperative anxiety assessed by the Amsterdam Preoperative Anxiety and Information Scale
The preoperative anxiety level will be assessed using the anxiety subscale of the Amsterdam Preoperative Anxiety and Information Scale (APAIS-A) before and after receiving the music intervention. APAIS-A consists of 4 items; each item is scored from 1 to 5. The APAIS-A score is the sum of the four item scores, with a scoring range from 4 (not anxious) to 20 (highly anxious).
Time frame
From admission to the day of surgery, an average of 2 days2
Preoperative anxiety assessed by the Visual Analogue Scale for Anxiety
The Visual Analogue Scale for Anxiety (VAS-A) is a 100-millimeter (mm) horizontal line anchored by "not at all anxious" at 0 mm and "most anxious imaginable" at 100 mm. Participants will mark the point on the line that best reflects the current level of anxiety.
Time frame
From admission to the day of surgery, an average of 2 days3
The severity of postoperative delirium (3D-CAM-S)
The severity of POD will be assessed daily from postoperative day 1 to postoperative day 5 using the 3-Minute Diagnostic Interview for Confusion Assessment Method-defined Delirium Severity (3D-CAM-S). The 3D-CAM-S raw severity score ranges from 0 to 20 points. Higher scores on both scales indicate greater delirium severity.
Time frame
Daily on postoperative days 1 through 5, or until hospital discharge, whichever occurs first.4
The severity of postoperative delirium (DOSS)
The severity of POD will be assessed daily from postoperative day 1 to postoperative day 5 using the Delirium Observation Screening Scale (DOSS). The DOSS score ranges from 0 to 13 points. Higher scores on both scales indicate greater delirium severity.
Time frame
Daily on postoperative days 1 through 5, or until hospital discharge, whichever occurs first. Source ClinicalTrials.gov
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