Clinical trial NCT06173674: The Feasibility and Acceptability of a Music Intervention to Reduce Preoperative Anxiety in Older Patients
Official title: The Feasibility and Acceptability of a Music Intervention to Reduce Preoperative Anxiety (Fa-MIPA Study) in Older Patients Undergoing Cardiac Surgery or Transcatheter Aortic Valve Implantation (TAVI) Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Care
Preoperative Anxiety
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 78
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical feasibility study is to learn about the acceptability and feasibility of a music intervention in older patients undergoing cardiac surgery and Transcatheter Aortic Valve Implantation (TAVI) procedure.

The primary question it aims to answer is:

• What is the feasibility and acceptability of a music intervention to reduce PA in older patients undergoing cardiac surgery and TAVI?

The secondary question is:

• What is the effect of a music intervention on PA levels and the incidence of POD in older patients undergoing cardiac surgery and TAVI?

Participants will

* listen to music before the surgery/TAVI procedure
* be evaluated for preoperative anxiety levels and postoperative delirium
* be interviewed to learn about their perspectives regarding the music intervention

Detailed description: Background: High levels of preoperative anxiety (PA) have been associated with several complications, including hemodynamic instability, increased intraoperative requirements for anaesthetics, increased risk of postoperative pain, and in some studies an increased incidence of postoperative delirium (POD). Especially for people with reduced physiological reserves such as older patients, PA can independently heighten the risk of mortality or major morbidity. Music intervention stands out as an effective and practical non-pharmacologic intervention on reducing PA levels. Current evidence has proven the effectiveness of music interventions in reducing preoperative anxiety levels; however, the patients' attitudes, preferences, and overall experience of receiving music intervention before surgery are insufficiently explored. Consequently, the investigation of the acceptability of a music intervention among older patients waiting for surgery or other medical procedures is important, as acceptability has emerged as a pivotal factor in the development, assessment, and implementation of a healthcare intervention. Furthermore, it is essential to assess the feasibility of implementing music intervention within the target population, thereby enhancing the overall acceptability of this intervention.

Objectives: The primary objective is to assess the feasibility and acceptability of a music intervention in reducing PA in older patients undergoing cardiac surgery and Transcatheter Aortic Valve Implantation (TAVI) procedure. The secondary objective is to test the effect of the music intervention on preoperative anxiety reduction and the incidence of POD in the target population. Moreover, this study will provide reference for the design of a future randomized controlled trial investigating the relationship between PA and POD in older cardiac surgical patients.

Setting: This feasibility study will be conducted in the Department of Cardiology and Department of Cardiovascular Surgery of the University Hospitals Leuven.

Overall methodology: All potential patients will be identified from the list of patients scheduled for surgery or procedure, and they will be assessed for eligibility after agreeing to participate in this study. They will be provided with an information leaflet with the purpose, process, and potential benefits and harms of this study, as well as the commitment to confidentiality and freedom to withdraw at any time without any consequence. Only the patients willing to participate in the study will be further evaluated to determine their adherence to the inclusion/exclusion criteria. For the eligible patients, we will perform the baseline assessment immediately after obtaining written informed consent from patients.

After admission to hospital, patients will receive music intervention before or during surgery/procedure and perioperative routine postoperative care until discharge. We will assess the preoperative anxiety levels of the patient using validated questionnaires at the baseline and after the music intervention, as well as their perspectives regarding the acceptability and feasibility of music intervention via short interview. Any adverse outcomes related to surgery/procedure or music interventions will also be collected.

In light of feasibility nature of our study, a power calculation is deemed unnecessary, and a sufficient sample size of 30-50, accounting for a 20% attrition rate due to short stays before surgery, leads to a planned minimum recruitment of 70 patients. Four trained study nurses will collect the data under the supervision of PhD student and the promotors. All the data will be firstly collected manually by study nurses, and then will be entered and maintained in the Research Electronic Data Capture (REDCap) database.

Descriptive statistics of demographical information, clinical data, and feasibility and acceptability data will be analysed using suitable numerical and graphical summaries for quantitative data. Paired Samples T-Test will be used for preoperative anxiety level changes before and after the music intervention. The difference of incidence of POD between the group with PA reduction and group without PA reduction will be tested using Chi-squared test. The qualitative data will be analyzed using thematic analysis.

Eligibility criteria: Inclusion Criteria:

* Patients being 60 years or older, scheduled for elective cardiac surgery and Transcatheter Aortic Valve Implantation (TAVI);
* being capable and willing to participate in the study.

Exclusion Criteria:

* cannot use headphones;
* have a history of music-induced seizures;
* have deafness or severe ear diseases such as acute otitis media, eardrum rupture, tinnitus, ear infections, etc.;
* admitted on the day of cardiac surgery;
* have an expected hospital stay of less than 24 hours or a planned intensive care unit stay postoperatively for longer than one day;
* have severe postoperative complications and are unable to be interviewed;
* are currently diagnosed with major psychiatric disease (such as, major depression, generalized anxiety disorder) and dementia as identified in the history of patients file;
* have pre-operative delirium

Primary outcomes:
measure: Reach
timeFrame: Recruitment, on average of 1 day
measure: Compliance rate
timeFrame: from admission to time just before surgery, on average of 2 days
measure: Acceptability of music intervention
timeFrame: After surgery to discharge, on average of 5 days
measure: Patients' preference of music intervention
timeFrame: After surgery to discharge, on average of 5 days
measure: Barriers of receiving music intervention
timeFrame: After surgery to discharge, on average of 5 days
Secondary outcomes:
measure: Preoperative anxiety levels (APAIS-A)
timeFrame: from admission to the day of surgery, on average of 2 days
measure: Preoperative anxiety levels (STAI-6)
timeFrame: from admission to the day of surgery, on average of 2 days
measure: Preoperative anxiety levels (VAS-A)
timeFrame: from admission to the day of surgery, on average of 2 days
measure: Preoperative anxiety levels (short interview)
timeFrame: After surgery to discharge, on average of 5 days
measure: Incidence of postoperative delirium
timeFrame: After surgery to discharge, on average of 5 days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams Brabant
Study officials:
affiliation: Department of Public Health and Primary Care, Academic Centre for Nursing and Midwifery, KU Leuven
name: Koen Milisen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang KL, Detroyer E, Van Grootven B, Tuand K, Zhao DN, Rex S, Milisen K. Association between preoperative anxiety and postoperative delirium in older patients: a systematic review and meta-analysis. BMC Geriatr. 2023 Mar 30;23(1):198. doi: 10.1186/s12877-023-03923-0.
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citation: Wang R, Huang X, Wang Y, Akbari M. Non-pharmacologic Approaches in Preoperative Anxiety, a Comprehensive Review. Front Public Health. 2022 Apr 11;10:854673. doi: 10.3389/fpubh.2022.854673. eCollection 2022.
citation: Aguero-Millan B, Abajas-Bustillo R, Ortego-Mate C. Efficacy of nonpharmacologic interventions in preoperative anxiety: A systematic review of systematic reviews. J Clin Nurs. 2023 Sep;32(17-18):6229-6242. doi: 10.1111/jocn.16755. Epub 2023 May 6.
citation: Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.