Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06173674
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2023-11-20
Brief Title:
The Feasibility and Acceptability of a Music Intervention to Reduce Preoperative Anxiety in Older Patients
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
fa-MIPA
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 surgeryTAVI procedure
be evaluated for preoperative anxiety levels and postoperative delirium
be interviewed to learn about their perspectives regarding the music intervention
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 surgeryTAVI 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 inclusionexclusion 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 surgeryprocedure 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 surgeryprocedure 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
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 inclusionexclusion 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 surgeryprocedure 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 surgeryprocedure 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None