Preoperative Anxiety Clinical Trial
— fa-MIPAOfficial 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
NCT number | NCT06173674 |
Other study ID # | S68344 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 4, 2023 |
Est. completion date | April 15, 2024 |
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
Status | Recruiting |
Enrollment | 70 |
Est. completion date | April 15, 2024 |
Est. primary completion date | April 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Leuven | Leuven | Vlaams Brabant |
Lead Sponsor | Collaborator |
---|---|
KU Leuven |
Belgium,
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. — View 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. — View Citation
Stamenkovic DM, Rancic NK, Latas MB, Neskovic V, Rondovic GM, Wu JD, Cattano D. Preoperative anxiety and implications on postoperative recovery: what can we do to change our history. Minerva Anestesiol. 2018 Nov;84(11):1307-1317. doi: 10.23736/S0375-9393.18.12520-X. Epub 2018 Apr 5. — View 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. — View Citation
Williams JB, Alexander KP, Morin JF, Langlois Y, Noiseux N, Perrault LP, Smolderen K, Arnold SV, Eisenberg MJ, Pilote L, Monette J, Bergman H, Smith PK, Afilalo J. Preoperative anxiety as a predictor of mortality and major morbidity in patients aged >70 years undergoing cardiac surgery. Am J Cardiol. 2013 Jan 1;111(1):137-42. doi: 10.1016/j.amjcard.2012.08.060. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reach | The number and proportion of individuals willing to participate will be calculated, and reasons for refusing will be documented. | Recruitment, on average of 1 day | |
Primary | Compliance rate | The compliance rate refers to one session with 20 minutes or more of music intervention on the day before and on the day of surgery/TAVI procedure. | from admission to time just before surgery, on average of 2 days | |
Primary | Acceptability of music intervention | Patients perspective regarding their satisfaction and experience of the music intervention will be asked via a short interview (e.g., Overall, were you satisfied with the music listening before your surgery/procedure? Would you like to listen to music again in a future surgery/procedure?) | After surgery to discharge, on average of 5 days | |
Primary | Patients' preference of music intervention | Patients' preference regarding intervention details including music selection, number of sessions, duration, setting, and implementation time, will be asked via a short interview (e.g., Do you think listening to music 2 times before surgery is enough to reduce anxiety about the surgery/ procedure? When would you prefer to listen to the music?). | After surgery to discharge, on average of 5 days | |
Primary | Barriers of receiving music intervention | Barriers of receiving music intervention will be also asked (e.g., Did you experience any problems while listening to music?). | After surgery to discharge, on average of 5 days | |
Secondary | Preoperative anxiety levels (APAIS-A) | The preoperative anxiety level will be assessed using the anxiety subscale of Amsterdam Preoperative Anxiety and Information Scale (APAIS-A) before and after receiving the music intervention. APAIS-A consists of 4 items, each of which could be scored from 1 to 5. The score of the APAIS-A is the sum of these four questions, with a scoring range from 4 (not anxious) to 20 (highly anxious). | from admission to the day of surgery, on average of 2 days | |
Secondary | Preoperative anxiety levels (STAI-6) | The preoperative anxiety level will be assessed using six-item Dutch version of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI-6) before and after receiving the music intervention. STAI-6 consists of 6 items, each of which could be scored from 1 (not at all) to 4 (very much so). The sum score varies between 6 and 24, with higher scores indicating higher levels of anxiety. | from admission to the day of surgery, on average of 2 days | |
Secondary | Preoperative anxiety levels (VAS-A) | The preoperative anxiety level will be assessed using VAS-A (Visual Analogue Scale for anxiety) before and after receiving the music intervention. The VAS-A consists of a line which is 10 centimeters in length. Patients are asked to mark a cross on the line based on how they feel during a specified moment in time. A mark at the extreme left end indicates that one feeling not at all anxious. A mark at the extreme right end would indicate that you are feeling the most anxious you could ever imagine. | from admission to the day of surgery, on average of 2 days | |
Secondary | Preoperative anxiety levels (short interview) | We will also ask patients a few questions regarding their changes in overall status and negative thoughts specific to surgery after receiving the music intervention (e.g., Did you feel more relaxed after listening to music before the surgery/procedure?). | After surgery to discharge, on average of 5 days | |
Secondary | Incidence of postoperative delirium | The incidence of postoperative delirium during all postoperative days will be assessed using 3D-CAM (3-Minute Diagnostic Interview for Confusion Assessment Method) and checking patients' records for the results of the Delirium Observations Scale performed by the nurses on the ward. Medical records will also be retrospectively reviewed using CHART-DEL (Chart-based Delirium Identification Instrument) to identify postoperative delirium. | After surgery to discharge, on average of 5 days |
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