The Feasibility and Acceptability of a Music Intervention to Reduce Preoperative Anxiety in Older Patients

NCT06173674 | Completed

• 1 other identifier: S68344
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Preoperative Care; Preoperative Anxiety

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Preoperative anxiety levels (APAIS-A)

  from admission to the day of surgery, on average of 2 days

• Preoperative anxiety levels (STAI-6)

  from admission to the day of surgery, on average of 2 days

• Preoperative anxiety levels (VAS-A)

  from admission to the day of surgery, on average of 2 days

• Preoperative anxiety levels (short interview)

  After surgery to discharge, on average of 5 days

• Incidence of postoperative delirium

  After surgery to discharge, on average of 5 days

Study Arms (1)

Music intervention

EXPERIMENTAL

The music intervention will consist of three components, including 1) playlist composition, 2) music intervention delivery, and 3) cleaning or disinfection of the equipment.

Other: Music intervention

Interventions

Music intervention OTHER

The music intervention will consist of three components including: 1. Playlist composition Six music genres playlists will be offered to patients, including Classical Music, Country Music, Folk Music, Hymns and Reglious Music, Jazz and Swing Music, Popular/Easy Listening/RNB and Soundtrack Music. Patients can also add their favourite music to the list as well. 2. Music Intervention Delivery The general criteria for intervention delivery are:1) Each session lasts at least 20 minutes; 2) The music will be delivered by a comfortable, wireless, on/off switch noise-cancelling headphone; 3) The volume will be adjusted according to the patient's preference and controlled at 65dB or lower; 4) The order of music in the playlists will be decided by the patient; 5) Music will be delivered in inpatient room and/or waiting area before surgery/procedure. 3. Cleaning and infection of the equipment We will comply with guidelines on disinfection of materials in the hospital.

Music intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospital Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (6)

• 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.

  PMID: 36997928 BACKGROUND

• 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.

  PMID: 29624026 BACKGROUND

• 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.

  PMID: 23245838 BACKGROUND

• 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.

  PMID: 35480569 BACKGROUND

• 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.

  PMID: 37149743 BACKGROUND

• 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.

  PMID: 23740695 BACKGROUND

Study Officials

• Koen Milisen, PhD

  Department of Public Health and Primary Care, Academic Centre for Nursing and Midwifery, KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 18, 2023
• Study Start: December 4, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: On reasonable request
• Access Criteria: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. As far as requests are in line with the scope and research objectives of the fa-MIPA study.

Locations

BE (1)