None listed
Conditions
Brief summary
Rationale: Coronary angiography is the gold standard test for identifying the presence of significant coronary artery disease, however the procedure is invasive and has risks which drive anxiety, pain and discomfort for patients. Many operators routinely use conscious sedation during invasive procedures including coronary angiography and device insertions, to help mitigate these symptoms. Important risks associated with these pharmacological agents, including respiratory depression, nausea and vomiting, hypotension, paradoxical agitation and post- procedural delirium. In light of these, options for non- pharmacological methods of anxiolysis are increasingly being considered as an adjunct to current practice. Music in the catheter laboratory can be used to create a more relaxed clinical environment, which in turn can help to put the patient at ease. This study aims to investigate whether playing music in the catheter laboratory can reduce patient anxiety and improve the overall patient experience The objective of this study is to determine whether and how the use of music in the catheter laboratory influences the patient experience. The study design is a prospective randomised controlled trial. The study population consists of participants undergoing best practice coronary angiography, percutaneous intervention or device insertion at Gosford Hospital, John Hunter Hospital, Coff’s Harbour Hospital, Port Macquarie Base Hospital, Tamworth Hospital and Dubbo Base Hospital who consent to become enrolled in the trial. The main study endpoints include the primary outcome of self-reported anxiety levels, as measured by the STAIS-5 (Short-Form State-Trait Anxiety Inventory). Secondary outcomes include patient reported pain, adverse outcomes (MACE: Major Adverse Cardiac Events), dosages of sedative medications required, radial artery spasm, haemodynamic data, operator anxiety, complications.
Interventions
The objective of this study is to determine whether and how the use of music in the cardiac catheter laboratory influences the patient experience. The study population consists of participants undergoing best practice coronary angiography, percutaneous intervention or device insertion at participating hospitals in NSW.
The intervention will be whether music or no music is played during their procedure. The primary outcome will be self- reported anxiety scores (as measured by STAIS-5 questionnai
The objective of this study is to determine whether and how the use of music in the cardiac catheter laboratory influences the patient experience. The study population consists of participants undergoing best practice coronary angiography, percutaneous intervention or device insertion at participating hospitals in NSW. The intervention will be whether music or no music is played during their procedure. The primary outcome will be self- reported anxiety scores (as measured by STAIS-5 questionnaire). The genre of music will be chosen by the patient from a selection of pre- made Spotify playlists (6 genres, Aussie classics, soft rock, dance/ house, classical/jazz, pop, Indie).
Sponsors
Central Coast Local Health District
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
· Age greater than or equal to 18 years. · Undergoing planned best practice coronary angiography or device insertion at Gosford Hospital, John Hunter Hospital, Port Macquarie Base Hospital, Coff’s Harbour Hospital, Tamworth Hospital and Dubbo Base Hospital. · Provide written informed consent before study participation
Exclusion criteria
· Inability to consent to trial participation. · Requiring emergency procedures with insufficient time to consent and go through the patient reported outcome measures. · Enrolment in an alternate study that competes or interferes with this study. · Any other condition which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
Outcome results
None listed