None listed
Conditions
Brief summary
Patients recovering from cardiac surgery often experience significant pain, anxiety and distress in the first few days after their operation. Previous studies suggest that playing relaxing music and positive therapeutic suggestions to patients while they are under general anaesthesia may help improve recovery after surgery. This pilot study will investigate whether delivering relaxing music and recorded therapeutic suggestions through noise-cancelling headphones during cardiac surgery is feasible and acceptable for patients and clinical staff. Participants undergoing cardiac surgery will be randomly assigned to receive either standard care or standard care plus the headphone intervention, which will begin after induction of anaesthesia and continue until the breathing tube is removed in the intensive care unit. The main aim of this pilot study is to determine whether the intervention can be successfully delivered and whether patients can be recruited and followed up reliably. Information from this pilot study will be used to plan a larger clinical trial to test whether this intervention improves recovery after cardiac surgery, including pain, quality of recovery, and other postoperative outcomes.
Interventions
Participants will be randomised to either standard perioperative care or standard care plus the study intervention.
The intervention consists of the application of active noise-cancelling over-ear headphones after induction of general anaesthesia for adult cardiac surgery. The headphones will deliver an audio program comprising relaxing music and recorded therapeutic suggestions. The audio program will play continuously during surgery and remain in place postoperatively in the intensive care un
Participants will be randomised to either standard perioperative care or standard care plus the study intervention. The intervention consists of the application of active noise-cancelling over-ear headphones after induction of general anaesthesia for adult cardiac surgery. The headphones will deliver an audio program comprising relaxing music and recorded therapeutic suggestions. The audio program will play continuously during surgery and remain in place postoperatively in the intensive care unit until tracheal extubation. Monitoring adherence to the intervention will occur by direct observation by the clinician caring for the patient (e.g. the anaesthetist during the operation, the ICU nurse during the ICU admission) and sporadic checks by study investigators. The therapeutic suggestions are delivered via a pre-recorded script developed by an anaesthetist with training in hypnosis and adapted from previously published perioperative suggestion protocols. The audio program includes relaxing music created with input from music therapists and alternates between music, therapeutic suggestions, and brief silent intervals. The intervention is anticipated to last 6-12 hours (depending on how soon the patient is extubated after surgery). An example of therapeutic suggestions include: "The highest priority is your safety and well-being is and the anaesthetist and the health care professionals are there to ensure your safety and well-being. They will be by your side at any point in time until you fully recovered from the surgery. They will provide the best care for you." Participants in the control group will receive standard perioperative anaesthesia and analgesia without headphones or audio intervention. Reference: BMJ 2020;371:m4284 Example of therapeutic suggestions Appendix 10.1
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or older, scheduled for elective or urgent (non-emergency) cardiac surgery performed via median sternotomy (e.g., coronary artery bypass graft (CABG), valve surgery, combined procedures). Planned postoperative management in the intensive care unit (ICU) with mechanical ventilation and extubation expected in ICU (to allow delivery of the intervention from induction until extubation). Able to understand study information and provide written informed consent.
Exclusion criteria
Age less than 18 years. Cardiac surgery performed without a median sternotomy incision (e.g. minimally invasive or thoracotomy approaches). Planned rapid-extubation or fast-track cardiac anaesthesia pathway. Emergency cardiac surgery. Known hearing impairment preventing perception of the audio intervention Unable to provide informed consent.
Outcome results
None listed