None listed
Conditions
Brief summary
This study aims to find out whether listening to artificial intelligence (AI)-generated ambient music or AI)-generated binaural beats can reduce stress in adults undergoing cataract surgery while awake under a sub-tenon eye anaesthetic block. The researchers expect that participants who listen to AI-generated ambient music or binaural beats will experience lower levels of stress than participants who do not receive an audio intervention. The study also aims to determine whether these interventions can improve recovery, reduce the need for anxiety-relieving or pain-relieving medications, and shorten the amount of time spent in hospital after the procedure. Participants will be randomly assigned to one of three groups: AI-generated ambient music, AI-generated binaural beats, or a comparison group that wears headphones without any audio. Stress will be measured using brain activity monitoring, blood pressure, heart rate, breathing rate, and questionnaires completed before and after surgery. Hospital stay and medication use will also be reviewed from clinical records. The results of this study may help identify safe, low-cost, non-drug approaches to reducing stress and improving the surgical experience for people undergoing cataract surgery.
Interventions
Participants will be randomly allocated to one of three groups: (1) AI-generated ambient music delivered through non-noise-cancelling headphones, (2) AI-generated binaural beats delivered through non-noise-cancelling headphones, or (3) a control group receiving identical non-noise-cancelling headphones with no audio input. The allocated intervention will commence 30 minutes before transfer to the operating theatre and continue during administration of the sub-tenon anaesthetic block until immedi
Participants will be randomly allocated to one of three groups: (1) AI-generated ambient music delivered through non-noise-cancelling headphones, (2) AI-generated binaural beats delivered through non-noise-cancelling headphones, or (3) a control group receiving identical non-noise-cancelling headphones with no audio input. The allocated intervention will commence 30 minutes before transfer to the operating theatre and continue during administration of the sub-tenon anaesthetic block until immediately prior to surgery. Participants in the ambient music group will listen to the same standardised AI-generated instrumental relaxation track, incorporating gentle ambient and nature-inspired sounds tuned to a 432 Hz standard. Participants in the binaural beat group will receive the same standardised AI-generated binaural beat recording embedded within an ambient soundscape, using a 432 Hz carrier frequency and an alpha-range binaural beat frequency of 8 to 12 Hz. Audio volume for both interventions will be standardised at a moderate listening level (approximately 50 to 60 dB(A)) and may be adjusted within a safe range (45 to 65 dB(A)) to ensure participant comfort. Adherence will be monitored through direct observation of headphone use and audio playback, documentation of intervention duration, and recording of any interruptions, technical issues, headphone removal, or premature discontinuation. All participants will undergo elective cataract surgery with a sub-tenon anaesthetic block without sedation. The intervention aims to modulate perioperative stress and will be evaluated using Bispectral Index (BIS) scores, haemodynamic parameters, the Brief Measure of Emotional Preoperative Stress (B-MEPS), and the Quality of Recovery-15 (QoR-15) questionnaire.
Sponsors
Charles Darwin University
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
Adult patients aged 18 years and older who are scheduled for elective cataract surgery under a sub-tenon anaesthetic block without systemic sedation, are able to provide written informed consent, demonstrate an adequate understanding of the study requirements, and are willing to participate.
Exclusion criteria
Patients who do not wish to participate; patients undergoing emergency or traumatic cataract procedures; patients with cognitive impairment affecting cooperation, understanding of the study, or ability to provide informed consent; patients with hearing impairment affecting their ability to receive the auditory intervention; patients with a language barrier preventing effective communication or informed consent where an interpreter is not available; patients receiving any form of sedation or general anaesthesia; and patients requiring conversion to general anaesthesia during the procedure.
Outcome results
None listed