Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001095358p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
24/07/2026
Date registered
Help: Date registered
4/09/2026
Date last updated
Help: Date last updated
4/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
4/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing stress during cataract surgery: A study of AI-generated ambient music and binaural beats in adults receiving a sub-tenon eye anaesthetic block
Scientific title
The effects of AI-generated ambient music and binaural beats on perioperative stress in adults undergoing elective cataract surgery with a sub-tenon anaesthetic block without sedation: A randomised controlled trial
Additional trial identifiers [1] 318296 0
Nill
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Perioperative stress in patients undergoing cataract surgery 342998 0
Cataract 342999 0
Preoperative stress 343000 0
Condition category
Condition code
Eye 339097 339097 0 0
Diseases / disorders of the eye
Mental Health 339098 339098 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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.
Intervention code [1] 334877 0
Treatment: Other
Intervention code [2] 335113 0
Treatment: Devices
Description of the comparator or control
Participants allocated to the comparator group will receive identical non-noise-cancelling headphones worn for the same duration as the intervention groups, commencing 30 minutes before transfer to the operating theatre and continuing during administration of the sub-tenon anaesthetic block until immediately prior to surgery. No audio, ambient music, binaural beats, or other auditory content will be delivered through the headphones. Participants will therefore be exposed only to the usual sounds of the preoperative and operating theatre environments consistent with standard care. Headphone use and duration of wear will be monitored and documented by the research team.
Control group
Placebo

Outcomes
Primary outcome [1] 346338 0
Primary Outcome 1: Physiological stress,
Timepoint [1] 346338 0
Physiological stress will be assessed using Bispectral Index (BIS) scores and haemodynamic parameters (heart rate and blood pressure). Measurements will be recorded at baseline prior to intervention commencement and every 2 minutes during administration of the sub-tenon anaesthetic block until immediately before surgery.
Primary outcome [2] 346695 0
Primary Outcome 2: Psychological stress,
Timepoint [2] 346695 0
Psychological stress will be assessed using the Brief Measure of Emotional Preoperative Stress (B-MEPS) questionnaire. The B-MEPS will be administered at baseline prior to intervention commencement and immediately before transfer to the operating theatre.
Secondary outcome [1] 465466 0
Requirement for perioperative pharmacological interventions, including anxiolytic and analgesic medications.
Timepoint [1] 465466 0
From commencement of the intervention until discharge following the surgical procedure.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be achieved using a computer-generated randomisation sequence prepared by an independent person not involved in participant recruitment or outcome assessment. Group allocation will be concealed until the participant has been enrolled and assigned to a study group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation sequence will be used to allocate participants to one of three study groups: AI-generated ambient music, AI-generated binaural beats, or control. Randomisation will be conducted using a computer-based random number generation process.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated to detect a clinically meaningful difference in Bispectral Index (BIS) scores between the AI-generated ambient music, AI-generated binaural beats, and control groups. Based on previous literature, a 5–10 unit difference in BIS scores with a common standard deviation of 10 was considered clinically relevant. A total sample size of 81 participants (27 per group) was estimated to provide 90% power at a two-sided alpha level of 0.05. To allow for potential attrition and protocol deviations, the sample size was increased by 10%, resulting in a final recruitment target of 90 participants (30 per group).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2027
Actual
Date of last participant enrolment
Anticipated
15/07/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 29912 0
Darwin Private Hospital - Tiwi
Recruitment postcode(s) [1] 46269 0
0810 - Tiwi

Funding & Sponsors
Funding source category [1] 322552 0
University
Name [1] 322552 0
Charles Darwin University (CDU) Research Support Funding and Faculty of Health.
Country [1] 322552 0
Australia
Primary sponsor type
University
Name
Charles Darwin University
Address
Country
Australia
Secondary sponsor category [1] 325472 0
None
Name [1] 325472 0
Address [1] 325472 0
Country [1] 325472 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 321029 0
Charles Darwin University Human Research Ethics Committee
Ethics committee address [1] 321029 0
Ethics committee country [1] 321029 0
Australia
Date submitted for ethics approval [1] 321029 0
17/09/2026
Approval date [1] 321029 0
Ethics approval number [1] 321029 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152426 0
Mrs Maria Dorothea Rothmann
Address 152426 0
Charles Darwin University Ellengowan Drive Casuarina NT 0810 Australia
Country 152426 0
Australia
Phone 152426 0
+61 451328050
Fax 152426 0
Email 152426 0
[email protected]
Contact person for public queries
Name 152427 0
Maria Dorothea Rothmann
Address 152427 0
Charles Darwin University Ellengowan Drive Casuarina NT 0810 Australia
Country 152427 0
Australia
Phone 152427 0
+61 451328050
Fax 152427 0
Email 152427 0
[email protected]
Contact person for scientific queries
Name 152428 0
Maria Dorothea Rothmann
Address 152428 0
Charles Darwin University Ellengowan Drive Casuarina NT 0810 Australia
Country 152428 0
Australia
Phone 152428 0
+61 451328050
Fax 152428 0
Email 152428 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.