Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12621001182886
Ethics application status
Approved
Date submitted
25/10/2020
Date registered
3/09/2021
Date last updated
3/09/2021
Date data sharing statement initially provided
3/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Binaural Beat Audio on Pain and Anxiety in Cataract Surgery under Numbing Eyedrops
Scientific title
The Effect of Binaural Beat Audio on Operative Pain and Anxiety in Cataract Surgery Under Topical Anaesthesia: A Randomised Controlled Trial
Secondary ID [1] 302597 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain 319479 0
anxiety 319480 0
Cataracts 321894 0
Condition category
Condition code
Mental Health 317444 317444 0 0
Anxiety
Eye 317445 317445 0 0
Diseases / disorders of the eye
Anaesthesiology 319622 319622 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Binaural beats (Happiness Frequency 10Hz Binaural Beats, Greenred Production) through earphones positioned by a single researcher in the operating theatre. The researcher would first switch on the MP3 player and test the volume, as well as ensure that the subject was comfortable with it. Patients were exposed to the beats 10 minutes before the start of cataract surgery until immediately after completion of surgery.

Cataract surgery was performed under topical anaesthesia, consisting of proparacaine hydrochloride 0.5% (Alcaine, Alcon, Puurs, Belgium). All patients were also given non-preserved intracameral lidocaine hydrochloride 1% at the commencement of the surgery. No oral or intravenous sedation were used. Phacoemulsification was performed in the standard manner by two ophthalmologists. Surgical duration was approximately 40 minutes.
Intervention code [1] 318880 0
Treatment: Other
Comparator / control treatment
Control group: Earphones with no audio
Control group
Active

Outcomes
Primary outcome [1] 325488 0
Mean difference in pain scores between intervention and control group, as assessed by visual analogue score
Timepoint [1] 325488 0
Baseline, immediately post surgery
Primary outcome [2] 325489 0
Mean difference in anxiety scores between intervention and control group as assessed by 6-item State-Trait Anxiety Inventory
Timepoint [2] 325489 0
Baseline, immediately post surgery
Secondary outcome [1] 388123 0
Mean difference in heart rate between intervention and control group using a pulse oximeter.
Timepoint [1] 388123 0
Baseline, immediately post surgery
Secondary outcome [2] 388124 0
Mean difference in blood pressure between intervention and control group using a sphygmomanometer
Timepoint [2] 388124 0
Baseline, immediately post surgery

Eligibility
Key inclusion criteria
Subjects with senile cataract undergoing phacoemulsification with intraocular lens implantation under topical anaesthesia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous intraocular surgery, pre-existing concomitant ocular disease (e.g. glaucoma), hearing impairment, neurological disease, psychiatric disease, use of anxiolytic medications, and presence of intraoperative complications necessitating conversion to extracapsular cataract extraction.

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 was performed via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using the random sampling envelope technique
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation was conducted using G*Power 3.1.9.7. The parameters used for the sample size calculation were effect size = 0.20, alpha value = 0.05, power = 0.80, number of groups = 2, number of measurement = 2 times. The estimated sample size was 31 per group with total sample size of 62.

Statistical Package for the Social Sciences (SPSS) version 25.0 will be used for data analysis. Independent sample t-test and Pearson chi-square statistic will be used to compare numerical and categorical variables between groups. Paired sample t-test will be used for pre and post test measurements within each group. A p-value of < 0.05 will be taken as a significant result.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/04/2017
Date of last participant enrolment
Anticipated
Actual
28/03/2018
Date of last data collection
Anticipated
Actual
28/03/2018
Sample size
Target
62
Accrual to date
Final
61
Recruitment outside Australia
Country [1] 23072 0
Malaysia
State/province [1] 23072 0
Kelantan

Funding & Sponsors
Funding source category [1] 307023 0
University
Name [1] 307023 0
Universiti Sains Malaysia
Country [1] 307023 0
Malaysia
Primary sponsor type
Individual
Name
Dr Ling Jiunn Loong
Address
School of Medical Sciences, Health Campus Universiti Sains Malaysia
16150 Kubang Kerian, Kelantan, Malaysia
Country
Malaysia
Secondary sponsor category [1] 307601 0
Individual
Name [1] 307601 0
Dr Evelyn Tai Li Min
Address [1] 307601 0
School of Medical Sciences, Health Campus Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
Country [1] 307601 0
Malaysia
Secondary sponsor category [2] 307602 0
Individual
Name [2] 307602 0
Dr Kueh Yee Cheng
Address [2] 307602 0
School of Medical Sciences, Health Campus Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
Country [2] 307602 0
Malaysia
Other collaborator category [1] 281518 0
University
Name [1] 281518 0
Universiti Sains Malaysia
Address [1] 281518 0
School of Medical Sciences, Health Campus Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
Country [1] 281518 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307155 0
Human Research Ethics Committee of Universiti Sains Malaysia
Ethics committee address [1] 307155 0
Ethics committee country [1] 307155 0
Malaysia
Date submitted for ethics approval [1] 307155 0
23/01/2017
Approval date [1] 307155 0
30/03/2017
Ethics approval number [1] 307155 0
USM/JEPeM/16090291

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

Contacts
Principal investigator
Name 106222 0
Dr Ling Jiun Loong
Address 106222 0
Health Campus Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
Country 106222 0
Malaysia
Phone 106222 0
+60179008881
Fax 106222 0
Email 106222 0
[email protected]
Contact person for public queries
Name 106223 0
Evelyn Tai Li Min
Address 106223 0
Health Campus Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
Country 106223 0
Malaysia
Phone 106223 0
+60122916193
Fax 106223 0
Email 106223 0
[email protected]
Contact person for scientific queries
Name 106224 0
Evelyn Tai Li Min
Address 106224 0
Health Campus Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
Country 106224 0
Malaysia
Phone 106224 0
+60122916193
Fax 106224 0
Email 106224 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 1 year following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Primary Sponsor ([email protected])


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.