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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
Date results information 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
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Scientific title
The Effect of Binaural Beat Audio on Operative Pain and Anxiety in Cataract Surgery Under Topical Anaesthesia: A Randomised Controlled Trial
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Secondary ID [1]
302597
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
pain
319479
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anxiety
319480
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Cataracts
321894
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Condition category
Condition code
Mental Health
317444
317444
0
0
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Anxiety
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Eye
317445
317445
0
0
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Diseases / disorders of the eye
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Anaesthesiology
319622
319622
0
0
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Pain management
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
318880
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Treatment: Other
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Comparator / control treatment
Control group: Earphones with no audio
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Control group
Active
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Outcomes
Primary outcome [1]
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Mean difference in pain scores between intervention and control group, as assessed by visual analogue score
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Assessment method [1]
325488
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Timepoint [1]
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Baseline, immediately post surgery
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Primary outcome [2]
325489
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Mean difference in anxiety scores between intervention and control group as assessed by 6-item State-Trait Anxiety Inventory
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Assessment method [2]
325489
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Timepoint [2]
325489
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Baseline, immediately post surgery
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Secondary outcome [1]
388123
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Mean difference in heart rate between intervention and control group using a pulse oximeter.
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Assessment method [1]
388123
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Timepoint [1]
388123
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Baseline, immediately post surgery
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Secondary outcome [2]
388124
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Mean difference in blood pressure between intervention and control group using a sphygmomanometer
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Assessment method [2]
388124
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Timepoint [2]
388124
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Baseline, immediately post surgery
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Eligibility
Key inclusion criteria
Subjects with senile cataract undergoing phacoemulsification with intraocular lens implantation under topical anaesthesia
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment was performed via sealed opaque envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using the random sampling envelope technique
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
3/04/2017
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Date of last participant enrolment
Anticipated
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Actual
28/03/2018
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Date of last data collection
Anticipated
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Actual
28/03/2018
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Sample size
Target
62
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Accrual to date
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Final
61
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Recruitment outside Australia
Country [1]
23072
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Malaysia
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State/province [1]
23072
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Kelantan
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Funding & Sponsors
Funding source category [1]
307023
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University
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Name [1]
307023
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Universiti Sains Malaysia
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Address [1]
307023
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Health Campus Universiti Sains Malaysia
16150 Kubang Kerian, Kelantan, Malaysia
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Country [1]
307023
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Malaysia
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Primary sponsor type
Individual
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Name
Dr Ling Jiunn Loong
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Address
School of Medical Sciences, Health Campus Universiti Sains Malaysia
16150 Kubang Kerian, Kelantan, Malaysia
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Country
Malaysia
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Secondary sponsor category [1]
307601
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Individual
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Name [1]
307601
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Dr Evelyn Tai Li Min
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Address [1]
307601
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School of Medical Sciences, Health Campus Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
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Country [1]
307601
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Malaysia
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Secondary sponsor category [2]
307602
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Individual
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Name [2]
307602
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Dr Kueh Yee Cheng
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Address [2]
307602
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School of Medical Sciences, Health Campus Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
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Country [2]
307602
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Malaysia
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Other collaborator category [1]
281518
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University
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Name [1]
281518
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Universiti Sains Malaysia
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Address [1]
281518
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School of Medical Sciences, Health Campus Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
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Country [1]
281518
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Malaysia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
307155
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Human Research Ethics Committee of Universiti Sains Malaysia
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Ethics committee address [1]
307155
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School of Medical Sciences, Health Campus Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
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Ethics committee country [1]
307155
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Malaysia
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Date submitted for ethics approval [1]
307155
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23/01/2017
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Approval date [1]
307155
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30/03/2017
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Ethics approval number [1]
307155
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USM/JEPeM/16090291
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Summary
Brief summary
Binaural beat audio may decrease operative pain and anxiety in cataract surgery under numbing eyedrops. This study aims to evaluate the effects of binaural beat audio on pain and anxiety in patients undergoing cataract surgery under topical anaesthesia. The primary outcome is the difference in pain score and anxiety scores between the binaural beat audio and the control group. The secondary outcomes are the differences in heart rate and blood pressure between the binaural beat audio and the control group, as well as the mean changes in anxiety scores, heart rate and blood pressure within each group (intervention and control) over time.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Ling Jiun Loong
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Address
106222
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Health Campus Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
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Country
106222
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Malaysia
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Phone
106222
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+60179008881
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Fax
106222
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Email
106222
0
[email protected]
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Contact person for public queries
Name
106223
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Dr Evelyn Tai Li Min
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Address
106223
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Health Campus Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
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Country
106223
0
Malaysia
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Phone
106223
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+60122916193
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Fax
106223
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Email
106223
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[email protected]
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Contact person for scientific queries
Name
106224
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Dr Evelyn Tai Li Min
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Address
106224
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Health Campus Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
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Country
106224
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Malaysia
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Phone
106224
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+60122916193
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Fax
106224
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Email
106224
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
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When will data be available (start and end dates)?
Beginning 3 months and ending 1 year following main results publication
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Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
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Available for what types of analyses?
To achieve the aims in the approved proposal
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How or where can data be obtained?
Access subject to approvals by Primary Sponsor (
[email protected]
)
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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.
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