Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000817741
Ethics application status
Approved
Date submitted
14/04/2022
Date registered
9/06/2022
Date last updated
24/08/2023
Date data sharing statement initially provided
9/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomized Clinical Trial to Compare the Effects of Music and Informative Videos on Patient Anxiety During Endodontic Treatment
Scientific title
A Randomized Clinical Trial to Compare the Effects of Music and Informative Videos on Patient Anxiety During Endodontic Treatment
Secondary ID [1] 306894 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental anxiety 326011 0
Condition category
Condition code
Oral and Gastrointestinal 323316 323316 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 323503 323503 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Group1=Music intervention
(The patient will be asked to wear headphones and listen to music for about 2 hours while performing root canal treatment).
2. Group2= Informative video intervention
(The patient will be asked to watch an informative video related to the procedure before starting the 2 hours treatment for 5 minutes).

*the clinical study will be done in 1 appointment, so the readings will be recorded in 1 visit.
*The post graduate student/ dentist will be responsible about administering the intervention.
*Adherence to the intervention will be monitored in an Dental record.
Intervention code [1] 323355 0
Treatment: Other
Comparator / control treatment
Control group = Without distraction method
( patient will not watch a video or listen to music , only vital signs will be recorded )
Control group
Active

Outcomes
Primary outcome [1] 331505 0
Change in anxiety level as assessed by Blood pressure which will be measured by electronic sphygmomanometer,
Timepoint [1] 331505 0
The vital sign (systolic blood pressure, diastolic blood pressure) will be recorded 4 times; first before starting the procedure (baseline) then at the midpoint during the procedure (one recording after local anesthesia delivery and other recording after pulp extirpation/GP retrieval) and the final recording at the end of treatment (primary endpoint
Primary outcome [2] 331506 0
Change in anxiety level as assessed by pulse rate measured by electronic sphygmomanomete (it measures diastolic, systolic blood pressure and pulse rate)
Timepoint [2] 331506 0
The vital sign ( pulse rate) will be recorded 4 times; first before starting the procedure (baseline) then at the midpoint during the procedure (one recording after local anesthesia delivery and other recording after pulp extirpation/GP retrieval) and the final recording at the end of treatment
Primary outcome [3] 331507 0
Change in anxiety level as assessed by oxygen saturation measured by pulse oximeter
Timepoint [3] 331507 0
The vital sign (oxygen saturation level) will be recorded 4 times; first before starting the procedure (baseline) then at the midpoint during the procedure (one recording after local anesthesia delivery and other recording after pulp extirpation/GP retrieval) and the final recording at the end of treatment
Secondary outcome [1] 408606 0
change in pain score/level using visual analog scale for pain (VAS-pain)
Timepoint [1] 408606 0
Two-time points (pre and post treatment) Change in pain level assessed using visual analog scale for pain (VAS-pain)
Secondary outcome [2] 413630 0
corah's dental anxiety scale
Timepoint [2] 413630 0
before starting the procedure

Eligibility
Key inclusion criteria
1- Patients between the age of 18-65 years
2- Both genders will be included
3- Primary root canal treatment and retreatment
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Surgical endodontics
2- Vital pulp therapy
3- Patients with the history of hypertension or cardiovascular diseases

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software ( Microsoft Excel)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2022
Actual
15/09/2022
Date of last participant enrolment
Anticipated
15/09/2023
Actual
10/05/2023
Date of last data collection
Anticipated
15/09/2023
Actual
10/05/2023
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 24725 0
United Arab Emirates
State/province [1] 24725 0

Funding & Sponsors
Funding source category [1] 311208 0
University
Name [1] 311208 0
university of Sharjah
Country [1] 311208 0
United Arab Emirates
Primary sponsor type
University
Name
university of sharjah
Address
College of Dental Medicine, University of Sharjah, University city, Sharjah, PO Box: 27272, United Arab Emirates.
Country
United Arab Emirates
Secondary sponsor category [1] 312586 0
None
Name [1] 312586 0
Address [1] 312586 0
Country [1] 312586 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310737 0
research and graduate studies research ethics committee at university of Sharjah
Ethics committee address [1] 310737 0
Ethics committee country [1] 310737 0
United Arab Emirates
Date submitted for ethics approval [1] 310737 0
02/04/2022
Approval date [1] 310737 0
02/04/2022
Ethics approval number [1] 310737 0
REC-22-04-02-01-S

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

Contacts
Principal investigator
Name 118690 0
Dr Sarah Ali Abdulhameed
Address 118690 0
College of Dental Medicine, University of Sharjah, University city, Sharjah, PO Box: 27272, United Arab Emirates.
Country 118690 0
United Arab Emirates
Phone 118690 0
+971508757083
Fax 118690 0
Email 118690 0
[email protected]
Contact person for public queries
Name 118691 0
Sarah Ali Abdulhameed
Address 118691 0
College of Dental Medicine, University of Sharjah, University city, Sharjah, PO Box: 27272, United Arab Emirates.
Country 118691 0
United Arab Emirates
Phone 118691 0
+971508757083
Fax 118691 0
Email 118691 0
[email protected]
Contact person for scientific queries
Name 118692 0
Sarah Ali Abdulhameed
Address 118692 0
College of Dental Medicine, University of Sharjah, University city, Sharjah, PO Box: 27272, United Arab Emirates.
Country 118692 0
United Arab Emirates
Phone 118692 0
+971508757083
Fax 118692 0
Email 118692 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15803Ethical approval  [email protected] 383908-(Uploaded-13-04-2022-19-09-14)-Study-related document.pdf
15804Informed consent form    383908-(Uploaded-14-04-2022-02-59-33)-Study-related document.pdf



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.