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
Date results information initially provided
24/08/2023
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
Office of Vice Chancellor for Research & Graduate Study Research and Ethics Committee, University of Sharjah, University city, Sharjah, PO Box: 27272, United Arab Emirates.
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
.The current study aims to test the effectiveness of music intervention and informative video as distraction tools during endodontic treatment. Another feature of our study that makes it unique is that we are comparing two different distraction methods to see which one has a better effect on reducing patient’s anxiety level during endodontic treatment.

Null hypothesis:
Our null hypothesis states that there is no significant difference in anxiety level during endodontic treatment when using music or informative video as distraction tools

Alternative hypothesis:
Our alternative hypothesis states that there is a significant difference in anxiety level during endodontic treatment when using music or informative video as distraction tools

Significance of the study:
Significance of this study is to evaluate the efficacy of music intervention and informative video as distraction methods on reducing anxiety during endodontic treatment which will help the patients to overcome their fears toward endodontic treatment
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
U21100357@sharjah.ac.ae
Contact person for public queries
Name 118691 0
Dr 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
U21100357@sharjah.ac.ae
Contact person for scientific queries
Name 118692 0
Dr 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
U21100357@sharjah.ac.ae

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  U21100357@sharjah.ac.ae 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.