- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02535143
Impact of Energy Drinks on the Manual Dexterity of Final Year Dental Students
The Impact of Energy Drinks on the Manual Dexterity of Final Year Dental Students
This study aims to test the hypothesis that there was a relationship between the consumption of energy drinks and the manual dexterity skills of final year dental students.
Identification of baseline caffeine consumption and selection of sample Baseline caffeine consumption will be identified by distributing the caffeine consumption questionnaire to all the final year students of the Riyadh Colleges of Dentistry and Pharmacy. The study will recruit 60 students who are moderate caffeine consumers. To avoid the confounding effect of nicotine consumption, the study will only recruit non-smokers .female candidates taken oral contraceptives and Subjects with any history of renal disease will be excluded.
All subjects will be required to prepare a box 2mmx2mmx2mm using a high speed handpiece (NSK, Japan) and a no.330 cutting bur. Each participant will be allowed two attempts to cut the cavity in each test both cavities will be selected for assessment. The ability of the participants to reproduce the dimensions (2mmx2mmx2mm) and the time taken to complete the task will be used as criteria to evaluate dexterity. The participants will be required to perform the test before and 30 minutes after energy drink exposure.
Energy Drink Exposure Subjects will be given 330ml of an energy three hours after the last meal in the other hand the control group will be receiving a placebo drink .
Dexterity outcomes will be compared before and after exposure to the energy drink using the paired t test. Outcomes will be compared between different groups and different time intervals using the two way, multiple measures ANOVA. All data will be analyzed using the SPSS ver.21 data processing software.
Study Overview
Status
Conditions
Detailed Description
The dentistry training program has been reported to be a stressful one; and while academic pressures are high, the high level of dexterity skills that dentistry demands are often cited as a major source of stress. There is some research on the impact that caffeine in general and energy drinks in particular can have on academic performance, however, there is considerably less data on the impact of these drinks on manual dexterity. This study aims to test the hypothesis that there was a relationship between the consumption of energy drinks and the manual dexterity skills of final year dental students.
Identification of baseline caffeine consumption and selection of sample Baseline caffeine consumption will be identified by distributing the caffeine consumption questionnaire to all the final year students of the Riyadh Colleges of Dentistry and Pharmacy. Based on the caffeine consumption score the study will recruit 60 moderate. To avoid the confounding effect of nicotine consumption, the study will only recruit non-smokers .female candidates taken oral contraceptives will be eliminated due to the correlation between them and caffeine. Subjects with any history of renal disease will be prevented from participation in the study Test for manual dexterity Acrylic blocks (2cmx2cmx2cm) will be prepared using a standardized mold. All subjects will be required to prepare a box 2mmx2mmx2mm using a high speed handpiece (NSK, Japan) and a no.330 cutting bur. Each participant will be allowed two attempts to cut the cavity in each test both cavities will be selected for assessment. The ability of the participants to reproduce the dimensions (2mmx2mmx2mm) and the time taken to complete the task will be used as criteria to evaluate dexterity. The participants will be required to perform the test before and 30 minutes after energy drink exposure.
Energy Drink Exposure Subjects in the test group (n 30) will be given 330ml of an energy drink containing caffeine, sugar and taurine (Red Bull, Red Bull GmbH, Austria Vienna) three hours after the last meal in the other hand the control group (n30) will be receiving a placebo drink which is apple juice.
Statistical Analysis Dexterity outcomes will be compared before and after exposure to the energy drink using the paired t test. Outcomes will be compared between different groups and different time intervals using the two way, multiple measures ANOVA. All data will be analyzed using the SPSS ver.21 data processing software.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Riyadh, Saudi Arabia
- Riyadh Colleges of Dentistry and Pharmacy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Final year dental student
- Able to prepare acceptable test cavity (2mmx2mmx2mm) prior to intervention
Exclusion Criteria:
- Smokers
- Women on Oral Contraceptives
- History of Renal Disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Group
Group will prepare a test cavity in an acrylic block.
They will receive 250 ml of a commercially available energy drink containing caffeine and taurine (Red Bull, Red Bull GmBh Austria) three hours after the last meal.
The participants will then be required to perform a post intervention test cavity preparation 30 minutes after consuming the drink.
|
Subjects will be asked to prepare a cavity 2mmx 2mmx 2mm in an acrylic block using an airotor and a tungsten carbide bur prior to consuming the test drink
Other Names:
250 ml of commercially available taurine containing energy drink to be administered three hours after the last meal and half an hour prior to performing the second test cavity
Other Names:
Subjects will be asked to prepare a cavity 2mmx 2mmx 2mm in an acrylic block 30 minutes after consuming the intervention drink using an airotor and a tungsten carbide bur prior to consuming the test drink
|
Placebo Comparator: Control Group
Group will prepare a test cavity in an acrylic block.
They will receive 250ml of a commercially available carbonated apple juice (Appy Fizz, Parle Agro, Mumbai, India) three hours after the last meal.
The participants will then be required to perform a post intervention test cavity preparation 30 minutes after consuming the drink.
|
Subjects will be asked to prepare a cavity 2mmx 2mmx 2mm in an acrylic block using an airotor and a tungsten carbide bur prior to consuming the test drink
Other Names:
Subjects will be asked to prepare a cavity 2mmx 2mmx 2mm in an acrylic block 30 minutes after consuming the intervention drink using an airotor and a tungsten carbide bur prior to consuming the test drink
250ml of commercially available carbonated apple juice to be administered three hours after the last meal and half an hour prior to performing the second test cavity
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cavity Accuracy in mm
Time Frame: Immediate
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Accuracy of the test cavity prepared in mm
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Immediate
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time taken to prepare the cavity in seconds
Time Frame: immediate
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Time taken in seconds to prepare the test cavity
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immediate
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Collaborators and Investigators
Publications and helpful links
General Publications
- Almalak H, Albluwi AI, Alkhelb DA, Alsaleh HM, Khan TM, Hassali MA, Aljadhey H. Students' attitude toward use of over the counter medicines during exams in Saudi Arabia. Saudi Pharm J. 2014 Apr;22(2):107-12. doi: 10.1016/j.jsps.2013.02.004. Epub 2013 Mar 21.
- Alsunni AA, Badar A. Energy drinks consumption pattern, perceived benefits and associated adverse effects amongst students of University of Dammam, Saudi Arabia. J Ayub Med Coll Abbottabad. 2011 Jul-Sep;23(3):3-9.
- Arai YC, Kandatsu N, Ito H, Sato Y, Satake Y, Mizutani M, Ushida T, Komatsu T. Induction and emergence behavior of children undergoing general anesthesia correlates with maternal salivary amylase activity before the anesthesia. Acta Anaesthesiol Scand. 2008 Feb;52(2):285-8. doi: 10.1111/j.1399-6576.2007.01527.x. Epub 2007 Nov 14.
- Arria AM, Bugbee BA, Caldeira KM, Vincent KB. Evidence and knowledge gaps for the association between energy drink use and high-risk behaviors among adolescents and young adults. Nutr Rev. 2014 Oct;72 Suppl 1(0 1):87-97. doi: 10.1111/nure.12129.
- Azagba S, Langille D, Asbridge M. An emerging adolescent health risk: caffeinated energy drink consumption patterns among high school students. Prev Med. 2014 May;62:54-9. doi: 10.1016/j.ypmed.2014.01.019. Epub 2014 Feb 4.
- GOLDBERG AA, JEFFERIES HS. Potentiation of insulin hypoglycaemia by nicotinyl taurine (beta-nicotinamidoethanesulphonic acid). Q J Pharm Pharmacol. 1946 Jan-Mar;19:48-53. No abstract available.
- Pai KM, Kamath A, Goel V. Effect of Red Bull energy drink on muscle performance: an electromyographic overview. J Sports Med Phys Fitness. 2015 Dec;55(12):1459-65. Epub 2014 Oct 21.
- Spierer DK, Blanding N, Santella A. Energy drink consumption and associated health behaviors among university students in an urban setting. J Community Health. 2014 Feb;39(1):132-8. doi: 10.1007/s10900-013-9749-y.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FUGRP/2014/183.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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