Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202108664752830 Date of Approval: 24/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of pretreatment information communication on dental anxiety.
Official scientific title Dental Anxiety: Assessing its burden and the effect of pre-treatment information communication among adult dental care seekers in Ibadan, Nigeria.
Brief summary describing the background and objectives of the trial Background: Oral health is an important component of good quality of life. However, assessing or accepting dental treatment may be negatively affected by fear or anxiety. Therefore, it is pertinent to consider anxiety towards dental treatment for effective management, better treatment outcome, and the overall quality of life. Determining the status of the patient prior to treatment will help to plan appropriate treatment towards alleviating the anxiety and also work on the psychology of the patient. This is necessary, as anxiety has been associated with uptake of treatment and may also affect the outcome of the treatment. In order to address the anxiety, communication has been found to be a good way to reduce anxiety among individuals and the modes of communicating information to the patients may either aggravate or alleviate the condition in a dentally anxious individual. Hence, the study sets out to test the effect, two methods of modes of presentation of pretreatment information communication will have in addressing fear among adult dental patients. Aim: To assess the burden of anxiety and the effect of two pre-treatment information communication methods on dental anxiety among adult dental care seekers at UCH in Ibadan, Southwest, Nigeria. Methodology: A randomized control trial. The study is set to compare two methods of pre-treatment information communication, in addressing dental anxiety among adult dental patients and also, compare the objective and subjective methods of assessing Dental Anxiety.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DAPIC
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/03/2022
Actual trial start date 22/09/2022
Anticipated date of last follow up 27/01/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 192
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL No Publication yet
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Audiovisual mode of pretreatment information 10 minutes The patient in the intervention group will have to watch a 10-minute long, self-explanatory video on the treatment (root canal treatment and scaling& polishing) they are about to undergo. The video will be self-developed by the researcher. The participant will view the video before treatment on an iPad, after which they will proceed with the treatment. 96
Control Group Written Information 10 minutes The patient in the control group will read a piece of explanatory written information on the treatment/procedure (root canal treatment and scaling& polishing) they are about to undergo. The participant will have the written document for 10 minutes, after which they will proceed with the treatment. 96 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals aged 18 and above Individuals who have had a record of dental pain Patients for routine scaling and polishing Patients planned for endodontic treatment Patients on medication that causes increase in alpha amylase including aspirin, diuretics, oral contraceptives, corticosteroids, indomethacin, ethyl alcohol. Patients on adrenergic agonist and antagonists e.g anti-hypertensives, anti-asthmatics. Chronic Alcoholics Habitual smokers Patient with Psychiatric disease Patients who have had the prescribed treatment done previously Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/10/2021 UNIVERSITY OF IBADAN UNIVERSITY COLLEGE HOSPITAL ETHICAL COMMITTEE
Ethics Committee Address
Street address City Postal code Country
UI/UCH Health Research Ethics Committee Office, Institute for Advanced Medical Research and Training, College of Medicine, University of Ibadan. Ibadan None Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome This shall be an increase or reduction in dental anxiety. This will be 10 minutes after exposure to intervention/control, then 20 minutes into procedure
Secondary Outcome The effect of invasiveness of the procedure on dental anxiety 20 minutes into the procedure
Secondary Outcome The effectiveness of Salivary alpha amylase biomarker as an objective assessment of dental anxiety 10 minutes after exposure to intervention and control, then 20 minutes into procedure.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dental Center University College Hospital Ibadan Queen Elizabeth Road, Mokola-Yemetu Ibadan. Ibadan Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Consortium for Advanced Research Training in Africa CARTA office, Nairobi Kenya Nairobi 10787 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Consortium for Advanced Research Training in Africa CARTA office, Nairobi Kenya Nairobi 10787 Kenya Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator SHAKEERAH GBADEBO sgbadebo@cartafrica.org +2348064649761 Department of Restorative Dentistry, Faculty of Dentistry, College of Medicine, University of Ibadan.
City Postal code Country Position/Affiliation
Ibadan Nigeria Lecturer in University of Ibadan
Role Name Email Phone Street address
Public Enquiries Shakeerah GBADEBO olaaris2k1@yahoo.com +2348064649761 Department of Restorative Dentistry, Faculty of Dentistry, College of Medicine, University of Ibadan.
City Postal code Country Position/Affiliation
Ibadan Nigeria Lecturer and Researcher in the University of Ibadan.
Role Name Email Phone Street address
Scientific Enquiries Timothy Aladelusi drtimmylee@gmail.com +8033662155 Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, College of Medicine, University of Ibadan.
City Postal code Country Position/Affiliation
Ibadan Nigeria Sub dean Postgraduate Faculty of Dentistry College of Medicine University of Ibadan.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data will be shared with the funding agency (Consortium for Advanced Research Training in Africa (CARTA)) after the disidentification of the participants. Further sharing will be according to CARTA regulations. The information to be shared will include; • Study Protocol • Statistical Analysis Plan • Informed Consent Form • Clinical Study Report • Analytic Code The data will be available to CARTA as soon as data collection is over in July 2022. However, the data may be made available to anyone who wishes to access it for any purpose as CARTA deems fit, following the publication of the summary, with no end date. Informed Consent Form This will be according to the regulation of the funding agency (CARTA) This will be according to the regulation of the funding agency (CARTA)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information