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.: PACTR201904716891248 Date of Approval: 18/04/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of Conventional and Audiovisual Information on Anxiety and Postoperative Morbidity Following Third Molar Surgery: A Randomised Study.
Official scientific title Comparison of Conventional and Audiovisual Information on Anxiety and Postoperative Morbidity Following Third Molar Surgery: A Randomised Study.
Brief summary describing the background and objectives of the trial Surgical extraction of impacted mandibular third molar (M3) is one of the commonest surgeries performed by the Oral and Maxillofacial surgeon. These surgeries are associated with post-operative inflammatory sequelae such as pain, swelling and trismus. These complications are a source of discomfort to patients and have been reported to cause a deterioration of quality of life in the immediate post-operative period and may account for days off work. The literature is replete with different studies on surgical and pharmacologic parameters that may ameliorate these postoperative discomforts. Little is however known about the social and psychological impact on the outcomes of oral surgical procedures. Research has reported that high levels of state and trait anxiety are associated with poorer postoperative recovery and the risks for complications. Information has also been shown to have impact on dental anxiety and may have impact on the post-operative complications. This information can be provided using multiple formats such as oral, written, audiovisual or combinations of two or more of these formats The objectives of the study will be: i. To determine the effect of conventional information on anxiety and postoperative outcomes. ii. To determine the effect of audiovisual information on anxiety and postoperative outcomes. iii. To compare the effects of conventional and audiovisual information on anxiety and postoperative outcomes iv. To determine the effect of intraoperative factors on postoperative outcomes v. To determine the interactions between the pre-operative and intra-operative factors and their impact on post-operative outcomes. vi. To identify the sources of anxiety in patients undergoing third molar surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 25/03/2019
Actual trial start date
Anticipated date of last follow up 28/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group verbal information 7days participant will receive verbal information only before extraction of the impacted third molar 45 Active-Treatment of Control Group
Experimental Group verbal and audiovisual information 7day participants will receive both verbal and audiovisual information before the extraction of the impacted third molar 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Participants aged between 18 years and 35 years. 2. Participants who have never had a tooth extraction. 3. Participants with impacted mandibular third molar confirmed by periapical radiograph and indicated for surgical extraction. 4. Participants who can understand and comprehend both written and verbal information about third molar extraction procedure. 5. Participants with complete maxillary and mandibular incisors to enable measurement of maximal inter-incisal distance 6. Participants who give consent to take part in the study. 1. Participants with uncontrolled medical or systemic disease contraindicating surgical extraction under local anesthesia e.g. compromised cardiac function, hematological abnormalities, metabolic disorders, central nervous system disorder, impaired renal or hepatic function or depressed respiratory functions 2. Participants with chronic health conditions that affect blood pressure, pulse rate and heart rate such as sleep disorders. 3. Participants taking anxiolytic medications or receiving anxiety reduction therapy. 4. Participants with stress and anxiety disorders such as post-traumatic stress disorders assessed using trauma screening questionnaire. 5. Participants with peptic ulcer disease. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 35 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 07/09/2018 Ethics and Research Committee OAUTHC
Ethics Committee Address
Street address City Postal code Country
Ilesa road Ile-Ife Ile-ife 230001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Swelling Trismus preoperatively, post operative day 1, day 3 and day 7
Secondary Outcome STAI-S MDAS preoperatively, post operative day 1, day 3 and day 7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospital Complex llesa road ile ife 230001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Obafemi Awolowo University Teaching Hospital Complex Ilesa road Ile Ife 230001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Obafemi Awolowo University Teaching Hospital Complex Ilesa road Ile Ife 230001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof. O.A Fatusi OAU Staff Quaters Ile Ife 230001 Nigeria
Prof. M.O Ukpong OAU Staff Quaters Ile Ife 230001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayodele Akomolafe drkomoo80@gmail.com +2347086270621 Eleyele
City Postal code Country Position/Affiliation
Ile Ife 230001 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Ayodele Akomolafe drkomoo80@gmail.com +2347086270621 OAUTHC quaters Eleyele
City Postal code Country Position/Affiliation
Ile Ife 230001 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Ayodele Akomolafe drkomoo80@gmail.com +2347086270621 Eleyele
City Postal code Country Position/Affiliation
Ile Ife 230001 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Each participant in Group A will receive Verbal information only before the third molar surgery while participant in Group B will receive both verbal and audiovisual information . The effects of these varied types of information on anxiety and postoperative morbidity will then be assessed in each participant and compared in both groups. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12months Anxiety , information and impacted third molar surgery
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