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.: PACTR202009869540675 Date of Approval: 28/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF PARENTAL PRESENCE ON ANXIETY DURING INDUCTION OF ANAESTHESIA IN CHILDREN UNDERGOING ELECTIVE DAY CASE SURGERY
Official scientific title EFFECT OF PARENTAL PRESENCE ON ANXIETY DURING INDUCTION OF ANAESTHESIA IN CHILDREN UNDERGOING ELECTIVE DAY CASE SURGERY
Brief summary describing the background and objectives of the trial The effect of parental presence at induction of anesthesia in the day case theatre in children anxiety and anesthesia has been previously investigated but the few studies to date have produced contradictory results, and little or no study has investigated the issues around parental anxiety (behavior) and the total perceived quality of care. Nowadays, current practice of parental presence during induction of anesthesia has not yet been employed in many centers in our sub region.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TP
Disease(s) or condition(s) being studied Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/10/2020
Actual trial start date 01/10/2020
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Active, not 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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PARENTAL PRESENCE 1 HOUR PARENTS ACCOMPANY A GROUP OF CHILDREN TO THE INDUCTION ROOM 50
Control Group THIS GROUP OF PATIENTS CHILDREN WILL NOT BE ACCOMPANIED BY THEIR PARENTS TO ANAESTHESIA INDUCTION RO NIL ABOUT AN HOUR THE PARENTS OF THESE GROUP OF CHILDREN WILL BE ABSENT DURING SEPARATION AND DURING INDUCTION OF ANAESTHESIA. THE IDEA IS THAT WE WANT TO ESTABLISH IF THE ABSENCE OF PARENTS WILL INFLUENCE THE ANXIETY LEVELS OF THIS GROUP OF CHILDREN 50 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. CHILDREN AGED 2 TO 15 YEARS 2. SURGICAL CONDITION WITH ASA PS I AND II 1. NIL Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 15 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 29/06/2020 OBAFEMI AWOLOWO UNIVERSITY TEACHING HOSPITALS COMPLEX ETHICS AND RESEARCH COMMITTEE
Ethics Committee Address
Street address City Postal code Country
ILESHA ROAD ile-ife 55525 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome EFFECT OF PARENTAL PRESENCE ON CHILDREN ANXIETY DURING ANAESTHESIA INDUCTION AT THE RECEPTION OF THE THEATRE, SEPARATION AND INDUCTION OF ANAESTHESIA
Secondary Outcome COMPARISON OF ANXIETY LEVELS OF PARENTS THAT WILL ACCOMPANY THEIR CHILDREN WITH THOSE PARENTS THAT WILL BE ABSENT DURING INDUCTION RECEPTION OF THE THEATRE, SEPARATION OF CHILDREN AND AT INDUCTION OF ANAESTHESIA
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
OBAFEMI AWOLOWO UNIVERSITY TEACHING HOSPITALS COMPLEX ILESHA ROAD ILEIFE 55525 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ADEMOLA OLUSEGUN TALABI ILESHA ROAD ILEIFE 55525 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ADEMOLA TALABI ademolatalabi1608@gmail.com +2348033469206 ilesha road
City Postal code Country Position/Affiliation
ileife 55525 Nigeria consultant paediatric surgeon
Role Name Email Phone Street address
Scientific Enquiries ADEDAPO SOWANDE drshow286@yahoo.com +2348037153008 ILESHA ROAD
City Postal code Country Position/Affiliation
ILEIFE 55525 Nigeria CONSULTANT SURGEON
Role Name Email Phone Street address
Public Enquiries MUYIWA OWOJUYIGBE muyelo2003@yahoo.com +2348064462319 ILESHA ROAD
City Postal code Country Position/Affiliation
ILEIFE 55525 Nigeria CONSULTANT ANAESTHETISTCHAIRMAN MEDICAL ADVISORY COMMITTEE
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Section A: Individual patient data sharing statement Will individual participant data be available (including data dictionary)? Yes What data will be shared? All of individual participant data collected during the trial , after deidentification What other documents will be available? Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code When will data be available? Immediately following publication, No end date. With who? Anyone who wishes to access the data For what type of analysis? Any purpose By what mechanism will data be made available? Data are available at town hall meeting and on one on one basis (LINK: www.oauthc.com Section B: Results reporting 1. The results summary will be posted within three months of completion of trial 2. The date of first journal publication of results will be made available as soon as possible 3. URL hyperlink(s) related to results and publication 4. Data collected such as demographics will be made available 5. Information to document the progress of number of research participants through each stage of a study in a flow diagram or tabular format will be made available 6. Adverse events occurring to participant will be provided 7. Outcome measures: a table of data for each primary or secondary outcome measure and other relevant statistical analysis performed will be released and made available 8. The results and outcome measures will be summarized and provided within three months of first publication Statistical Analysis Plan Data will be share within 3 months of completion of the trial controlled access
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