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.: PACTR202103591612264 Date of Approval: 03/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Parental active participation during induction of general anesthesia to decrease children anxiety and pain
Official scientific title Parental active participation during induction of general anesthesia to decrease children anxiety and pain
Brief summary describing the background and objectives of the trial Background: Pre-operative anxiety is very common in children. On the day of surgery, 50 to 70% of children experience anxiety that usually peaks during induction of anesthesia (1). Preoperative anxiety is associated with problematic induction of anesthesia, risk of emergence delirium, increased pain and poorer recovery (2). These adverse outcomes underscore the urgent need for effective interventions to reduce pre-operative anxiety. Parental presence during induction of anesthesia, sedative premedication and psychological support were evaluated in many previous trials with conflicting results (3).active participation of parents in induction of anesthesia has not been evaluated before .Finding a positive role for parents during preoperative period could result in reducing child fear and anxiety and better outcome. Aim of the study: The aim of this study is to evaluate the effect of parent active participation in induction of anesthesia on preoperative anxiety, in addition to postoperative outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2020
Actual trial start date 01/01/2021
Anticipated date of last follow up 01/05/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group parent active participation during induction of anesthesia during induction of anesthesia one of the parents will share in induction of anesthesia 50
Control Group non active participation of parents during induction of anesthesia The objective of the current study to compare levels of anxiety during induction of anesthesia (primary outcome), postoperative anxiety, observed pain, emergence delirium, and need to rescue analgesia (secondary outcomes) in children. None of the children will receive pre-operative anxiolytic, premedication. All children will be subjected to inhalational induction with sevoflurane in a mixture of oxygen and air. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children scheduled for elective day case orthopedic surgeries will be selected with the following inclusion criteria: age :3-8 years old, American Society of Anesthesiologists (ASA) grade I-II. Exclusion criteria were mental retardation , epilepsy , visual impairment, history of previous surgery and or hospitalization, chronic illness, (ASA) physical status at least III and need for pre-operative anxiolytic medication. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 8 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 21/05/2020 Ethics committee Faculty of medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
7 Champollion Street, El Messalah, alexandria 21568 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • The primary outcome is child anxiety during induction of anesthesia assessed with the modified Yale Preoperative Anxiety Scale (mYPAS).(4) The mYPAS is considered the gold standard in observational instruments to assess pre-operative anxiety in children and will be completed at three timepoints: baseline upon hospital admission, in holding area before induction of anesthesia, and during induction of anesthesia). The mYPAS consists of 27 items divided into five domains: activity, emotional expressivity, state of arousal, vocalization and use of parents. Scores range from 23.33 to 100, with higher scores indicating higher levels of anxiety. • Children will indicate their own anxiety level on a six- facial visual facial anxiety scale (VFAS) (5) and will be completed at three time points: baseline upon hospital admission, in holding area before induction of anesthesia, and after surgery. baseline upon hospital admission, in holding area before induction of anesthesia, and after surgery
Secondary Outcome • Child pain and emergence delirium: postoperative pain will be reported by two informants; children will report their pain intensity with the six-faces revised Faces Pain Scale (FPS-r): range 0 to 10. A blinded recovery nurse will assess pain intensity with the Face, Legs, Activity, Cry and Consolability (FLACC) scale: range 0 to 10. Emergence delirium will be assessed with the Pediatric Anesthesia Emergency Delirium (PAED) scale by a blinded recovery nurse: range 0 to 20. postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Hadara University hospital El Mostashfa El Italy St. El Hadara Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tarek I. Ismail 152 TIBA st., Sporting Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tarek Ismail sabry Mohamed Ismail 152 TIBA st., sporting ALEXANDRIA Egypt Individual
Secondary Sponsor Rabab Mahrous el sultan Hussein st., El shatby Alexandria Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Rabab Mahrous Anesthesia Department, El Sultan Hussein El shatby, Faculty of Medicine, Alexandria University Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tarek Ismail Sabry Mohamed Ismail drtarek.anesth@gmail.com 00201001467166 152 tiba st. sporting
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Anesthesia and Surgical Intensive Care Helwan University Egyp
Role Name Email Phone Street address
Public Enquiries Amal Mohamed amalasaic@gmail.com +201281560053 Faculty of Medicine, El Sultan Hussein St. Anesthesia Department
City Postal code Country Position/Affiliation
Alexandria Egypt Secretary of Research and opinion in Anesthesia and intensive care Journal
Role Name Email Phone Street address
Scientific Enquiries Tarek salem tareksalem00@gmail.com 00201112277417 Al Gamaa, Al Masaken Al Iqtisadeyah, Qism Helwan
City Postal code Country Position/Affiliation
Alexandria Egypt Vice dean of graduate studies and Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Pateint data in excel sheet summary of results will be will be included within 12 months after study completion Statistical Analysis Plan,Study Protocol within 12 months after completion open access to IPD to reviewers. Data will be send directly by email upon request.
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