| CTRI Number |
CTRI/2022/07/044441 [Registered on: 28/07/2022] Trial Registered Prospectively |
| Last Modified On: |
29/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Practice of decreasing anxiety before surgery in children |
|
Scientific Title of Study
|
Allaying paediatric preoperative anxiety, Where Are We Now? – A nationwide survey |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreya Shah |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no.6, Porta Cabin, 4th Floor, Main Building, Ward block, Department of Anaesthesiology, A.I.I.M.S, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
09892652781 |
| Fax |
|
| Email |
shreyabs@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shreya Shah |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no.6, Porta Cabin, 4th floor, Main Building, ward block, Department of Anaesthesiology, A.I.I.M.S, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
09892652781 |
| Fax |
|
| Email |
shreyabs@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shreya Shah |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no.6, Porta Cabin, 4th floor, Ward Block, Main Building, A.I.I.M.S, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
09892652781 |
| Fax |
|
| Email |
shreyabs@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Material support-A.I.I.I.M.S, New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Pain Medicine and Critical Care AIIMS New Delhi |
| Address |
Ansari Nagar, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shreya Shah |
All India Institute of Medical Sciences |
Department of Anaesthesiology, Ansari Nagar, New Delhi
New Delhi
DELHI |
9892652781
shreyabs@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Practicing Anaesthesiologists |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Life members of Indian Society of Anaesthesiologists
Willing to participate in the study
Able to understand English
|
|
| ExclusionCriteria |
| Details |
Anaesthesiologists practicing outside India.
Not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To find out adherence to the practice of using anxiety alleviating strategies for preoperative anxiety in children and the reasons of not following them
2. The choice of technique in routine use and reasoning behind the choice
3. Strategies utilised in special situations
|
Preoperative, after 1 hour, after 2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objectives were to evaluate the practice in terms of sedative premedication drugs used, behavioural interventions used, the problems encountered, risk benefit of one method over the other. |
Preoperative, after 1 hour of anaesthesia, after 2 hours |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
Final Enrollment numbers achieved (Total)= "450"
Final Enrollment numbers achieved (India)="450" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2022 |
| Date of Study Completion (India) |
28/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Preoperative anxiety (PA) in children is a common phenomenon associated with medical environments. PA is associated with immediate adverse outcomes, both behavioural and clinical . Due to the immediate and potentially more long-term negative effects of PA, a number of prevention and intervention strategies have been examined to alleviate anxiety and decrease the development of negative behaviours post-surgery. Both pharmacological (e.g., sedative premedication) and nonpharmacological (e.g., parental presence, video-distraction, behavioural preparation programs, music etc.) approaches have proven useful. Considering the high incidence and the associated adverse outcomes it would be worthwhile to know if these anxiety relieving practices are being followed in our country. A nationwide survey may possibly shed some more light on the practice patterns which are not well documented and have been described only in the British literature. It may help identify the unreported hurdles to it’s implementation and bridge the lacunae in the existing literature. We therefore designed this mailing survey to assess the current practices of prevention and treatment of PA in children among the anaesthesiologists in India with the hope of contributing to the future establishment of a standardised nationwide practice. The questionnaire is prepared in English, has three sections: Section 1: Demographic data of the respondent Section 2: Anxiety relieving strategies 2a. Sedative premedication (including special situations) 2b. Behavioural interventions/non-pharmacological methods Section 3: Attitude The questionnaire will be distributed via E�’mail or electronic media to the members of the Indian Society of Anaesthesiologists. Two reminders 10 days apart will be sent to those who do not respond. Participants will be requested to fill the questionnaire only once. Completion and submission of questionnaire by the respondents will imply their consent. To maintain respondent anonymity, no personal identifying information will be enquired in the survey. |