| CTRI Number |
CTRI/2024/05/067827 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [video based teaching] |
| Study Design |
Other |
|
Public Title of Study
|
Impact of video teaching on knowledge and anxiety of family members & patients undergoing EEG |
|
Scientific Title of Study
|
A Study to assess the effectiveness of family and patient education using a video based teaching on knowledge and pre procedural anxiety of family members & patients undergoing EEG at AIIMS, New Delhi. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N/A |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran Shah |
| Designation |
M.Sc. Nursing (Critical Care Nursing) |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing, Porta Cabin 2, Second Floor, Near Old OT Block, AIIMS, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8126082727 |
| Fax |
|
| Email |
simranshah897@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms. Sibi Riju |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing, Room No 5 , First Floor, Near Old OT Block, AIIMS, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9958879808 |
| Fax |
|
| Email |
sibiriju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms. Sibi Riju |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing, Room No 5 , First Floor, Near Old OT Block, AIIMS, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9958879808 |
| Fax |
|
| Email |
sibiriju@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS New Delhi, Address CON, AIIMS, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
College of Nursing,near old OT block, AIIMS, Ansari Nagar, New Delhi,110029 |
| 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 |
| Dr Mamta Bhushan Singh |
All India Institute Of Medical Sciences |
Cardiothoracic & Neuroscience building, first floor, room no 49, AIIMS, New Delhi
New Delhi
DELHI |
9818835305
mbsneuro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES ANSARI NAGAR NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G409||Epilepsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
video based teaching |
video based teaching regarding EEG, intervention will be given to family members and patients on the day of appointment.
Duration of intervention- 20-30 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
For Patients
Patients suffering from neurological conditions.
Patients 18yrs or above
Understand Hindi or English
Attending neurology OPD, AIIMS, New Delhi and has been advised EEG for the first time.
For family members
Age 18 yrs or above
Understands Hindi or English
Who accompanies the patient to OPD and are related to them.
|
|
| ExclusionCriteria |
| Details |
family members & patients
who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in knowledge and decrease in pre procedural anxiety among family members and patients undergoing EEG at AIIMS, New Delhi |
It will be assessed two times first on the day when patients come to OPD for EEG appointment & second on the day of EEG |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A study to assess the effectiveness of family and patient education using a video based teaching on knowledge and pre procedural anxiety of family members and patients undergoing EEG at AIIMS, New Delhi.
Aim- To assess the impact of video based teaching on knowledge and preprocedural anxiety of family members and patients undergoing EEG at AIIMS, New Delhi.
primary objectives 1. To develop a video based teaching on EEG. 2. To assess and compare pre and post test knowledge of family members and patients undergoing EEG at AIIMS New Delhi. 3.To assess and compare the level of pre- procedural anxiety before and after implementation of video based teaching among family members and patients undergoing EEG at AIIMS, New Delhi.
Design- Quasi experimental Tool 1- socio-demographic variables performa and clinical profile of patient. Tool2- structured knowledge questionnaire regarding EEG Tool 3- GAD-7 anxiety assessment scale |