| CTRI Number |
CTRI/2024/05/068074 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [OBSERVATION OF SEIZURE] |
| Study Design |
Other |
|
Public Title of Study
|
A study to develop a guideline of assessing and managing seizure for Nurses Working in neuro science center. |
|
Scientific Title of Study
|
A study to Assess the Effectiveness of Structured Nursing Guideline on Seizure Action Plan in term of knowledge and practice of Nurses working in Neuroscience Centre AIIMS New Delhi |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaansher Khan |
| Designation |
M.Sc Studdent |
| Affiliation |
College of Nursing AIIMS New Delhi |
| Address |
Porta cabin 2,second floor,College of Nursing
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9950860985 |
| Fax |
|
| Email |
itsjaishkhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sibi Riju |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing AIIMS New Delhi |
| Address |
Room No.5,College of Nursing,
near old OT Block, AIIMS Campus
South
DELHI
110029
India |
| Phone |
9958879808 |
| Fax |
|
| Email |
sibiriju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaansher Khan |
| Designation |
M.Sc Student |
| Affiliation |
College of Nursing, AIIMS New Delhi |
| Address |
Porta cabin 2,second floor,College of Nursing
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9950860985 |
| Fax |
|
| Email |
itsjaishkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing, All India Institute of Medical Science New Delhi |
|
|
Primary Sponsor
|
| Name |
College of Nursing AIIMS New Delhi |
| Address |
Near Old Ot block, Ansari NAGAR AIIMS 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 Manjari Tripathi |
AIIMS New Delhi |
NS4 ward, NSC(Neuroscience),CN Center
South
DELHI |
8929919736
Manjari.tripathi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee for Post Graduate, AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G408||Other epilepsy and recurrent seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
As study is quasi experimental no control group is required. |
| Intervention |
Structure Nursing Guidelines on Seizure action Plan
|
INTERVENTION- Structure Nursing Guidelines on Seizure action Plan
Development of structure nursing guideline on seizure action plan for nurses. The guideline will be made under the guidance of guide, co guide and experts from neurology department.
Components Of seizure action plan-Following Component may be included bases on the various study
1. Is it seizure/Early recognition of seizure.
2. Prompt action in response to acute seizure
3. Care and assessment during seizure
a. Medication Administration (prescribed and SOS)
b. Assessment includes response, speech and motor function
c. Prevention of injury
d. Prevention of complication
4. Care and assessment after seizure stop-
a. Post ictal behaviors
b. And memory assessment
5. Prevention of associated complications
The guideline will be taught to the nurses in small group of 5-6 nurses. The teaching will be conducted for 30-45minute and handout for the same will be distributed after the lecture. Doubt of nurses will be cleared as same day. Five rounds will be conducted to train 30 nurses after all trained the same will be implemented in routine care of admitted patient having seizure. The patient outcome will be monitored.
Knowledge and practice of nurses for assessing and managing seizures(seizure action plan) will be recorded at 2 time points, t0 (baseline) before intervention and t1 1 week after intervention.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
For Nurse-
Nurses willing to participate in study.
Nurses Caring for patient having seizure.
For Patient-
Patient admitted with any neurological or neurosurgical condition and having seizure.
Patient willing to participate.
|
|
| ExclusionCriteria |
| Details |
For nurse –
Nurses not available at the time of data collection.
For patient
Patient with status epilepticus.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop a seizure action plan for seizure obervation and management by nurses. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the knowledge and practice of nurses for assessing and managing seizure in neurology ward. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/06/2024 |
| 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
|
This is Quantitative study and design is Quasi Experimental One Group Pre-Test Post-Test Design at the Neuro Science Center AIIMS New Delhi. Study Process- Pre implementation FOR NURSES Pre test knowledge and practice of nurses will be assessed after taking informed consent and explaining purposes of the study. The intervention in the form of structured nursing guideline will be taught to the nurses. Post test knowledge will be assessed after 1 week of intervention FOR PATIENTS- Base line patient outcome of seizure management will be monitor. The out comes will be patient falls, other complications (injuries) and time to treatment. implementation - structured Seizure Action plan(Assessment and management of seizure) implemented in the routine practice in neurology ward. post implementation For Nurses -Evaluation of practice of nurses on seizure action plan will be done by observation checklist For Patient- Patient outcomes will be monitored by outcome assessment sheet on all three selected. |