| CTRI Number |
CTRI/2025/05/087868 [Registered on: 29/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on how a multimedia learning affects knowledge and anxiety in patients with autoimmune disorders undergoing plasmapheresis at AIIMS New Delhi |
|
Scientific Title of Study
|
A study to assess the effect of multimedia learning module on knowledge and pre-procedural anxiety of patients undergoing plasmapheresis with autoimmune disorders at neurosciences 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 |
JATIN KUMAR |
| Designation |
M.Sc. Nursing Student neurosciences |
| Affiliation |
College of nursing, AIIMS New Delhi |
| Address |
Room no-3, Porta cabin college of nursing AIIMS New Delhi
Room no-3, Porta cabin college of nursing AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
09953325224 |
| Fax |
|
| Email |
aryyyyjatin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms. Aditi Prashant Sinha |
| Designation |
Associate professor |
| Affiliation |
Associate professor |
| Address |
Room no-3, Porta cabin college of nursing AIIMS New Delhi
Room no-3, Porta cabin college of nursing AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9810784806 |
| Fax |
|
| Email |
Aaditiprashant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms. Aditi Prashant Sinha |
| Designation |
Associate professor |
| Affiliation |
Associate professor |
| Address |
Room no-3, Porta cabin college of nursing AIIMS New Delhi
Room no-3, Porta cabin college of nursing AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9810784806 |
| Fax |
|
| Email |
Aaditiprashant@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JATIN KUMAR |
| Address |
Pota-Cabin 2 College Of Nursing AIIMS DELHI 110029 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Jatin Kumar |
AIIMS NEW DELHI |
NS3, NS4, NS5 WARDS (3,4, AND 5TH FLOOR) NEUROSCIENCES CENTER
South
DELHI |
9953325224
aryyyyjatin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G35||Multiple sclerosis, (2) ICD-10 Condition: G64||Other disorders of peripheral nervous system, (3) ICD-10 Condition: G610||Guillain-Barre syndrome, (4) ICD-10 Condition: G700||Myasthenia gravis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
multimedia learning module |
A structured multimedia module designed to provide information about plasmapheresis, including its procedure, potential complications, and management strategies. The package may include a structured video, pamphlets, written materials, audiovisual aids, tailored for patients undergoing plasmapheresis. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with autoimmune disorder admitted for first cycle of plasmapheresis
2 Any gender
3 Ability to read and write and understand English or Hindi
4 patients who consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1 patient who doesn’t want to participate in the study.
2 Patients who are critically ill.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To assess the effectiveness of multimedia learning module on knowledge regarding plasmapheresis among patient with auto-immune disorder
2 To assess the effectiveness of multimedia learning module on pre-procedural anxiety related to the plasmapheresis among the patient with autoimmune disorder
|
2 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the association between knowledge levels & demographic variables among patients undergoing plasmapheresis with autoimmune disorders
|
2 WEEKS |
To determine the association between anxiety levels & demographic variables in patients undergoing plasmapheresis with autoimmune disorders.
|
2 weeks |
| To examine the relationship between knowledge levels & anxiety levels among patient undergoing plasmapheresis with autoimmune disorders |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2025 |
| 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 Yet Recruiting |
| 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 research seeks to assess the efficacy of a multimedia education module in improving understanding and lowering pre-procedural anxiety in patients receiving plasmapheresis for autoimmune conditions at the Neurosciences Centre, AIIMS New Delhi. Plasmapheresis is a crucial procedure for survival; however, it may cause considerable anxiety because patients often lack knowledge and fear possible complications. A multimedia module designed with videos, animations, and interactive components will be utilized to inform patients about the procedure. The research employs a quasi-experimental framework utilizing a pre-test and post-test method to assess variations in knowledge and anxiety levels. The main outcomes consist of enhanced knowledge and decreased anxiety, whereas secondary outcomes evaluate patient satisfaction, adherence to pre-procedural guidelines, and the relationship between knowledge and anxiety. Results from this study may assist in incorporating multimedia education into everyday clinical practice, resulting in improved patient readiness and outcomes.
|