| CTRI Number |
CTRI/2024/01/061183 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the impact of education teaching given by nurse for infection control with follow up teleconsultation on incidence of febrile neutropenia and caregivers’ knowledge among parents of children with acute leukemia at AIIMS, New Delhi |
|
Scientific Title of Study
|
A study to assess the impact of nurse-led education bundle for infection control with follow up teleconsultation on incidence of febrile neutropenia and caregivers’ knowledge among parents of children with acute leukemia at 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 |
Charul |
| Designation |
MSc Nursing student |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
277,Katra Gulkhan Near Robin Cinema Subzi Mandi Delhi- 110007
South
DELHI
110007
India |
| Phone |
8744832321 |
| Fax |
|
| Email |
charul1196@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
L Levis Murry |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
College of Nursing, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
7838990810 |
| Fax |
|
| Email |
levis.murry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
L Levis Murry |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
College of Nursing, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
7838990810 |
| Fax |
|
| Email |
levis.murry@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, 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 Rachna Seth |
All India Institute of Medical Sciences, New Delhi |
Room no 210, New Rajkumari Amrit Kaur OPD, Department of Pediatrics
South
DELHI |
9971188687
drrachnaseth@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESERACH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of children with acute leukemia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Nurse Led Intervention |
One to one teaching with the help of flip chart, leaflets and pamphlets as developed by the researcher for the caregivers of children with acute leukemia, for the purpose of the study and pamphlets were given to each participants.
Time duration is 25 minutes for explanation and doubt clarification of caregivers.
Content includes what is febrile neutropenia, what are the red flag signs in chemotherapy, management during chemotherapy like oral care, hair care, rectal care, skin care, respiratory etiquettes, prevention from infections, sleep and exercise, diet and hydration.
Skill building on handwashing and temperature monitoring.
Explain about the sick card.
Care of PICC line and Intravenous line.
Motivate to attend sambhav meeting.
Follow up and adherence to the treatment. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Caregivers of children diagnosed with acute leukemia who are receiving the first cycle of Chemotherapy treatment at AIIMS, New Delhi
Caregivers of children who will be able to understand Hindi / English language.
Caregivers who are willing to participate in the research.
Children with leukemia should lie in the age group between 0-18yrs
|
|
| ExclusionCriteria |
| Details |
Children with comorbidities
Patients who are not willing to participate in the study.
Patients who could not comprehend or respond to the questionnaire in Hindi or English
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of nurse led education bundle for infection control with follow up teleconsultation among caregivers on incidence of febrile neutropenia on children with acute leukemia |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the impact of nurse-led education bundle for infection control with follow up teleconsultation on caregivers’ knowledge of febrile neutropenia.
To assess the impact of nurse-led education bundle for infection control with follow up teleconsultation on caregivers’ practice. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
12/01/2024 |
| 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="1"
Months="0"
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
|
Children with acute leukemia have to go through chemotherapy. Chemotherapy have many side effects . Among all the side effects, Febrile neutropenia is one of the severe complication and can be life threating if not treated on time. Teleconsultation is a feasible tool especially in case of cancer patients because it reduces the exposure of contagious diseases among children with cancer as they are already immunocompromised. Researcher wants to give one to one teaching with the help of flip chart, leaflets and pamphlets as developed by the researcher for the caregivers of children with acute leukemia, for the purpose of the study and pamphlets were given to each participants. Time duration for intervention includes 25 minutes for explanation and doubt clarification of caregivers. Content of nurse led intervention includes what is febrile neutropenia, what are the red flag signs in chemotherapy, management during chemotherapy like oral care, hair care, rectal care, skin care, respiratory etiquettes, prevention from infections, sleep and exercise, diet and hydration, Skill building on handwashing and temperature monitoring, Explain about the sick card, Care of PICC line and Intravenous line, Follow up and adherence to the treatment.
Hence the researcher aim to assess the effectiveness of nurse led education bundle for infection control with teleconsultation on incidence of febrile neutropenia, caregivers knowledge and practice on prevention and management of febrile neutropenia. |