| CTRI Number |
CTRI/2016/02/006585 [Registered on: 01/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
25/01/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [nurse led teaching programme] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized control trial to assess the effectiveness of discharge counselling for the pediatric surgical patient and their parents in pediatric surgical ward. |
|
Scientific Title of Study
|
A randomized control trial to assess the effectiveness of discharge counselling for the pediatric surgical patient and their parents in pediatric surgical ward at, AIIMS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Punam |
| Designation |
M.Sc Nursing |
| Affiliation |
COLLEGE OF NURSING, AIIMS |
| Address |
M.SC NURSING ROOM
2ND FLOOR
COLLEGE OF NURSING, AIIMS
NEW DELHI-110029
South
DELHI
110029
India |
| Phone |
8860802562 |
| Fax |
|
| Email |
punamgurjar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Vatsa |
| Designation |
Principal |
| Affiliation |
College of nursing, AIIMS |
| Address |
Principal
college of nursing
aiims
new delhi
South
DELHI
110029
India |
| Phone |
98910131175 |
| Fax |
|
| Email |
mvatsa2001@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
PUNAM |
| Designation |
M.Sc NURSING |
| Affiliation |
COLLEGE OF NURSING, AIIMS |
| Address |
M.SC ROOM
2ND FLOOR
COLLEGE OF NURSING
AIIMS
South
DELHI
110029
India |
| Phone |
8860802562 |
| Fax |
|
| Email |
punamgurjar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
COLLEGE OF NURSING
AIIMS
NEW DELHI-10029 |
| Type of Sponsor |
Research institution |
|
|
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 |
| PUNAM |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
AB5 WARD
5TH FLOOR
MAIN BUILDING
AIIMS
NEW DELHI
110029
South West
DELHI |
8860802562
punamgurjar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
pediatrics surgical patients and their who are admitted in pediatric surgical ward., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
discharge counselling plan |
This plan which is use as comprehensive discharge counselling which should be administered to group during their hospital stay from admission to discharge. This plan included all important information which is required for the pediatric surgical patients after discharge; Content of the plan as follow:Content:- general and specific instructions. General instruction regarding: Breast feeding, Diet, Rest and activity, Personal hygiene, complication, Danger sign’s, Follow up, immunization.
Special instructions regarding: Wound care, Stoma care, Catheter or tube care, Tube feeding, Chest physiotherapy.
The procedure which are required to demonstrate like stoma care, catheter care, tube feeding, chest physiotherapy etc will be demonstrated by researcher or by showing videos and charts, regarding others care like breast feeding, immunization, danger sings, follow up etc will be discuss among the subjects by researcher |
| Comparator Agent |
discharge counselling plan |
This plan which is use as comprehensive discharge counselling which should be administered to group during their hospital stay from admission to discharge. This plan included all important information which is required for the pediatric surgical patients after discharge; Content of the plan as follow:Content:- general and specific instructions. General instruction regarding: Breast feeding, Diet, Rest and activity, Personal hygiene, complication, Danger sign’s, Follow up, immunization. Special instructions regarding: Wound care, Stoma care, Catheter or tube care, Tube feeding, Chest physiotherapy. The procedure which are required to demonstrate like stoma care, catheter care, tube feeding, chest physiotherapy etc will be demonstrated by researcher or by showing videos and charts, regarding others care like breast feeding, immunization, danger sings, follow up etc will be discuss among the subjects by researcher |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric surgical patient and their parents:
-Age upto 14 years.
-Specified diagnosis related to gastrointestinal, oncological, genitourinary tract and respiratory tract.
-Comprehend in Hindi/English.
-Willing to participate in the study.
-Discharge after the specified surgical intervention.
Discharge after the specified surgical intervention.
|
|
| ExclusionCriteria |
| Details |
those who are not included in inclusion criteria |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| there will be reduced readmission, complication, frequent OPD and emergency visits, need to seek medical consult elsewhere, better home and higher satisfaction level. |
nil |
|
|
Secondary Outcome
|
|
|
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)
|
25/10/2015 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
According to previous nursing study of masters student (2010-2012) Jeen Varghese, AIIMS, there is a need of improvement in discharge counselling content, which is provided to pediatric surgical patients and their parents in pediatric surgical ward at AIIMS. I hypothesized that the pediatric surgical patients and their parents who receive discharge counselling plan will have reduced readmission, complication, frequent OPD and emergency visits, need to seek medical consult elsewhere, better home care and higher satisfaction level.
|