| CTRI Number |
CTRI/2021/07/034784 [Registered on: 12/07/2021] Trial Registered Prospectively |
| Last Modified On: |
08/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A scientific study to assess the effectiveness of nurse-led counselling on parents of children with Congenital Adrenal Hyperplasia |
|
Scientific Title of Study
|
A pre-experimental study to assess the effectiveness of nurse-led counselling on psycho-social problems, knowledge, practices and treatment adherence among parents of children with Congenital Adrenal Hyperplasia attending Pediatric Endocrinology OPD PGIMER, Chandigarh 2020-22 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poonam Verma |
| Designation |
student |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Room No. 225,National Institute of Nursing Education, PGIMER, Chandigarh
Room No. 225, National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9779538590 |
| Fax |
|
| Email |
poonamvermanayyar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukhwinder Kaur |
| Designation |
Lecturer, NINE, PGIMER, Chandigarh |
| Affiliation |
National Institute of Nursing Eduaction, PGIMER, Chandigarh |
| Address |
Room No. 225, National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417100081 |
| Fax |
|
| Email |
sukhwinder_dr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukhwinder Kaur |
| Designation |
Lecturer, NINE, PGIMER, Chandigarh |
| Affiliation |
National Institute of Nursing Eduaction, PGIMER, Chandigarh |
| Address |
Room No. 225, National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417100081 |
| Fax |
|
| Email |
sukhwinder_dr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Poonam Verma |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sukhwinder Kaur |
Room No. 225 National Institute of Nursing Education PGIMER Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Poonam Verma |
PGIMER, Chandigarh |
Endocrinology OPD,Room no. 3419, 3420, 3-D,APC.
Chandigarh
CHANDIGARH |
9779528590
poonamvermanayyar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER Chandigarh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nurse-led counselling |
counselling of parents of children with CAH about their psychosocial problems and providing them information about disease condition, specific procedures involving early detection, management of symptoms and adherence to treatment.
comparison will be pre intervention and after intervention in same group |
| Intervention |
nurse-led counselling |
individual or group counselling of parents of children with CAH about their psychosocial problems and providing them information about disease condition, specific procedures involving early detection, management of symptoms and adherence to treatment. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
parents of children upto 12 years of age with CAH attending Pediatric Endocrinology OPD PGIMER Chandigarh |
|
| ExclusionCriteria |
| Details |
Parents of children having any other genetic/medical disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the effectiveness of nurse-led counselling on psychosocial problems, knowledge, practices and treatment adherence among parents of children with Congenital Adrenal Hyperplasia attending Pediatric Endocrinology OPD, APC, PGIMER, Chandigarh, 2020-22. |
at baseline, after intervention same day, at 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the baseline psychosocial problems, knowledge, practices and treatment adherence among parents of children with CAH.
2. To develop and implement a nurse led counselling for parents of children with CAH.
3. To assess the effectiveness of nurse led counselling on psychosocial problems, knowledge, practices and treatment adherence among parents of children with CAH.
|
1 month and 2 month |
|
|
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)
|
16/07/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a pre-experimental (one group pre-test post-test design). nurse-led intervention will be planned in the form of a booklet to provide knowledge to the parents about the disease, its inheritance pattern, possible treatment options and prevention. psycho-social issues, knowledge, practices and treatment adherence will be assessed by different tools pre-intervention and then after intervention and follow-up will be done at 1 month and 2 month. |